Current News

Date Title
03/12/2018 New Study Investigates the Performance of Masimo SpHb® During Acute Bleeding and After Fluid Resuscitation
03/06/2018 Masimo Announces Replica™
02/26/2018 Leading Nephrology Care Center in India Adopts Masimo Technologies
02/22/2018 New Study Evaluates the Performance of Masimo SpHb® in Monitoring
02/12/2018 New Study Evaluates the Performance of Masimo PVi® as a Predictor of Fluid Responsiveness in Mechanically Ventilated ICU Patients
02/07/2018 Masimo Announces CE Marking of Eve™ CCHD Newborn Screening Application for the Rad-97™ Pulse CO-Oximeter®
01/30/2018 Masimo to Report Fourth Quarter and Full Year 2017 Financial Results after Market Close on Tuesday, February 27
01/29/2018 Masimo Announces FDA Clearance of Next Generation SedLine®
01/22/2018 New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™, in Obese Patients
01/09/2018 Masimo Announces FDA Clearance for Home Use of Rad-97™
01/02/2018 Masimo Announces CE Marking and Release of Oxygen Reserve Index™
12/01/2017 Artemis Hospital Becomes First in India to Adopt Masimo Patient SafetyNet™ Across All Hospital Care Areas
11/27/2017 Masimo Announces FDA Clearance and Worldwide Release of NomoLine™ Capnography Sampling Lines
11/13/2017 Masimo Supports World Pneumonia Day Efforts
11/07/2017 Masimo Announces Distribution of Rad-57® Pulse CO-Oximeters® by The Jeffrey Lee Williams Foundation to First Responders
10/16/2017 San Diego Bankruptcy Court Rules Sotera Employees Misappropriated Masimo Trade Secrets
09/28/2017 Masimo Announces Full Market Release of rainbow Acoustic Monitoring Sensor RAS-45
09/18/2017 Masimo Announces FDA Clearance and Full Market Release of Rad-97™Pulse CO-Oximeter®
09/14/2017 Newborn Foundation and Masimo Partnership Reaches 52,000 Babies and 1,000 Health Workers through Newborn Screening Initiative in Support of Every Woman Every Child
09/05/2017 Study Evaluates Performance of Masimo iSpO2® Rx Smart Device-Paired Pulse Oximeter in Screening Newborns for Critical Congenital Heart Disease
08/28/2017 Study Evaluates Utility of Masimo SpHb® During High-Blood-Loss Oncosurgery
08/21/2017 Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery
08/14/2017 Dubai Health Authority Implements Masimo Patient SafetyNet™
08/07/2017 Study Evaluates Performance of Masimo SpHb® in Trauma Patients
07/31/2017 Study Compares Performance of Masimo Acoustic Respiration Rate (RRa®) and Nellcor Plethysmographic Respiration Rate in Volunteers
07/20/2017 Masimo Announces CE Marking of Noninvasive RPVi™, a rainbow® Multi-Wavelength Index of Pleth Variability
07/10/2017 Masimo Announces CE Marking of rainbow® Super Sensor
06/19/2017 New Study Compares Performance of Masimo Next Generation SedLine® Patient State Index (PSi) to Original PSi During Anesthesia
06/05/2017 Masimo Announces Limited Market Release of Rad-67™ rainbow® Pulse CO-Oximeter® with Next Generation SpHb®
06/01/2017 Masimo and Mdoloris Announce Masimo Open Connect™ (MOC) Partnership for the Root® Patient Monitoring and Connectivity Hub
05/30/2017 Masimo Announces FDA 510(k) Clearance of O3™ Regional Oximetry for Pediatric Patients
05/19/2017 Masimo Announces the Full Market Release of Early Warning Score (EWS) with the Root® Patient Monitoring and Connectivity Hub
05/15/2017 Midmark, Masimo Announce Partnership to Improve Vital Signs Acquisition
05/15/2017 Multicenter Study at UC Davis, UC Los Angeles, and Mayo Clinic Evaluates the Trend Accuracy of Masimo Continuous SpHb®
05/09/2017 Masimo Introduces Rad-G™ Pulse Oximeter
04/11/2017 Two Fire Rescue Departments Honored for Excellence in Emergency Medical Services
04/10/2017 Masimo Announces Full Market Release of Root® Patient Monitor and Connectivity Hub with Kite™ Supplemental Display System
03/27/2017 Massena Memorial Hospital of New York Adopts Masimo Root® and Masimo Patient SafetyNet™
03/20/2017 Masimo Announces CE Marking of Rad-97™ Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure
03/13/2017 New Study Evaluates the Utility of Masimo SpHb® Monitoring During Liver Transplantation
03/06/2017 Masimo Announces Availability of the RD SedLine® Adult EEG Sensor
02/27/2017 New Study Assesses the Utility of Masimo PVi® Monitoring During Colorectal Surgery
02/21/2017 Masimo Announces Recent Study Monitoring Methemoglobin Levels During Administration of Inhaled Nitric Oxide
02/15/2017 Masimo Announces CE Marking of Respiration Rate Measurement on MightySat™ Rx
02/01/2017 Masimo Announces the Addition of Early Warning Score to the Root® Patient Monitoring and Connectivity Platform
01/02/2017 Masimo Reaffirms Commitment to India with Launch of Advanced Monitoring Technologies Made for India
12/19/2016 Masimo Announces FDA 510(k) Clearance for TFA-1™ Single-Patient-Use Forehead Sensor
12/06/2016 Giving Back with Masimo
11/11/2016 Masimo Receives Gates Foundation Grant to Develop Combined Pneumonia-Screening Device for High-Burden Settings
11/07/2016 Philips and Masimo Sign Multi-Year Business Partnership Agreement in Patient Monitoring and Select Therapy Solutions
10/22/2016 Study Investigates the Impact of Masimo Continuous SpHb® and PVI® on Anesthesia-related Mortality
10/06/2016 Masimo Announces CE Marking of Rad-97™ Pulse CO-Oximeter®
10/02/2016 Masimo Honors Birthday of Mahatma Gandhi with Global Holiday
09/30/2016 Masimo Partners with Smile Train to Advance Safe Surgery
09/26/2016 Masimo Foundation Co-Founds United for Oxygen Alliance
09/15/2016 Study on Abdominal Surgical Patients Investigates Clinical Utility of Masimo PVI®
09/09/2016 New Study Finds Continuous, Noninvasive Hemoglobin Monitoring Using Masimo SpHb® May Reduce Intraoperative Red Blood Cell Transfusion
09/06/2016 Masimo MightySat™ is Available at Apple.com and Select Apple Retail Stores in the US and Canada
09/02/2016 Masimo Announces Amendment to Nellcor Royalty Agreement
08/29/2016 Masimo Announces a Special Worldwide Program for Total Hemoglobin (SpHb®) Monitoring for Areas Affected by the Zika Virus
08/29/2016 Masimo Announces Four-Year Partnership with World Federation of Societies of Anaesthesiologists (WFSA)
08/18/2016 Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate
08/15/2016 New Article Showcases an Effective Surveillance System for General Care Units Using Masimo Patient SafetyNet™
08/04/2016 Masimo Announces CE Marking for Pediatric O3™ Regional Oximetry
07/28/2016 Leading Ohio Critical Access Hospital Adopts Masimo Root® with Radius-7® , Radical-7® , and Patient SafetyNet™ to Create Hospital-Wide Wireless Monitoring and Clinician Notification System
07/21/2016 New Study Evaluates Masimo PVI® as a Predictor of Fluid Responsiveness in Patients Undergoing Liver Transplantation
07/14/2016 New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in Evaluating Pediatric Trauma Patients
07/07/2016 One of the World's Leading Centers for Cardiovascular Medicine & Transplantation Adopts Masimo's SedLine® Brain Function Monitoring and O3™ Regional Oximetry
06/28/2016 Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology, Including Continuous SpHb®
06/23/2016 New SunTech Medical CT40 Vital Signs Device to Feature Masimo SET® Pulse Oximetry Technology
06/13/2016 Masimo Announces FDA 510(k) Clearance for O3™ Regional Oximetry
06/08/2016 Masimo Announces Full Market Release of Next Generation SpHb® Spot Check Pronto®
06/02/2016 One of India's Premier Maternal Care Specialists, Motherhood Hospitals, Standardizes on Masimo SET® Technology
05/26/2016 Masimo to Showcase Next Generation SedLine® Brain Function Monitor at 2016 Euroanaesthesia Congress
05/19/2016 Two Fire Departments Honored for Excellence in Emergency Medical Services
05/04/2016 Masimo Reports First Quarter 2016 Financial Results
04/21/2016 One of France's University Hospitals Adopts Masimo Radical-7®, Including SpHb®, PVI®, and SET® Pulse Oximetry
04/20/2016 Masimo to Report First Quarter 2016 Financial Results after Market Close on Wednesday, May 4
03/31/2016 New Clinical Study Reports Relationship Between Masimo's Oxygen Reserve Index (ORI™) and Arterial Partial Pressure of Oxygen During Surgery
03/17/2016 New Study Reports on Accuracy of Masimo's Blue® Sensors at Saturations Below 85% in Children with Cyanotic Congenital Heart Disease
03/02/2016 Masimo Introduces SafetyNet™ Surveillance at HIMSS16
03/01/2016 Masimo Announces Iris™ Gateway at HIMSS16
02/25/2016 Manipal Hospitals is the First in India to Adopt Masimo Patient SafetyNet™
02/17/2016 Masimo Announces FDA 510(k) Clearance for Root® with Noninvasive Blood Pressure and Temperature
02/12/2016 Masimo's rainbow® Acoustic Monitoring (RAM™) was Associated with Fewer Alarm Events During Planned Moderate Sedation in New Clinical Study
02/04/2016 In New Clinical Study Masimo's Oxygen Reserve Index Helps Clinicians Detect Impending Desaturation in Pediatric Patients
01/29/2016 Masimo to Report Fourth Quarter 2015 Financial Results after Market Close on Tuesday, February 23
01/21/2016 New Study Shows Utility of Masimo rainbow Acoustic Monitoring™
01/19/2016 Dr. Steven Barker Awarded the Society for Technology in Anesthesia's J.S. Gravenstein Award for Lifetime Achievement
01/13/2016 North Carolina's Appalachian Regional Healthcare System Selects Patient SafetyNet™ and Radius-7™
01/06/2016 Masimo to Debut Respiration Rate in MightySat™ at Consumer Electronics Show – First Fingertip Pulse Oximeter to Measure Breath Rate
12/18/2015 Masimo Pledges to Increase Investment in Research & Development in Response to Today's Moratorium on the Medical Device Tax
12/17/2015 Retired U.S. Senator Tom Harkin Joins Masimo's Board of Directors
12/01/2015 T.J. Samson is the First Hospital in Kentucky to Adopt Patient SafetyNet™
11/25/2015 Giving Back With Masimo
11/24/2015 Masimo to Present at 27th Annual Piper Jaffray Healthcare Conference
11/16/2015 India's Leading Maternity and Birthing Care Hospital Group, Cloudnine, Adopts Masimo SET® Technology to Screen Infants for CCHD
11/12/2015 In New Study EMMA™ Capnograph Has Comparable Accuracy to Sidestream Capnography Against Gold-Standard Blood Gas Analysis
11/05/2015 Masimo Reports Third Quarter 2015 Financial Results and Announces New Five Million Share Repurchase Plan
10/29/2015 Two New Clinical Studies Using Masimo Technologies Presented at the American Society of Anesthesiologists Annual Meeting
10/27/2015 Masimo Announces FDA 510(k) Clearance for MightySat™ Rx Fingertip Pulse Oximeter
10/22/2015 Masimo & Atheer to Demonstrate Prototype of Interactive Root® Iris™ Display Powered by AiR™ Smart Glasses Platform
10/22/2015 Masimo to Report Third Quarter 2015 Financial Results after Market Close on Thursday, November 5
10/14/2015 Dr. Steven Barker Awarded the 2015 IAMPOV Lifetime Achievement Award
10/08/2015 Masimo PVI® Evaluated in 18-Study Meta-Analysis For Ability to Help Clinicians Assess Fluid Responsiveness
09/28/2015 Masimo Donates $5 Million in Medical Equipment to Assist Jordan in Providing Healthcare to Over 1 Million Syrian Refugees
09/14/2015 Ranken Jordan Pediatric Bridge Hospital Upgrades their Monitors to the Radical-7® Featuring Masimo SET® Pulse Oximetry
09/08/2015 Masimo to Present at Morgan Stanley Global Healthcare Conference
08/26/2015 Masimo Partners with St. Joseph Hoag Health to Open a Wellness Center for Employees inside their Headquarters
08/25/2015 Brazil's A.C.Camargo Cancer Center Adopts Masimo SpHb for Noninvasive and Continuous Hemoglobin Monitoring
08/05/2015 Masimo Reports Second Quarter 2015 Financial Results
07/13/2015 Masimo Renews its $1,000,000 Performance Guarantee that Masimo SET® Technology will Outperform All Nellcor™ Pulse Oximeters
06/30/2015 Turkey's Leading University Hospital Adopts Masimo SpHb for Continuous Noninvasive Haemoglobin Monitoring
06/22/2015 Masimo Receives CE Mark for MightySat Rx Pulse Oximeter
06/18/2015 Masimo iSpO2 Pulse Oximeter Set to Measure Audience Reaction to
06/15/2015 Masimo Announces Root CE Marking with Blood Pressure and Temperature
06/10/2015 Masimo Root Wins the GOLD 2015 Medical Design Excellence Award
06/05/2015 New Study Presented at the 2015 Euroanaesthesia Congress Evaluated the Impact on Mortality and Morbidity with Masimo SpHb and PVI
05/20/2015 Court Upholds Award of $467 Million to Masimo for Philips' Patent Infringement
05/14/2015 Perioperative Enhanced Recovery Program that Included Masimo PVI Led to Significant Reductions in Length of Stay, Complications and Costs
05/07/2015 Joe Kiani Launches Social Media Presence
05/06/2015 Masimo Reports First Quarter 2015 Financial Results
04/29/2015 Masimo's MightySat Pulse Oximeter Monitoring Elite Athletes at Vertical Blue Freediving Competition
04/24/2015 Masimo Proudly Sponsors Award-Winning Documentary "Personal Gold" During 2015-16 Film Festival Season
04/22/2015 U.S. Chamber of Commerce Presents Masimo CEO Joe Kiani with Intellectual Property Champion Award
04/13/2015 Masimo Announces Patient SafetyNet Series 5000 with Iris Connectivity and MyView
04/09/2015 Three Fire Departments to be Honored for Excellence in Emergency Medical Services
04/02/2015 Illinois Fire Service Institute Is First to Train Firefighters on New Carbon Monoxide Safety Standard
03/31/2015 New Clinical Study Presented at the International Anesthesia Research Society's Annual Meeting Shows Benefit of Masimo's Oxygen Reserve Index, ORI
03/27/2015 Penn Highlands DuBois Installs Masimo SedLine Brain Function Monitoring
03/20/2015 Masimo to Showcase Root® Solutions for the OR and ICU at the International Anesthesia Research Society's 2015 Annual Meeting and International Science Symposium
02/26/2015 Korean Regulators Clear Masimo PVI® for Clinical Use
02/20/2015 CFSI Announces Masimo as Co-Sponsor of the Excellence In Fire Service-Based EMS Award
02/17/2015 Masimo Reports Fourth Quarter and Full Year 2014 Financial Results
02/12/2015 National Fire Protection Association Issues Updated Standard Requiring Firefighters Exposed to Fire Smoke to be Assessed for Carbon Monoxide Poisoning at Incident Scenes and During Training
01/15/2015 Inova Fair Oaks Hospital Casts Masimo Patient SafetyNet™ to Help Improve Patient Outcomes and Reduce Costs
01/06/2015 Masimo Unveils MightySat™ at Consumer Electronics Show - First Fingertip Pulse Oximeter with Masimo SET® Measure-through Motion and Low Perfusion™ Technology
12/30/2014 CES 2015 – Come for the Spectacle, Stay for the Science.
12/16/2014 Masimo Announces Global Launch of Multigas Monitoring for the Root® Patient Monitoring and Connectivity Platform
12/15/2014 Happy Holidays from Masimo!
12/04/2014 Masimo iSpO2™ Pulse Oximeter Featured in Fitness Book by Tour de France Champion Greg LeMond
12/01/2014 Masimo Announces FDA 510(k) Clearance of Radius-7™ – First rainbow® SET® Noninvasive Wearable, Wireless Monitor for Root®
11/05/2014 New Clinical Study Shows Accuracy of Masimo Noninvasive Spot-Check Hemoglobin (SpHb®) in Trauma Patients
10/29/2014 Masimo Reports Third Quarter 2014 Financial Results
10/23/2014 Arkansas Heart Hospital Upgrades to Masimo SET® Pulse Oximetry, Resulting in Significant Reduction in False Alarms and Improved Patient Care and Satisfaction
10/16/2014 Two New Clinical Studies Show Masimo Noninvasive Hemoglobin (SpHb®) Demonstrated Similar Precision as Hemoglobin from Point of Care Devices
10/15/2014 New Clinical Study Presented at the American Society of Anesthesiologists Annual Meeting Shows Benefit of Oxygen Reserve Index™, ORI™
10/14/2014 Retrospective Study of Enhanced Recovery After Surgery Program for Patients Undergoing Colorectal Surgery, which Included Fluid Therapy Tailored to Masimo's PVI®, Showed Reduced Length of Stay and Cost Savings
10/10/2014 Masimo Announces CE Mark of Eve™ Newborn Screening Application for Radical-7, an Intuitive Software Feature to Help Clinicians More Effectively Screen for Critical Congenital Heart Disease
10/07/2014 Masimo Announces CE Mark of the 11th rainbow® Parameter - ORI™, Oxygen Reserve Index™
09/29/2014 Mercy Hospital of Buffalo Expands Use of Masimo Patient SafetyNet™ After Pilot Program Shows Reduction in Mortality
09/25/2014 Masimo Announces MX-5 OEM Circuit Board, Offering Breakthrough rainbow® Pulse CO-Oximetry™ Measurements at 250mW
09/19/2014 Masimo PVI® Helped Assess Fluid Responsiveness in Clinical Study of Adult, Noncardiac Patients
09/04/2014 Yale-New Haven Hospital Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
08/28/2014 Masimo Announces CE Mark and Limited Market Release of rainbow® DCI-mini™ – First Noninvasive Total Haemoglobin (SpHb®) Spot-Check Sensor for Infants and Small Children
08/22/2014 New Clinical Study Evaluates Masimo RAM™ Technology for Tracking Changes in Respiratory Rate in Anesthetized Patients
08/12/2014 New Study of Masimo Noninvasive and Continuous Hemoglobin (SpHb®) Monitoring Evaluates Trending and Accuracy in Pediatric Patients
08/07/2014 Masimo Reports Second Quarter 2014 Financial Results
07/28/2014 Masimo Announces CE Mark and Limited Market Release of Radius-7™ – First rainbow® SET® Noninvasive Wearable, Wireless Monitor for Root®
07/09/2014 New Study Evaluates Trending Accuracy and Reliability of Masimo's Continuous and Noninvasive SpHb® Technology
06/30/2014 Masimo Announces FDA Clearance of Root ™ Patient Monitoring Platform with Capnography, IRIS™ Standalone Device Connectivity, and MOC-9™ Third-Party Measurement Expansion
06/27/2014 Masimo Announces Support for the Every Newborn Action Plan to Reduce Global Newborn Mortality
06/25/2014 Masimo Announces TFA-1™ Transflectance Adhesive Forehead Sensor
06/18/2014 New Study of Masimo Noninvasive and Continuous SpHb® Monitoring Demonstrates Accuracy and Utility in Double-Jaw Surgery
06/12/2014 New Study Shows Masimo Noninvasive SpCO® Helps Clinicians Increase Detection of Carbon Monoxide Poisoning in Emergency Department Patients
06/06/2014 Two Randomized Trials Presented at the Euroanaesthesia 2014 Congress Show Similar Fluid Administration and Risk Profile with PVI as with Invasive or Complicated Procedures
05/21/2014 Masimo Patient SafetyNet™ and SpHb® Noninvasive Hemoglobin Monitoring Enable Clinicians to Meet New Guidance from Centers for Medicare & Medicaid Services
05/15/2014 New Study Shows Masimo SET® Pulse Oximetry Helps Yale-New Haven Children's Hospital Significantly Reduce Retinopathy of Prematurity in Newborns
05/08/2014 Masimo to Present at Bank of America Merrill Lynch 2014 Health Care Conference
05/06/2014 Largest-Ever Study of Newborn Screening for Congenital Heart Disease Again Shows Masimo SET® Pulse Oximetry as Effective Tool
05/02/2014 Masimo Celebrates 25th Anniversary of its Incorporation with Major Initiatives to Improve Patient Safety
04/30/2014 Masimo Reports First Quarter 2014 Financial Results
04/17/2014 Masimo to Report First Quarter 2014 Financial Results after Market Close on Wednesday, April 30
04/07/2014 New Clinical Study Shows Masimo PVI® Helps Clinicians Optimize Fluid Administration in Patients Under Combined General and Epidural Anesthesia
04/04/2014 Masimo Expands Its Board of Directors with Appointment of Medical Device Executive Craig Reynold
03/06/2014 Flagler Hospital Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
03/03/2014 Masimo to Present at 26th Annual ROTH Conference
02/25/2014 North Oaks Medical Center Is First to Integrate Masimo Patient SafetyNet™ with EPIC Electronic Medical Record System
02/21/2014 Masimo to Present at Raymond James 35th Annual Institutional Investors Conference
02/20/2014 Masimo Unveils iSpO2® Pulse Oximeter for Android™
02/19/2014 Masimo to Present at 2014 Citi Global Healthcare Conference
02/14/2014 Masimo Reports Fourth Quarter and Full Year 2013 Financial Results
01/30/2014 Masimo to Report Fourth Quarter and Full Year 2013 Financial Results after Market Close on Thursday, February 13
01/23/2014 Masimo Announces CE Marking of O3™ Regional Oximetry
01/07/2014 Masimo Brings High Technology Medical Equipment to India
01/07/2014 Masimo to Present at 32nd Annual J.P. Morgan Healthcare Conference
12/19/2013 Children's Hospital St. Elisabeth in Neuburg/Donau Installs Masimo Patient SafetyNet™ System for Advanced Care and Oversight of General Ward Patients
12/16/2013 Happy Holidays from Masimo!
12/10/2013 Study Shows Noninvasive SpCO® Helps Clinicians Detect Occult Carbon Monoxide Poisoning
12/09/2013 Masimo and Newborn Foundation Jointly Announce Mobile Health Initiative to Reduce Global Newborn Mortality
11/22/2013 ACUTRONIC Medical Systems Integrates Masimo SET® Pulse Oximetry into fabian HFO Neonatal Critical Care Ventilators for Improved Patient Outcomes
11/18/2013 Masimo Receives 2013 Zenith Award at the American Association of Respiratory Care Congress
11/05/2013 New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock
10/31/2013 Masimo Announces Japan Launch of iSpO2 Pulse Oximeter for iPhone, iPad, and iPod touch
10/18/2013 Masimo to Report Third Quarter 2013 Financial Results after Market Close on Wednesday, October 30
10/17/2013 Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of RAM & PVI
10/08/2013 Multicenter Study Shows Clinical Value of rainbow® Acoustic Monitoring (RAM™)
10/04/2013 EMMA™ Palm Size Capnograph Earns 2013 EMS World Top Innovation Award
09/13/2013 Rochester General Health System Installs Masimo Patient SafetyNet™ for Advanced Care and Oversight of Patients
09/06/2013 Saint Alphonsus Regional Medical Center Installs Masimo Patient SafetyNet™ System for Improved Oversight of Patients
08/29/2013 Firat University Hospital Installs Masimo Patient SafetyNet™ System for Improved Oversight of NICU Patients
08/22/2013 Douglasville Nursing and Rehabilitation Center Installs Masimo Patient SafetyNet™ System for Improved Patient Monitoring
08/16/2013 Pathways Nursing & Rehabilitation Center Standardizes to Masimo SET® Pulse Oximetry
08/06/2013 OU Medical Center Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
07/31/2013 Masimo Reports Second Quarter 2013 Financial Results
07/31/2013 Masimo Announces Eight of Top 10 U.S. Hospitals Now Use Masimo SET® Pulse Oximetry Technology Hospital-Wide
07/23/2013 Community Health Ventures Signs New Supplier Agreement with Masimo
07/16/2013 Masimo to Report Second Quarter 2013 Financial Results after Market Close on Wednesday, July 31
07/15/2013 Masimo Unveils EMMA™ Mainstream Capnograph for Enhanced Assessment of End-Tidal Carbon Dioxide
07/11/2013 French Society of Anaesthesia and Intensive Care Adds Masimo PVI® to Guidelines for Perioperative Hemodynamic Optimization
07/09/2013 The Joint Commission Issues National Patient Safety Goal and Requirements for Medical Device Alarm Management
06/19/2013 South Shore Hospital Standardizes to Masimo SET® Pulse Oximetry for Improved Patient Monitoring
06/11/2013 Masimo Signs Far-Reaching Pulse Oximetry Distribution Deal with Butler Schein Animal Health
06/06/2013 University Children's Hospital Basel Installs Masimo Patient SafetyNet™ System for Advanced Care and Oversight of General Ward Patients
06/03/2013 Masimo Announces Root™
05/30/2013 Masimo Renews $1,000,000 Guarantee that Masimo SET® Will Outperform All Covidien Nellcor™ Pulse Oximeters
05/23/2013 El Paso Children's Hospital Standardizes to Masimo SET® Pulse Oximetry
05/21/2013 Study Shows Noninvasive SpCO® Can Help Rapidly Detect Carbon Monoxide Poisoning in the Emergency Department
05/21/2013 Masimo CEO Joe Kiani Receives Argyros Medal for Visionary Leadership & Commitment to Patient Safety
05/16/2013 New Clinical Study Finds Masimo rainbow® Acoustic Monitoring™ Technology More Accurately, Precisely, and Reliably Detects Ventilatory Pauses in Post-Surgical Patients
05/15/2013 New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Pediatric Patients
05/13/2013 New Clinical Studies Presented at the International Anesthesia Research Society Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb®, RRa™, and SedLine®
05/08/2013 Uludag University Hospital Installs Masimo Noninvasive rainbow® Technology to Improve Patient Assessments and Speed Clinical Decisions
05/07/2013 FDA Clears Masimo rainbow® Acoustic Monitoring™ Sensor for Use on Pediatric Patients
05/02/2013 Masimo Reports First Quarter 2013 Financial Results
04/29/2013 Masimo iSpO2 Pulse Oximeter & EMMA Emergency Capnometer Earn JEMS Hot Products Awards
04/26/2013 Masimo Steps Up with March for Babies™ to Fight for Healthier Newborns
04/18/2013 Masimo to Report First Quarter 2013 Financial Results after Market Close on Thursday, May 2
04/05/2013 East Tennessee Children's Hospital Installs Masimo Patient SafetyNet™ System for Improved Oversight of Postoperative Patients
03/27/2013 Holland Hospital Installs Masimo Noninvasive rainbow® Technology to Help Improve Patient Assessments and Speed Clinical Decisions
03/20/2013 Hospital General Universitario Santa Lucia Is First in Spain to Install Masimo Patient SafetyNet™ System for Improved Oversight of its Neonatal Care Unit
03/07/2013 Masimo to Present at 25th Annual ROTH Conference
02/20/2013 University of Virginia Medical Center Installs Masimo Noninvasive rainbow® Technologies to Improve Patient Assessments and Speed Clinical Decisions
02/19/2013 Masimo to Present at Raymond James 34th Annual Institutional Investors Conference
02/15/2013 Masimo Continues Its Advocacy on Behalf of Newborns During Congenital Heart Defects (CHD) Awareness Week
02/14/2013 Masimo Announces Adoption of Stock Repurchase Program
02/14/2013 Masimo Reports Fourth Quarter and Full Year 2012 Financial Results; Provides 2013 Financial Guidance
01/30/2013 Libya Becomes First to Standardize Its Blood Donation Centers to Masimo Pronto-7® for Quick, Noninvasive Spot-Checking of Hemoglobin (SpHb®), SpO2, Pulse Rate, and Perfusion Index
01/30/2013 Masimo to Report Fourth Quarter and Full Year 2012 Financial Results after Market Close on Thursday, February 14
01/11/2013 Study Featuring Transfusion Impact of Masimo SpHb® Monitoring Receives 2013 Best Clinical Application of Technology Award at Society for Technology in Anesthesia Annual Meeting
01/10/2013 New Study Shows Masimo Noninvasive & Continuous Total Hemoglobin (SpHb®) Monitoring Significantly Reduces Blood Transfusions and Costs in High Blood Loss Surgery
01/03/2013 Masimo iSpO2™ Pulse Oximeter for iOS Platform (iPhone, iPad & iPod touch) for Consumers* to Debut at CES
12/27/2012 University of North Carolina Hospitals Standardizes to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
12/21/2012 Happy Holidays from Masimo!
12/19/2012 Ogden Regional Medical Center Standardizes to Masimo rainbow® Pulse CO-Oximetry™
12/18/2012 Masimo to Present at 31st Annual J.P. Morgan Healthcare Conference
12/13/2012 Masimo Launches iSpO2™ – Commercially Available Pulse Oximeter for iPhone, iPad & iPod touch
12/11/2012 Voting for the first REAL Awards is now open!
11/29/2012 Saint Mary's Healthcare Standardizes on Industry-Leading Masimo SET® Pulse Oximetry
11/27/2012 IWK Health Centre Standardizes to Masimo SET® Pulse Oximetry
11/20/2012 Masimo Corporation Founder and CEO Joe Kiani Named Ernst & Young National Entrepreneur Of The Year – 2012 Life Sciences Award Winner
11/15/2012 Maricopa Integrated Health System Installs Masimo Patient SafetyNet™ System for Improved Oversight of General Floor
11/12/2012 Trinity Medical Center Adds Masimo Patient SafetyNet™ as a High Vigilance Safeguard for Post-Surgical Patients
11/06/2012 Skagit Valley Hospital Standardizes on Masimo SET® Measure-Through Motion and Low Perfusion Pulse Oximetry
11/01/2012 Masimo Reports Third Quarter 2012 Financial Results; Board Declares Special Cash Dividend of $1.00 per Share
11/01/2012 Premier Signs SedLine® Supplier Agreement with Masimo
10/31/2012 Kennedy Health System Renews System-Wide Pulse Oximetry Contract with Masimo
10/30/2012 Masimo Reschedules Release of Third Quarter 2012 Financial Results and Associated Conference Call to Thursday, November 1st Due to Hurricane Sandy
10/25/2012 Alameda County Medical Center Deploys Masimo Patient SafetyNet™
10/24/2012 New Clinical Study Finds Pronto® Has Similar Accuracy to Commonly Used Point-of-Care Invasive Hemoglobin Analyzer
10/18/2012 Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb, PVI, RRa, and SEDLine
10/16/2012 Masimo to Report Third Quarter 2012 Financial Results after Market Close on October 30
10/15/2012 Masimo Initiates Limited Market Release of Universal ReSposable™ Pulse Oximetry Sensor System
10/12/2012 Masimo Unveils Fractional Arterial Oxygen Saturation, SpfO2, and rainbow SuperSensor
10/09/2012 GE Healthcare Integrates New FDA-Cleared Masimo SET® uSpO2™ Pulse Oximetry Cable into GE's ApexPro® Telemetry Systems
10/02/2012 Albany Medical Center Standardizes to Masimo rainbow SET Pulse CO-Oximetry®
10/01/2012 Hamilton Medical Center Updates with Masimo Patient Monitoring Technologies
09/25/2012 Masimo Announces $1 Million Commitment to Action with the Clinton Global Initiative to Solve Maternal Mortality & Anemia
09/24/2012 Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (CCHD)
09/21/2012 Joe Kiani Speaks at TEDx Conference
09/20/2012 Masimo Pronto-7® Wins GOLD "Stevie®" Award for Best New Health Product
09/19/2012 Inova Health System Re-Ups System-wide Pulse Oximetry Contract with Masimo
09/12/2012 Easton Hospital Adds Masimo Patient SafetyNet™ System and rainbow® Pulse CO-Oximetry for Noninvasive Patient Monitoring
09/10/2012 Masimo to Host Investor Day on September 20
09/04/2012 Phoenix Children's Hospital Standardizes on Masimo
08/28/2012 Princeton's University Medical Center Deploys Masimo Patient SafetyNet™
08/13/2012 Joint Commission Issues Sentinel Event Alert on Opioid-Induced Respiratory Depression
08/07/2012 Masimo's Noninvasive Pleth Variability Index as Accurate as Invasive Stroke Volume Variation for Fluid Responsiveness Assessment in Cardiac Surgery
08/01/2012 Masimo Reports Second Quarter 2012 Financial Results
08/01/2012 Masimo Enters Noninvasive Multigas Monitoring, including Capnography, with Acquisition of PHASEIN
07/26/2012 New Study Reveals Wide Variation in Blood Transfusion Practices During Surgery
07/23/2012 Masimo Signs Pulse Oximetry Distribution Deal with MWI Veterinary Supply
07/18/2012 Masimo to Report Second Quarter 2012 Financial Results after Market Close on August 1
07/17/2012 Pulse Oximetry Screening Hailed as the 'New Milestone' to Combat Critical Congenital Heart Disease - Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies
07/09/2012 New Study Affirms Masimo rainbow® Pulse CO-Oximetry™ Accuracy for Noninvasive Carboxyhemoglobin and Methemoglobin Measurements
07/03/2012 U.S. Medical Materiel Enterprise Standardization Office Selects Masimo Rad-57™ Handheld Pulse CO-Oximeter as Joint Product of Choice
07/02/2012 Masimo Signs Pronto-7™ Distribution Deal with PSS World Medical
06/25/2012 New Study Shows Masimo SET® Pulse Oximetry Outperforms Competing Technologies
06/21/2012 New Study Shows Masimo rainbow® Pulse CO-Oximetry™ Speeds Evaluation & Treatment of Carbon Monoxide Poisoning
06/18/2012 Anesthesia Patient Safety Foundation Publishes Expanded Dartmouth Hitchcock Medical Center Results with Post-Surgical Monitoring Using Masimo SET® and Patient SafetyNet™
06/13/2012 Masimo Signs Pronto-7™ Distribution Deal with Henry Schein
06/11/2012 United Kingdom's National Health Service Includes Masimo Pleth Variability Index® as "High Impact Innovation" for Intra Operative Fluid Management
06/08/2012 Masimo CEO Joe Kiani Named Ernst & Young Entrepreneur of the Year
06/04/2012 Premier Healthcare Renews Supplier Agreement with Masimo
05/31/2012 Masimo 2012 Radical-7® and Pronto-7™ Shine at Nursing Expo
05/29/2012 Masimo to Present at William Blair & Company 32nd Annual Growth Stock Conference
05/17/2012 First Published Study on Masimo Acoustic Respiration Rate Demonstrates Significantly Higher Patient Tolerance and Similar Accuracy Compared to Capnometry in Post-Surgical Patients
05/08/2012 Masimo Joins Summer Jobs+ Program, Offering Paid Internships, Free Workshops
05/08/2012 Ospedale Valduce and Masimo Announce Italy's First Installation of Masimo Patient SafetyNet™
05/03/2012 Novation Inks Supplier Contract Category Agreement for Masimo SET® pulse oximetry and rainbow® SET Pulse CO-Oximetry™
05/02/2012 Masimo Reports First Quarter 2012 Financial Results
04/26/2012 Masimo to Present at Deutsche Bank Securities 37th Annual Health Care Conference
04/25/2012 Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
04/23/2012 Essential Medical Dismisses Patent Case against Masimo and Cercacor
04/19/2012 New Study Shows Masimo's Noninvasive Pleth Variability Index Provides Similar Ability to Assess Fluid Responsiveness During Surgery as More Costly and Invasive Method
04/18/2012 Masimo to Report First Quarter 2012 Financial Results after Market Close on May 2
04/12/2012 Masimo Pronto-7™ Receives China and South Korea Regulatory Clearances
04/02/2012 Fortis Healthcare Signs Agreement Giving India's Fastest-Growing Hospital Chain Access to Masimo's State-of-the-Art Noninvasive Patient Monitoring Solutions
03/26/2012 Masimo Debuts 2012 Radical-7® at World Congress of Anaesthesiologists
03/12/2012 Masimo Acquires Assets of Spire Semiconductor to Advance Innovation, Speed Development, and Reduce Costs
03/06/2012 Sana Kliniken AG Signs Agreement with Masimo, Giving One of Germany's Largest Private Hospital Networks Access to Masimo's Advanced Noninvasive Patient Monitoring Solutions
02/27/2012 Masimo to Present at 24th Annual ROTH Conference
02/23/2012 GE Healthcare Partners with Masimo to Incorporate rainbow® SET Technology with GE Patient Monitors
02/14/2012 Masimo Announces "Better Care" Program—A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with
02/14/2012 Masimo Reports Fourth Quarter and Full Year 2011 Financial Results; Provides 2012 Financial Guidance
01/26/2012 Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012
01/09/2012 Masimo Announces FDA Clearance and Full Market Release of the New Pronto-7™ for Noninvasive Total Hemoglobin Spot-Check Measurement, Along with SpO2, Pulse Rate, and Perfusion Index
12/21/2011 Happy Holidays from Masimo!
12/20/2011 Masimo to Present at 30th Annual J.P. Morgan Healthcare Conference
12/13/2011 New Clinical Study Presented at the NYPGA Meeting Shows Respiration Rate Monitoring—Considered the Fourth Primary Vital Sign—Has Been Revolutionized With Masimo rainbow Acoustic Monitoring Technology
11/17/2011 Antelope Valley Hospital Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
11/15/2011 Masimo to Present at 23rd Annual Piper Jaffray Health Care Conference
11/10/2011 Shands Jacksonville Medical Center Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
11/08/2011 Masimo Awarded the American Association of Respiratory Cares 2011 Zenith Award
11/08/2011 Masimo to Present at Lazard Capital Markets Healthcare Conference
10/25/2011 Masimo Reports Third Quarter 2011 Financial Results
10/24/2011 Guangdong Biolight Meditech Co., Ltd. Announces the Launch of Its Modular Patient Monitors with Masimo rainbow SET Pulse CO-Oximetry Technology
10/19/2011 New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Noninvasive Technologies: SpHb, PVI, RRa, and SEDLine
10/14/2011 Masimo to Report Third Quarter 2011 Financial Results after Market Close on October 25, 2011
10/13/2011 Masimo Launches the 2011 Radical-7 with rainbow® Acoustic Monitoring and In Vivo Adjustment™
10/10/2011 Masimo Rainbow Acoustic Monitoring Technology Cleared for Market in Japan
09/30/2011 Masimo Achieves New Milestone-Ships One Millionth Oximeter
09/29/2011 Published Study Demonstrates the Absolute and Trend Accuracy of Masimo Noninvasive and Continuous Total Hemoglobin (SpHb) Monitoring inIntensive Care Unit Patients
09/23/2011 U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard
09/12/2011 Centre Hospitalier de Chaumont in France Implements State-of-the-Art Remote Monitoring System to Advance Patient Safety
08/31/2011 Shriners Hospitals for Children® - Honolulu: First in Hawaii to Implement Masimo Noninvasive Hemoglobin Monitoring Technology
08/29/2011 Masimo Pronto-7™ Receives Japanese and Canadian Regulatory Clearances
08/29/2011 Masimo to Present at Morgan Stanley Global Healthcare Conference
08/24/2011 Masimo Obtains CE Mark for SEDLine, Launches EEG-Based Brain Function Monitors in European Market
08/09/2011 Masimo Announces Adoption of Stock Repurchase Program
08/09/2011 Masimo Reports Second Quarter 2011 Financial Results Q2 2011 Highlights (compared to Q2 2010):
08/08/2011 Masimo Introduces Pronto-7™ Internationally and Lifts Voluntary Recall
07/19/2011 Masimo to Report Second Quarter 2011 Financial Results after Market Close on August 9, 2011
06/27/2011 Masimo and Dartmouth-Hitchcock Medical Center, First Cross-Industry Collaborative Honored with the Institute for Technology and Healthcare Clinical Application Award
06/16/2011 New Clinical Research Presented at the European Society of Demonstrates the Accuracy and Utility of Masimo SpHb and PVI
06/15/2011 Masimo Announces Rainbow Agreement with Philips
06/09/2011 Masimo Pronto-7 Wins GOLD in the 2011 Medical Design Excellence Award Competition—the Premier Awards Program for the Medical Technology Community
06/03/2011 Masimo to Present at William Blair & Company 31st Annual Growth Stock Conference
06/02/2011 Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring
05/26/2011 Masimo to Present at Goldman Sachs 32nd Annual Global Healthcare Conference
05/19/2011 Masimo Launches MS-2040, First Sub-45 mW Signal Extraction Pulse Oximetry Platform
05/16/2011 New Published Study Demonstrates the Accuracy of Masimo Noninvasive and Continuous Hemoglobin Monitoring in Patients in Surgery and Intensive Care
05/03/2011 Masimo Reports First Quarter 2011 Financial Results
04/28/2011 Masimo Launches New Reusable SpCO® Sensor with Improved Accuracy and Reliability in Low Oxygen Saturation and Elevated Methemoglobin States
04/27/2011 Masimo to Present at the 2011 Bank of America Merrill Lynch Health Care Conference
04/21/2011 New Published Study Finds Masimo Noninvasive SpCO Effective for Screening Emergency Department Patients for Carbon Monoxide Poisoning
04/19/2011 Masimo to Report First Quarter 2011 Financial Results after Market Close on May 3, 2011
04/11/2011 New Published Study Finds Masimo SET® Delivers More Reliable Measurements Significantly Faster Than Other Pulse Oximetry Technologies
03/28/2011 Newtech, Inc., a Leading Chinese EMS Patient Monitoring Company, Partners with Masimo to Incorporate rainbow® SET Noninvasive Measurement Capabilities into New Patient Monitors
03/24/2011 New Studies Show Clinical Advantages of Masimo Noninvasive Hemoglobin, PVI, and Perfusion Index in Critically-ill Patients
03/03/2011 Masimo to Present at the Roth Growth Stock Conference
02/24/2011 Royal Fornia Medical Equipment Co., Ltd. Signs Technology Licensing Agreement to Integrate Masimo rainbow SET Pulse CO-Oximetry into New Patient Monitors
02/22/2011 Masimo to Present at the Cowen and Company Health Care Conference
02/21/2011 Mater Children's Hospital in Australia Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
02/15/2011 Masimo Reports Fourth Quarter and Full Year 2010 Financial Results; Provides 2011 Guidance
02/10/2011 Mafraq Hospital Becomes First in United Arab Emirates to Deploy Masimo rainbow SET Pulse CO-Oximetry for State-of-the-Art Noninvasive Patient Monitoring
02/08/2011 Welch Allyn Establishes Strategic Partnership to Incorporate Masimo rainbow® SET Noninvasive Measurement Capabilities in Next-Generation Patient Monitors
02/01/2011 New Published Study Finds Noninvasive Masimo PVI Accurately Predicts Fluid Responsiveness in Intensive Care Patients
01/31/2011 Masimo Provides Additional Comments Regarding Amendment to Settlement Agreement with Covidien
01/31/2011 Masimo and Covidien Announce Extension of Royalty Agreement
01/28/2011 Masimo to Report Fourth Quarter and Full Year 2010 Financial Results after Market Close on February 15, 2011
01/20/2011 New Clinical Study Finds Masimo Noninvasive Hemoglobin Accurate in Patients with Critically Low Hemoglobin Levels
01/18/2011 New Johns Hopkins School of Medicine Study Shows Masimo Noninvasive Hemoglobin Monitoring is Accurate During Complex Spine Surgeries

 

New Study Investigates the Performance of Masimo SpHb® During Acute Bleeding and After Fluid Resuscitation

Neuchatel, Switzerland – March 12, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Cairo University in Egypt evaluated the accuracy and trending of Masimo noninvasive and continuous hemoglobin (SpHb®), referenced to an invasive laboratory hemoglobin (Lab-Hb) measurement, during acute bleeding and after fluid resuscitation.1

Masimo Radical-7 with SpHb, PVi, and RD rainbow SET Sensor

Masimo Radical-7® with SpHb®, PVi®, and RD rainbow SET™ Sensor

In the study, Dr. Adel and colleagues sought to investigate the performance of SpHb in different volume statuses and perfusion states. They utilized intraoperative data from 70 patients scheduled for major orthopedic procedures with anticipated major blood loss. SpHb, as well as Masimo PVi® and Pi, were measured using a Masimo Radical-7® Pulse CO-Oximeter®. Lab-Hb was measured using a Beckman Coulter LH 750 analyzer. SpHb and Lab-Hb were recorded at three times – a baseline reading five minutes after endotracheal intubation, after major bleeding, and after fluid resuscitation – resulting in 210 time-matched readings, which were divided into fluid responsive and fluid non-responsive samples and low and high perfusion index samples.

Using Bland-Altman analysis, the researchers found "excellent correlation" between Lab-Hb and SpHb (r=0.938). In addition, they reported "excellent accuracy with moderate levels of agreement," as noted below, for various sample sets:

Sample set Mean bias Limits of agreement
All 0.01 -1.33 to 1.34 g/dL
Fluid non-responsive -0.08 -1.27 to 1.11 g/dL
Fluid responsive 0.09 -1.36 to 1.54 g/dL
High Pi 0.01 -1.34 to 1.31 g/dL
Low Pi 0.04 -1.31 to 1.39 g/dL

The researchers also noted that polar plot analysis (angular bias of -4) showed "good trending ability for SpHb as a follow-up monitor."

The investigators concluded that, "SpHb showed excellent correlation with Lab-Hb in fluid responders, fluid non-responders, low-Pi, and high-Pi states. Despite a favorable mean bias of 0.01 g/dL for SpHb, the relatively wide levels of agreement (-1.3 to 1.3 g/dL) might limit its accuracy. SpHb showed good performance as a trend monitor."

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@MasimoInnovates || #Masimo

Reference
1. Adel A, Awada W, Abdelhamid B, Omar H, Dayem O, Hasanin A, and Rady A. Accuracy and trending of noninvasive hemoglobin measurement during different volume and perfusion statuses. J Clin Mon. 2018. https://doi.org/10.1007/s10877-018-0101-z.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Replica™

Replica Allows Clinicians to Remotely Monitor Patients from Anywhere in Real Time

Las Vegas, Nevada – March 6, 2018 – Today at the 2018 HIMSS Annual Conference Masimo (NASDAQ: MASI) announced the release of Replica™, an application for smart phones and tablets that works in conjunction with Masimo Patient SafetyNet™*, a supplemental remote monitoring and clinician notification system. Replica allows clinicians to view continuous monitoring data for multiple patients, as well as view and respond to alarms and alerts, all from their smart phones, regardless of location.

With Patient SafetyNet, continuous monitoring data are available at a central viewing station. Replica builds on this capability by delivering continuous monitoring data and intelligent alarm notifications to remote clinicians on smart phones. Replica displays data relayed from connected bedside Masimo and third-party devices, such as ventilators and patient monitors. Replica also allows the display of high fidelity data, such as waveforms, in real time. Clinicians can also access up to 96 hours of historical data, aiding assessment of potential deterioration over time. The collation of data from multiple disparate sources in a single location provides clinicians with a more complete picture of patient status at a glance.

Masimo Replica

Masimo Replica™

Replica features intelligent two-way alarm and alert notification technology, derived from Patient SafetyNet's existing capabilities, that offers significant advantages over systems which send out rudimentary, one-way notifications. Replica extends Patient SafetyNet's intelligence by routing and escalating detailed, color-coded alarm and alert notifications to active mobile devices, reaching on-duty and available clinicians. Clinicians can respond to notifications from the app – choosing to accept or forward – and see if other clinicians have already responded. By combining detailed monitoring data with intelligent notification, Replica helps to improve clinical collaboration, promoting informed, timely response and effective clinical coordination.

Joe Kiani, Founder and CEO of Masimo, said, "Given the high patient-to-clinician ratios common in many areas, such as the medical-surgical floor, there is an increasing need for continuous remote visibility into patient status. Patient SafetyNet, combined with the power of SET® pulse oximetry, has been shown to save lives, reduce rapid response activations, and reduce costs in post-surgical wards.1-3 Replica takes the benefits of Patient SafetyNet to a new level by intelligently and reliably delivering valuable patient data and notifications to clinicians wherever they may be – thus helping them to respond and intervene as effectively and efficiently as possible."

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
2. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
3. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Replica™ and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Replica and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Leading Nephrology Care Center in India Adopts Masimo Technologies
Across Continuum of Care

Bangalore, India – February 26, 2018 – Masimo (NASDAQ: MASI) announced today that NU Hospitals, a leading nephrology care center in India, has standardized on Masimo technologies across the continuum of care. NU Hospitals have entered into a strategic partnership with Masimo to adopt technologies in their operating rooms (ORs), intensive care units (ICUs), dialysis beds, and general wards at both of their facilities in Bangalore.

"We have been evaluating various technologies that could help our clinicians improve patient safety and at the same time help reduce the cost of care. Masimo, with its innovative range of solutions – including remote monitoring systems, depth of sedation monitoring, and noninvasive monitoring of hemoglobin and fluid responsiveness – will help us accomplish these twin objectives," said Dr. Prasanna Venkatesh, Pediatric Urologist & Managing Director, NU Hospitals.

NU Hospitals' ORs will be equipped with Masimo Root® Patient Monitoring and Connectivity Hubs and Radical-7® Pulse CO-Oximeters®. The monitors will include noninvasive, continuous hemoglobin monitoring (SpHb®), a Masimo rainbow® parameter, and, via Masimo Open Connect® (MOC-9®) technology, SedLine® brain function monitoring.

In critical care areas and general wards, patients at NU Hospitals will now also be continuously monitored using a variety of bedside devices such as Root with Noninvasive Blood Pressure and Temperature and Rad-97™ Pulse CO-Oximeters. Measurements will include SpHb, SET® Measure-through Motion and Low Perfusion™ pulse oximetry, vital signs such as blood pressure and temperature, and, for dialysis patients, pleth variability index (PVi®) monitoring to assist in optimizing fluid management.

The bedside devices will be connected to Masimo Patient SafetyNet™*, a supplemental remote monitoring and clinician notification system which allows patient monitoring data to be accessed from a central viewing station. When changes occur in measured values that may indicate deterioration in a patient's condition, Patient SafetyNet automatically sends wireless alerts directly to clinicians, wherever they may be, allowing clinicians to respond quickly to patients in potential distress. In addition, Patient SafetyNet will automate the transfer of patient data, including vital signs, early warning scores (EWS), and other physiological parameters, directly to NU Hospitals' electronic medical record (EMR) system.

Dr. Venkatesh Krishnamoorthy, Chairman and Sr. Consultant Urologist, NU Hospitals, commented, "We believe that every hospital patient should be continuously monitored. The automatic integration of data into our EMR and reduction in the manual recording of patient vitals will help us reduce transcription errors, build efficiency, and improve workflow."

"We are excited to work with NU Hospitals and help them take better care of their patients with our advanced monitoring technologies," said Jon Coleman, President of Worldwide Sales, Professional Services, and Medical Affairs, Masimo. "We applaud NU Hospitals for advancing the standard of care in their region."

Bharat Monteiro, Country Manager for Masimo in India, added, "We are hopeful that more hospitals in India will adopt such advanced technologies across the continuum of care to help improve patient safety and reduce the cost of care."

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Masimo Root®, Radical-7®, SpHb®, MOC-9®, SedLine®, Rad-97™, SET®, PVi®, and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, Radical-7, SpHb, MOC-9, SedLine, Rad-97, SET®, PVi, and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates the Performance of Masimo SpHb® in Monitoring
Pediatric Trauma Patients

Irvine, California – February 22, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Michigan State University evaluated the performance of noninvasive hemodynamic monitoring (NIHM) using Masimo noninvasive and continuous hemoglobin (SpHb®), as compared to invasive laboratory hemoglobin (LabHb) monitoring, in clinically stable pediatric trauma patients with solid organ injury.1

In the study, Dr. Welker and colleagues utilized data from 21 patients under 18 years of age who had experienced blunt trauma, with a mean injury severity score of 16.6. Their hemodynamic status was assessed using physical examination and vital signs in conjunction with periodic LabHb monitoring per normal institutional pediatric trauma guidelines. In addition, NIHM using Masimo SpHb was measured continuously using a Masimo Radical-7® Pulse CO-Oximeter®, and SpHb values were recorded at multiple times to correspond with LabHb blood draws.

Masimo Radical-7 with SpHb

Masimo Radical-7® with SpHb®

Using Bland-Altman analysis, the researchers calculated an average bias of 0.80 g/dL between SpHb and LabHb, with a 95% confidence interval of +3.94 g/dL to -2.33 g/dL. They noted that, "Measurement trends were highly correlated in patients with stable hemoglobin levels and those requiring blood transfusion."

The investigators concluded that, "NIHM demonstrated clinically acceptable accuracy when following hemoglobin trends in the defined pediatric trend patient population. Slight variances between NIHM and LabHb values were occasionally noted, but did not affect clinical management. Continuous NIHM represents a potentially valuable adjunct to traditional laboratory hemoglobin monitoring."

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@MasimoInnovates || #Masimo

Reference
1. Welker E, Novak J, Jelsma L, Koehler T, Davis A, DeCou J, and Durkin E. Continuous hemoglobin monitoring in pediatric trauma patients with solid organ injury. J Pediatr Surg. 2018. https://doi.org/10.1016/j.jpedsurg.2017.12.015.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates the Performance of Masimo PVi® as a Predictor of Fluid Responsiveness in Mechanically Ventilated ICU Patients

Neuchatel, Switzerland – February 12, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Bülent Ecevit University in Zonguldak, Turkey compared two noninvasive methods of predicting fluid responsiveness in mechanically ventilated patients in the intensive care unit (ICU): Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) and dIVC (distensibility index of inferior vena cava, measured noninvasively by radiologists using an ultrasound machine and probe).1

In the study, Drs. Pişkin and z sought to compare the performance of the two methods by enrolling 72 mechanically ventilated patients and taking various measurements before and after passive leg raising (PLR). In addition to PVi (measured with Masimo Radical-7® Pulse CO-Oximeters®) and dIVC (measured by a radiologist using Esaote MyLab 30), central venous pressure (CVP) and cardiac index (CI) were measured. Patients who exhibited a greater than 15% increase in CI attributable to the PLR maneuver were classified as volume responders, and those with less than 15% or no change, as nonresponders.

Masimo Radical-7 with PVi

Masimo Radical-7® with PVi®

The researchers found that Masimo noninvasive and continuous PVi, at a threshold value of >14%, provided 95% sensitivity and 81.2% specificity (p<0.001, AUC = 0.939 (0.857-0.982)), which was statistically significant. Ultrasound, noninvasive dIVC, at a threshold value of >23.8%, provided 80% sensitivity and 87.5% specificity (p<0.001, AUC = 0.928 (0.842-0.975)), which was also statistically significant. The invasive method, CVP, at a threshold value of ≤7 mmHg, provided 70% sensitivity and 53.1% specificity to predict fluid responsiveness (p=0.066, Area Under the Curve = 0.622 (0.500-0.724)), which was not statistically significant.

The investigators noted that "our results show that noninvasively assessed PVi and dIVC were good predictors of fluid responsiveness after PLR in ICU patients on mechanical ventilation. By contrast, the invasively assessed CVP was a poor predictor of fluid responsiveness as a static variable of cardiac preload." They concluded that, "Both PVi and dIVC may be used to identify the fluid responsiveness of all ICU patients undergoing continuous treatment linked to mechanical ventilation; both methods are easily applied, noninvasive, and can be performed at the bedside."

@MasimoInnovates || #Masimo

Reference
1. Pişkin and z I. Accuracy of pleth variability index compared with inferior vena cava diameter to predict fluid responsiveness in mechanically ventilated patients. Medicine. (2017) 96:47(e8889).

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Eve™ CCHD Newborn Screening Application for the Rad-97™ Pulse CO-Oximeter®

Neuchatel, Switzerland – February 7, 2018 – Masimo (NASDAQ: MASI) announced today the CE marking of Eve™, a critical congenital heart disease (CCHD) newborn screening application, for the Rad-97™ Pulse CO-Oximeter®. Eve combines the power of Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry with a pre-ductal to post-ductal synchronization algorithm designed to reduce calculation errors.

Eve, also available on the Radical-7® Pulse CO-Oximeter, simplifies the CCHD screening process by providing visual instructions, animations, an automatic synchronization algorithm, and a detailed, easy-to-interpret display of screening results. The ability to label results with unique patient identifiers for both mother and newborn facilitates intuitive session management and seamless electronic charting. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion.1

Masimo Rad-97 with Eve

Masimo Rad-97™ with Eve™

CCHD affects approximately 3 newborns per 1000 live births2 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.3 In a study of 39,821 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and Masimo SET® pulse oximetry.4 In a study of 122,738 infants – the largest CCHD screening study to date – CCHD screening sensitivity increased from 77% to 93% with the combined use of Masimo SET® and clinical assessment.5

"Multiple studies have shown that Masimo SET® pulse oximetry can help improve CCHD screening, helping to save many newborns' lives while reducing the cost of care," commented Joe Kiani, Founder and CEO of Masimo. "Eve builds on the powerful benefits of SET® by transforming pulse oximeters into intuitive screening tools which can help clinicians perform the crucial work of screening newborns in an easy-to-follow and intuitive application."

Eve has not obtained FDA clearance and is not available in the United States. Radical-7 and Rad-97 have obtained FDA clearance and are available, without Eve, in the United States.

@MasimoInnovates || #Masimo

References
1. de-Wahl Ganelli et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr. 2007 Oct;96(10):1455-1459.
2. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
3. 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygience, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implmentation of Screening for Critical Congenital Hearth Disease in Newborns. Page 7.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
5. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET®, Eve™, Rad-97™, and Radical-7®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET®, Eve, Rad-97, and Radical-7, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Report Fourth Quarter and Full Year 2017 Financial Results after Market Close on Tuesday, February 27

IRVINE, Calif, January 30, 2018 – Masimo (NASDAQ: MASI) announced today that it will release fourth quarter and full year 2017 financial results for the period ended December 30, 2017, after the market closes on Tuesday, February 27, 2018. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Micah Young, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 9789137. After the live webcast, the call will be available on Masimo's website through March 27, 2018. In addition, a telephonic replay of the call will be available through March 6, 2018. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 9789137.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com.

Investor Contact:
Eli Kammerman
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:
Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA Clearance of Next Generation SedLine®
Brain Function Monitoring

Irvine, California – January 29, 2018 – Masimo (NASDAQ: MASI) announced today FDA clearance of Next Generation SedLine® brain function monitoring. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral acquisition and processing of four leads of electroencephalogram (EEG) signals. Next Generation SedLine features an enhanced signal processing engine, driving a variety of performance improvements and helping give clinicians a more complete picture of the brain.

Next Generation SedLine provides an enhanced Patient State Index (PSi) – a processed EEG parameter related to the effect of anesthetic agents – based on its enhanced signal processing engine.

Masimo Root with Next Generation SedLine Brain Function Monitoring

Masimo Root® with Next Generation SedLine® Brain Function Monitoring

In addition, Next Generation SedLine displays an enhanced, Multitaper Density Spectral Array (DSA), developed by Dr. Emery Brown, MD, PhD, and Dr. Patrick Purdon, PhD, Director and Associate Director, respectively, of the Neuroscience Statistics Research Lab at Massachusetts General Hospital. The DSA represents activity in both sides of the brain. When displaying a Multitaper DSA, EEG data are transformed into the frequency domain, and may provide a better display of EEG features.

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is committed to innovation in the brain function monitoring space. With the improved performance offered by its enhanced signal processing capabilities, we expect Next Generation SedLine to impact brain function monitoring just as SET® impacted pulse oximetry."

When used with the RD SedLine™ EEG sensor, Next Generation SedLine can be used simultaneously with O3® regional oximetry on the Root® patient monitoring and connectivity platform for even more insight into a patient's brain. O3 may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Next Generation SedLine® and O3®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Next Generation SedLine and O3, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™, in Obese Patients

Neuchatel, Switzerland – January 22, 2018 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the annual meeting of the Society for Technology in Anesthesia (STA) in Miami, Florida. In the study, researchers at the UC Davis School of Medicine evaluated the potential clinical utility of Masimo Oxygen Reserve Index™ (ORi™) as an early warning of impending arterial hemoglobin desaturation in obese patients.1 This is the first published research investigating the utility of ORi in this particular population group.

ORi is a relative indicator of a patient's oxygen reserve in the moderate hyperoxic region (partial pressure of oxygen in arterial blood [PaO2] in the range of 100 to 200 mmHg). As an "index" parameter with a unit-less scale between 0 and 1, ORi can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen reserve.

In the prospective, observational study, Dr. Ayala and colleagues analyzed data from 36 adult patients with BMI between 30 and 40 kg/m2 who were scheduled for elective surgical procedures requiring general anesthesia and endotracheal intubation. The patients' ORi values were measured using a Masimo Root® Patient Monitoring and Connectivity Platform with Radical-7® Pulse CO-Oximeter®. The researchers recorded the time elapsed from the start of ORi alarming (triggered by decrease in the absolute value and rate of change in ORi) to 98% oxygen saturation, and considered this interval to be the average increase in warning time provided by ORi.

The researchers found that among the patients, the average time from the start of ORi alarming to 98% oxygen saturation was 42 ± 49 seconds (ranging from 5 to 255 seconds). Excluding two outliers, the average increase in warning time provided by ORi was 33 ± 23 seconds (ranging from 5 to 107 seconds).

The researchers concluded that the study "demonstrates the ability of ORi to provide advanced warning of arterial desaturation as an adjunct to SpO2 in this high risk patient population. This additional warning time can potentially translate to improved patient safety by allowing earlier calls for help, assistance from a more experienced person, or modification of airway management. For this analysis we defined the advance warning to end at 98% SpO2, with a defined trigger for intervention at 94% SpO2."

In another study, researchers at Children's Medical Center in Dallas, Texas concluded that ORi could provide clinicians with a median of 31.5 seconds advanced warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation.2

UC Davis received funding from Masimo for the ORi study.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Ayala S, Singh A, Applegate R, and Fleming N. Oxygen Reserve Index: Utility as Early Warning of Desaturation in Morbidly Obese Patients. Proceedings from the 2018 STA Annual Meeting, Miami, FL.
2. Szmuk P et al. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve–A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo ORi™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo ORi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA Clearance for Home Use of Rad-97™

Rad-97 Comes with Advanced Communication Capabilities to Facilitate Telehealth

Irvine, California – January 9, 2018 – Masimo (NASDAQ: MASI) announced today FDA clearance for home use of the Rad-97™ Pulse CO-Oximeter®. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion™ SET® pulse oximetry and upgradeable rainbow® technologies, in a compact, standalone monitor that combines advanced connectivity and communication capabilities for telehealth with an interface easily customized for use at home.

Masimo Rad-97 Pulse CO-Oximeter with Optional Integrated Camera

Masimo Rad-97 Pulse CO-Oximeter with Optional Integrated Camera

With an ever increasing number of patients receiving care at home, there is a growing need for high-quality home monitoring and telehealth equipment. Rad-97, in addition to SET® pulse oximetry and advanced parameter monitoring technology through rainbow® noninvasive monitoring, is available with optional integrated blood pressure and capnography measurements. Its innovative communication capabilities allow monitoring data from a variety of third-party Bluetooth®-enabled devices used at home, including thermometers, weight scales, and glucometers, to seamlessly transfer to Rad-97 – and from there to anywhere in the world, in real time. The optional integrated camera allows remote clinicians to interact with patients over live audio and video. Rad-97 brings hospital-grade technology to the home in a single, integrated device that is a monitoring, connectivity, and telecommunications hub.

Patient surveillance using Masimo Patient SafetyNet

Patient surveillance using Masimo Patient SafetyNet

With its built-in enterprise WiFi capability, Rad-97 has the ability to connect wirelessly from the home to supplemental patient monitoring systems in the hospital, including Masimo Patient SafetyNet™*, allowing clinicians to remotely observe patient status while facilitating automatic data transfer to hospital electronic medical record (EMR) systems. Rad-97 can trend and store data for up to 96 hours.

With its intuitive touchscreen interface, Rad-97 is easy to use for clinicians and non-clinicians alike, and can be easily customized to meet the needs of home users. The device can be configured in Home mode, which streamlines basic utility, giving home users access to applicable settings and messages, while hiding others and locking alarm settings, minimizing the chances of inadvertent interaction.

Joe Kiani, Founder and CEO of Masimo, said, "Rad-97 is well-suited for a variety of care settings, now including home. Facilitated by its powerful connectivity and telehealth capabilities, Rad-97 allows clinicians to remotely interact with patients, as well as monitor their status and spot trends from afar through automated data collection and transfer."

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-97™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking and Release of Oxygen Reserve Index™
rainbow Lite Sensors

Neuchatel, Switzerland – January 2, 2018 – Masimo (NASDAQ: MASI) announced today the CE marking and release of RD rainbow Lite SET™ sensors, which enable the monitoring of Masimo Oxygen Reserve Index™ (ORi™) and RPVi™, an improved PVi® that allows clinicians to assess fluid responsiveness noninvasively and continuously1 at a fraction of the cost of invasive methods, and at a fraction of the cost of rainbow® sensors. rainbow Lite sensors utilize twice as many wavelengths of light as SET® sensors, allowing rainbow Lite sensors to provide ORi and RPVi along with Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.

Masimo RD rainbow Lite SET™ Sensor

ORi is the first noninvasive and continuous parameter to provide insight into a patient's oxygen reserve in the moderate hyperoxic range. In conjunction with SET® pulse oximetry, ORi may provide advanced warning of impending desaturation, which may allow clinicians to intervene sooner. For example, in a study of 25 pediatric patients undergoing general anesthesia with orotracheal intubation, researchers found that ORi helped clinicians identify impending desaturation a median of 31.5 seconds before noticeable changes in oxygen saturation (SpO2) occurred.2 In another recent study of 106 adult patients scheduled for surgery with arterial catheterization and intraoperative blood gases analyses, researchers found a significant relationship between change in PaO2 and change in ORi.3 In addition, ORi may provide insight into oxygen reserve when titrating patients who are receiving supplemental oxygen.4

Joe Kiani, Founder and CEO of Masimo, said, "rainbow Lite sensors allow clinicians, who depend on powerful SET® pulse oximetry technology, to augment their patient monitoring with ORi and newly introduced RPVi. Given the positive reception of ORi in available markets, and feedback from clinicians who see great value in the benefits of ORi monitoring, we are excited to make ORi and RPVi accessible via the cost-effective solution represented by RD rainbow Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay only nominally more per sensor than for SET®."

Masimo RPVi is a multi-wavelength version of Pleth Variability Index (PVi). RPVi is designed to provide enhanced assessment of changes in fluid volume compared to PVi5, which has been shown in over 90 independent clinical studies to be as effective as invasive monitoring methods.6

With the addition of RD rainbow Lite SET, the RD family of sensors is now available in three levels of capability: RD SET, utilizing two wavelengths (2 LED) and featuring SET® pulse oximetry; RD rainbow Lite SET, which utilizes four wavelengths (4 LED) and adds the ability to measure ORi and RPVi; and RD rainbow SET, which utilizes over seven wavelengths (7+ LED) and enables the measurement of additional advanced noninvasive parameters such as SpHb® (total hemoglobin), SpCO® (carboxyhemoglobin), SpMet® (methemoglobin), and SpOC™ (oxygen content).

Like RD SET sensors, RD rainbow Lite SET sensors are designed to maximize patient comfort and optimize clinician workflow. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient's hand or foot. The sensors feature an intuitive sensor-to-cable connection, with tactile and audible feedback to ensure a proper connection, and have graphics printed on both sides to assist with application.

Devices with ORi and RPVi measurements and RD rainbow Lite SET sensors have not received FDA 510(k) clearance and are not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct;111(4):910-4.
2. Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, and Ezri T. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.
3. Applegate R, Dorotta I, Wells B, Juma D, and Applegate P. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep; 123(3); 626-633.
4. Scheeren TWL, Belda FJ and Perel A. The oxygen reserve index (ORi): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2017. doi:10.1007/s10877-017-0049-4.
5. Masimo data on file.
6. Published clinical studies on PVi can be found at www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo RD rainbow Lite SET™ sensors, ORi™, RPVi™, and PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo RD rainbow Lite sensors, ORi, RPVi, and PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Artemis Hospital Becomes First in India to Adopt Masimo Patient SafetyNet™ Across All Hospital Care Areas

Supplemental Patient Surveillance System, in Conjunction with Masimo SET® and rainbow® Monitors, Provides Continuous Remote Monitoring 24 Hours a Day

Gurgaon, India – December 1, 2017 – Masimo (NASDAQ: MASI) announced today that Artemis Hospital, one of the leading multi-specialty hospitals in the Delhi-NCR region of India, is adopting Masimo Patient SafetyNet™*, a supplemental remote monitoring and clinician notification system, across all hospital care areas.

Patient SafetyNet, in conjunction with Masimo SET® pulse oximetry and rainbow® pulse CO-oximetry, will enable the hospital team to monitor key patient parameters and gain insight, via changes in patient status recorded by Masimo bedside monitors, into possible signs of patient deterioration. Artemis is the first hospital in India to offer such round-the-clock patient surveillance across all specialties. With Patient SafetyNet, Artemis hopes to achieve results similar to those achieved at Dartmouth-Hitchcock Medical Center in the United States: In 2016, the Medical Center, which had been using Masimo SET® pulse oximetry and Patient SafetyNet as part of a comprehensive alarm management strategy in all medical-surgical units for ten years, reported achieving a 50% reduction in unplanned ICU transfers and a 60% reduction in rescue events over those ten years, despite increases in patient acuity and occupany.1,2

"Artemis is renowned for its patient-centric care and we wanted to further augment it using technologies that can continuously monitor patients across different care areas," said Dr. Devlina Chakravarty, Executive Director of Artemis Hospitals. "Given our stringent standards for quality and state-of-the-art infrastructure, Patient SafetyNet was a natural fit."

Patient SafetyNet allows clinicians at a central station to review patient data continuously relayed from bedside monitoring devices. It also features a robust supplemental alarm notification and escalation process that relays notifications to clinicians wherever they may be in the hospital. If notifications remain unacknowledged, they are escalated to additional clinicians per a customizable protocol.

Dr. (Col.) Manjinder Singh Sandhu, Medical Director and Director-Cardiology, Artemis Hospitals, said, "Artemis has always been ahead of the industry in adopting initiatives and technologies that can improve patient care. Continuous supplemental remote monitoring in areas not usually monitored is one such initiative and we wanted a solution that can seamlessly integrate with our existing protocols and infrastructure. We found Masimo Patient SafetyNet to be one such system that offered both unmatched value and hassle-free integration."

Jon Coleman, President of Worldwide Sales, Professional Services, and Medical Affairs, Masimo, said, "Artemis is leading the way for patient safety in India with their commitment to monitor all of their patients all of the time. Continuous remote monitoring with SET® technology saves lives and precious resources. We are delighted to serve Artemis Hospital with our technology."

Bharat Monteiro, Country Manager, India and ISC, for Masimo, added, "We are in the process of altering the landscape of continuous and remote monitoring in India with our customized product offerings and unique value proposition. Masimo and Artemis share a commitment to patient care and we are excited to work with the Artemis team to help make a difference in care and satisfaction of their patients and clinicians."

Artemis care areas will be equipped with bedside monitoring devices such as the Radius-7® Pulse CO-Oximeter®, a Bluetooth- and WiFi-enabled wearable, tetherless monitor used in conjunction with the Root® Patient Monitoring and Connectivity Platform, as well as Rad-97™, Masimo's most recent bedside pulse CO-oximeter. These devices feature SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology to measure oxygen saturation, pulse rate, and perfusion index for all patients, with fewer of the false alarms3 that have made monitoring patients in less nurse-intensive areas impractical. A subset of patients will also be monitored using SpHb®, a Masimo rainbow® parameter that measures hemoglobin, continuously and noninvasively. Each floor will also use a cart-mounted Root with Noninvasive Integrated Blood Pressure and Temperature monitor to provide periodic spot-checking of vital signs and input for automated Early Warning Scores, built into Root. Patient data from all of these devices, in addition to being relayed to Patient SafetyNet, will be automatically integrated with the hospital's electronic medical record (EMR) and hospital information system (HIS).

Artemis Hospital, established in 2007, is a 380-bed, state-of-the-art multi-specialty hospital located in Gurgaon, India, the first in Gurgaon to be accredited by the Joint Commission International (JCI) and the National Accreditation Board for Hospitals and Healthcare Providers (NABH).

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
2. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
3. Shah N et al. Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers. J Clin Anesth. 2012 Aug;24(5):385-91.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA Clearance and Worldwide Release of NomoLine™ Capnography Sampling Lines

Includes U.S. Release of NomoLine Airway Adapter Sets for Neonatal and Infant Patients

Irvine, California – November 27, 2017 – Masimo (NASDAQ: MASI) announced today FDA clearance and U.S. release of the full family of NomoLine™ capnography sampling lines. NomoLine sampling lines are available in more than 40 configurations of airway adapter sets and cannulas for use in a variety of clinical scenarios, including for intubated and non-intubated patients in both low and high humidity applications, for all patient populations, including neonatal patients. NomoLine capnography sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors and enable hassle-free sidestream capnography and gas monitoring.

Masimo Root® Patient Monitoring and Connectivity Platform with NomoLine™ Capnography

NomoLine "no moisture" sampling technology eliminates many common problems associated with conventional sidestream gas sampling line systems. Incorporating a unique, patented polymer, NomoLine allows water in the sampling line to continuously evaporate into the surrounding air, while leaving oxygen, carbon dioxide, and anesthetic gases unaffected. This technology eliminates the need for water traps and issues related to their handling, as well as enabling extended monitoring time in high humidity applications, reducing the volume of disposables and the cost and waste associated with them.

NomoLine technology is designed for low-flow applications, with a very low sampling rate of 50 ml/min, supporting use on patients with low tidal volumes and high breath rates, common characteristics of neonatal patients. With functionality in any orientation, NomoLine provides a variety of sampling line options including nasal, nasal/oral, oxygen delivery, single nasal prong, and airway adapter sets. Soft, ergonomically curved cannulas help provide greater patient comfort.

NomoLine sampling lines are compatible with NomoLine ISA™ capnography modules, including ISA CO2, ISA AX+, and ISA OR+ for multigas monitoring. ISA modules are available on the expandable Masimo Root® Patient Monitoring and Connectivity Platform through Root's Masimo Open Connect™ (MOC-9™) ports, as well as on more than 70 OEM monitors, including those from Spacelabs, Schiller, Ortivus, Siare, and Edan. In addition, the Rad-97™ Pulse CO-Oximeter® is now available with an integrated module allowing direct connection to NomoLine sampling lines.

"With NomoLine, we've developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use," said Joe Kiani, Founder and CEO of Masimo.

Rad-97 and neonatal NomoLine and ISA products are currently available in the United States only.

NomoLine High Humidity Nasal Cannula, High Humidity Airway Adapter Set for Infant/Neonatal Patients, and Low Humidity Oral/Nasal Cannula with Oxygen Delivery

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of NomoLine™ capnography. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including NomoLine capnography, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Supports World Pneumonia Day Efforts

"Every Breath Counts Coalition" Aims to Help Governments End Preventable Pneumonia Deaths in a Set of African Countries by 2030

Irvine, California – November 13, 2017 – In conjunction with World Pneumonia Day on Sunday, November 12, Masimo (NASDAQ: MASI) announced its continuing efforts to help combat the global burden of pneumonia.

Each year, it is estimated that 178,000 newborns and 773,000 children die from pneumonia, making it the leading global cause of death in children under five.1 Increasingly, the major pneumonia burden is in the first 2 years of life, with the problem being particularly challenging in low-resource settings such as sub-Saharan Africa.2,3

It is time for action in eliminating pneumonia. Today Masimo and its partners in the fight against pneumonia are debuting a documentary entitled United for Oxygen, examining the problem, available at this link, and ask for your assistance in spreading the word across the world.

Along with more than 30 other organizations, including UNICEF, Save the Children, The Newborn Foundation, The Bill & Melinda Gates Foundation, The Clinton Health Access Initiative, GSK, and Philips, Masimo is a founding member of the "Every Breath Counts Coalition," dedicated to eliminating all pneumonia-related deaths. Each member of the coalition brings unique expertise to the problem, with some working on pneumococcal vaccine coverage, some on access to medical oxygen, others on education, and, in Masimo's case, the use of SET® pulse oximetry, the most accurate and reliable pulse oximetry in the world;4 pulse oximetry is often included in relevant pneumonia clinical screening protocols. As part of a grant from The Bill & Melinda Gates Foundation, Masimo has developed Rad-G™, a low-cost pulse oximeter that can be used as part of pneumonia screening, amongst other applications.

Joe Kiani, Founder and CEO of Masimo, said, "Eliminating pneumonia will take everyone's unified efforts. Together we can bend the curve and eliminate preventable childhood deaths from pneumonia, so no child has to fight to breathe. How can you help? Join the 'Every Breath Counts Coalition.'"

Rad-G is currently not available for sale in the United States, Canada, or the E.U.

@MasimoInnovates || #Masimo || #EveryBreathCounts || #United4Oxygen || #StopPneumonia || #NewbornFoundation || #GobeeGroup || #GatesFoundation

References
1. Miles, Carolyn. Partnering to Fight Pneumonia, The 'Forgotten Killer' of Children. Huffington Post. 31 October 2017. https://www.huffingtonpost.com/entry/59f8d6d6e4b0b7f0915f6271.
2. Walker CL, Rudan I, Liu L, et al. Global burden of childhood pneumonia and diarrhea. Lancet 2013; 381: 1405–16.
3. Green and Kolberg. Neonatal pneumonia in sub-Saharan Africa, Pneumonia (2016) 8:3 DOI 10.1186/s41479-016-0003-0.
4. Published clinical studies on Masimo SET® pulse oximetry can be found at http://www.masimo.com/home/clinical-evidence/masimo-set-pulse-oximetry/.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET® and Rad-G™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET® and Rad-G, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Distribution of Rad-57® Pulse CO-Oximeters® by The Jeffrey Lee Williams Foundation to First Responders

Foundation Awards Devices to York County EMS Departments to Assist in Monitoring for Presence of Carbon Monoxide

Rock Hill, York County, South Carolina – November 7, 2017 – Masimo (NASDAQ: MASI)announced today that The Jeffrey Lee Williams Foundation has distributed 20 Masimo Rad-57® Pulse CO-Oximeters® to EMS departments in York County, South Carolina, with the majority going to Piedmont Medical Center EMS. The Foundation purchases equipment that assists in monitoring for the presence of carbon monoxide (CO) and donates it to the community and local fire and first response agencies. The Rad-57s were awarded to the departments at an event on November 6.

The Jeffrey Lee Williams Foundation was founded in 2013 to honor the tragic loss of Jeannie Williams' son Jeffrey at the age of 11 to CO poisoning. Its mission is to help prevent CO poisoning by facilitating the distribution and placement of equipment to detect and monitor for CO. Currently, the Foundation is working in York County to sponsor the distribution of 2,000 CO alarms among all 18 fire districts in York County for installation in residential homes, the distribution of 45 "always-on" CO monitors among fire departments and EMS departments, and the distribution of the 20 Masimo Rad-57s to first responders and EMS departments.

CO poisoning is a leading cause of unintentional poisoning deaths in the United States.1 In addition, just one severe CO exposure event nearly doubles the risk of premature death, and consistent CO exposure may cause long-term heart and brain damage.2,3 Even mild levels of CO circulating in the blood rob the heart and brain of oxygen, which can cause mental confusion, leading to poor decision making and increasing the risk of heart disease or stroke – two conditions that account for nearly 50% of on-duty firefighter deaths.4,5

Rad-57 provides oxygen saturation, pulse rate, and perfusion index measurements using SET® Measure-through Motion and Low Perfusion™ pulse oximetry. In addition, it includes SpCO®, a noninvasive rainbow® parameter, to measure the amount of carboxyhemoglobin in red blood cells; carboxyhemoglobin forms after exposure to CO. Noninvasive SpCO monitoring may lead to the identification of elevated CO levels that might otherwise go undetected in front-line settings.

Amber Williams, Co-founder of The Jeffrey Lee Williams Foundation, South Carolina, "We are thrilled to offer Piedmont Medical Center EMS and two other rescue squads the Rad-57s! These devices will provide quick, noninvasive, objective data to responders to assist in the identification and treatment of CO exposure in our community."

Jeannie Williams, Co-founder, added, "Thank you Masimo for your support as we work to help others in Jeffrey's memory."

Joe Kiani, Founder and CEO of Masimo, said, "We are saddened by the loss of life due to CO poisoning and delighted to help support The Jeffrey Lee Williams Foundation's important work. We hope that Rad-57 and SpCO technology can help to identify elevated CO levels in York County EMS responders, firefighters, and civilians."

SpCO is intended to be used to monitor CO levels in the blood and is not intended to be used as the sole basis for making diagnosis or treatment decisions related to carbon monoxide poisoning. SpCO monitoring is not intended to replace laboratory blood testing; blood samples should be analyzed by laboratory instruments prior to clinical decision making.

@MasimoInnovates || #Masimo

References
1. Carbon Monoxide Exposures, United States, 2000-2009. Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6030a2.htm.
2. Hampson NB et al. Increased long-term mortality among survivors of acute carbon monoxide poisoning. Crit Care Med. 2009; 37(6):1941-47.
3.Bledsoe BE. The heart dangers of CO: Understanding cardiovascular risks to responders from CO exposure. J Emerg Med Svcs. 2007; 32:54-59.
4. Jakubowski G. The Invisible Incidents: How to respond to CO alarms. FireRescue Magazine. 2004; 22(11):52-55.
5. Bledsoe BE. The Perils of CO. FireRescue Magazine. September 2005.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
The Jeffrey Lee Williams Foundation
Jeannie and Amber Williams
info@jeffreysfoundation.org

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

San Diego Bankruptcy Court Rules Sotera Employees Misappropriated Masimo Trade Secrets

San Diego, California – October 16, 2017 – Masimo (NASDAQ: MASI) announced today that the bankruptcy court in San Diego has issued final judgment, holding that Sotera Wireless employees misappropriated Masimo trade secrets. The misappropriation stems from two former Masimo employees, James Welch and David Hunt, copying thousands of confidential Masimo documents, and using Masimo's trade secrets to benefit Sotera. The Court found clear and convincing evidence that willful and malicious misappropriation exists. The court also found that the actions of Welch and Hunt were "despicable conduct," and that they "consciously disregarded Masimo's rights."

The Court has permanently enjoined Sotera from retaining, disclosing, disseminating or using confidential Masimo documents, originating from either James Welch's or David Hunt's Masimo computers. The Court also enjoined Sotera, until September 16, 2021, from including Mr. Welch in Sotera's Design Control process, including preparing the Customer Needs Document, the Design Input Requirements documentation, the Software Requirements Specification or User Story, implementing software design and the Software Design Specification, the Design Review, the Verification process, the Validation process, developing schematics and other production specifications, and preparing the design history file. David Hunt had not been working at Sotera since 2015. Masimo understands that Mr. Welch is also no longer employed by Sotera.

This case was originally the subject of an action in the Superior Court of Orange County filed in May 2013 against Welch, Hunt and Sotera. This portion of that case was tried in the bankruptcy court in San Diego after Sotera filed for Chapter 11 bankruptcy in 2016. Thus, the San Diego ruling concerned the misappropriation of Masimo's trade secrets by Sotera. The remaining portion of the Superior Court action against Welch and Hunt remains pending.

Joe Kiani, Founder and CEO of Masimo, said, "I am sad that we even had to pursue this case. These were trusted employees. I hope all members of Masimo's team will adhere to Masimo's guiding principles of 'remaining faithful to your promises and responsibilities, being driven by fascination and accomplishment, not power and greed, making every day as fun as possible, making themselves better each year, and, doing what is best for patient care.' We believe these guiding principles are critical not only to our success, but to our integrity and humanity."

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Full Market Release of rainbow Acoustic Monitoring Sensor RAS-45

Irvine, California – September 28, 2017 – Masimo (NASDAQ: MASI) announced today the full market release of RAS-45, an adhesive adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM™). RAS-45 offers the same performance as the currently available RAS-125c sensor but in a smaller size, with more flexible adhesive.



Masimo rainbow Acoustic Monitoring® RAS-45 Acoustic Respiration Sensor

RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo's RAS-125c and now RAS-45, that is applied to the patient's neck area. Using acoustic signal processing that leverages Masimo Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous respiration rate (RRa®) and respiratory waveform, with the option to listen to the sound of breathing from the acoustic sensor.

RRa has been shown to be accurate1,2, easy-to-use1, easy-to-tolerate1,3, and reliable1, and has also been shown to enhance patient compliance with respiration monitoring. In a study comparing pediatric patient tolerance of sidestream capnography with a nasal cannula to respiration rate monitoring with an RAS-125c acoustic sensor, 15 out of 40 patients removed the cannula, while only one removed the acoustic sensor.3 In a study of 98 patients consciously sedated during upper gastrointestinal endoscopy, researchers found that RRa monitoring with the RAS-125c sensor more accurately assessed respiration rate than capnography using end-tidal carbon dioxide (EtCO2) measurement or impedance pneumography.2 RAS-45 maintains the same performance parameters, range, and accuracy specification as RAS-125c.



Masimo Root® Patient Monitoring and Connectivity Platform with rainbow Acoustic Monitoring® RAS-45 Acoustic Respiration Sensor

With its smaller size, RAS-45 is well suited for monitoring pediatric patients and patients with shorter necks. The RAS-45 adhesive is transparent, lighter, and more flexible than the RAS-125c adhesive. Like RAS-125c, RAS-45 operates with Masimo MX technology boards to measure RRa, display the acoustic respiration wave form, and optionally allow clinicians to listen to the sound of breathing. Both sensors are for adult and pediatric patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, "RAM harnesses the power of our breakthrough signal processing technology and applies it to a respiratory measurement derived from the sound of breathing. With the addition of the RAS-45 sensor, RRa is now a more convenient and comfortable measurement for clinicians and patients – especially children."

Continuous monitoring of respiration rate can be helpful in cases such as sedation-based procedures and post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation (respiration) monitoring for all patients receiving opioid-based pain medications.4,5

@MasimoInnovates || #Masimo

References
1. Macknet MR et al. Accuracy and Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric Patients. Anesthesiology. 2007;107:A84 (abstract).
2. Goudra BG et al. Comparison of Acoustic Respiration Rate, Impedance Pneumography and Capnometry Monitors for Respiration Rate Accuracy and Apnea Detection during GI Endoscopy Anesthesia. Open J Anesthesiol. 2013;3:74-79.
3. Patino M et al. Accuracy of Acoustic Respiration Rate Monitoring in Pediatric Patients. Paediatr Anaesth. 2013 Sep 3.
4. Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.
5. The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. www.jointcomission.org.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo RAS-45, RAM™, and RRa®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo RAS-45, RAM, and RRa, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA Clearance and Full Market Release of Rad-97™
Pulse CO-Oximeter®

Irvine, California – September 18, 2017 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance and full market release of Rad-97™ Pulse CO-Oximeter®, including configurations with integrated NomoLine™ capnography and noninvasive blood pressure (NIBP) measurement from SunTech Medical. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion™ SET® pulse oximetry and upgradeable rainbow® technologies, in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.

"We're excited to bring the easy-to-use, compact Rad-97 to the US," said Joe Kiani, Founder and CEO of Masimo. "Rad-97 brings together our core SET® and rainbow® technologies with advanced, workflow-enhancing connectivity solutions. We believe it will be an indispensable addition to many healthcare environments, including lower-acuity settings in hospitals, alternate care, and telehealth."



Masimo Rad-97™ Pulse CO-Oximeter® (center)
Rad-97 with Integrated Noninvasive Blood Pressure (left)
Rad-97 with Integrated NomoLine™ Capnography (right)

Rad-97 combines its portable, compact form factor with a high-resolution, multi-touch color display that allows clinicians to easily customize the device for each monitoring use case — bringing rainbow SET™ measurements to care areas where a small footprint or high portability is desired. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. A rechargeable battery lasting approximately four hours allows Rad-97 to be used in situations where extended operation without access to AC power is needed. An optional roll stand allows for tetherless device transport, offering additional flexibility in situations where space is limited.

Rad-97 features built-in enterprise WiFi capability, allowing it to connect wirelessly to supplemental patient monitoring systems including Masimo Patient SafetyNet™*, facilitating automatic data transfer to hospital electronic medical record (EMR) systems. The easy-to-use, intuitive interface helps to simplify charting workflows for vital sign monitoring and patient data capture. Rad-97 is also compatible with existing nurse call systems. Data from extended monitoring sessions, such as sleep studies, can be rapidly downloaded via USB, Ethernet, or WiFi.

Rad-97 also supports point-to-point Bluetooth® wireless connections with compatible devices, such as thermometers, glucometers, and weight scales, allowing patient data to be seamlessly transferred to Rad-97 and connected upstream systems. Rad-97 will also be available with an optional camera that will provide a high-resolution video feed, as well as audio, to the Patient SafetyNet view-station. The camera-equipped Rad-97 will allow patients and clinicians to communicate remotely with compatible Patient SafetyNet software, making it well-suited as a point-of-care device for telehealth.

Rad-97 with capnography features an integrated ISA™ CO2 module with NomoLine sampling lines for sidestream capnography, with an adapter for intubated patients — meeting continuous monitoring and capnography needs in a single device. Rad-97 with capnography displays continuous end-tidal carbon dioxide (EtCO2) monitoring with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate. NomoLine capnography reduces delays in respiration rate measurement in both low and high ranges, accurately measures respiration rate, and reduces the incidence of filter line occlusions, as a result of NomoLine moisture wicking technology.

With Rad-97 NIBP, oscillometric blood pressure is available in three NIBP measurement modes: spot-check, automatic interval (which measures blood pressure routinely, at a desired interval), and stat interval (which continually measures blood pressure for a desired duration). An integrated port allows clinicians to connect a blood pressure cuff inflation hose directly to Rad-97; the port is compatible with both disposable and reusable cuffs, for adult, pediatric, and neonatal patients.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Newborn Foundation and Masimo Partnership Reaches 52,000 Babies and 1,000 Health Workers through Newborn Screening Initiative in Support of Every Woman Every Child

BORN Project convenes public health stakeholders to highlight key program successes at three-year mark, reinforcing global call to action to support universal newborn pulse oximetry screening as a tool to significantly reduce newborn mortality and drive treatment infrastructure in low-resource settings

Sichuan Province, China – September 14, 2017 – Masimo (NASDAQ: MASI) and the Newborn Foundation today announced that the BORN Project, their joint commitment to the United Nations' Every Woman Every Child (EWEC) initiative, has now screened 52,000 newborns across 40 delivery sites in China for critical congenital heart disease (CCHD), pneumonia, and sepsis. In addition, 1,000 health workers and public health staff have now been trained in neonatal pulse oximetry screening through the BORN project, which is also marking its third anniversary.

These progress updates will be discussed at a UN General Assembly event in New York City on Tuesday, September 19, "Harnessing the Power of Technology and Partnerships to Combat Newborn Mortality." The announcement comes on the heels of news that the National Health and Family Planning Commission, People's Republic of China, and the Chinese CDC have convened a formal national committee to establish country-wide implementation and screening protocols for universal newborn pulse oximetry screening.

The BORN (Birth Oximetry Routine for Newborns) Project, developed by the Newborn Foundation in partnership with Masimo, aligns with public health initiatives with the goal of reducing newborn mortality from CCHD, pneumonia, and sepsis in pilot regions. It also provides substantive data to public health officials to demonstrate the importance of investment in sustainable universal newborn screening programs and improved access to follow-up care for fragile babies.

The project has provided the first large deployment of smart device-paired pulse oximeters for use on newborns. Training and educational tools, combined with the Masimo iSpO2® Rx smartphone- and tablet-paired pulse oximeter, teach families about the benefits of screening and allow healthcare workers at every level to screen babies and interpret screening results, helping to increase the rate of timely diagnosis and referrals.

"We have more than met the goals of the project since its launch, and seeing the impact on so many lives has been humbling," said Annamarie Saarinen, CEO of the Newborn Foundation. "The real impact has been in working in partnership with the government to bring this policy to fruition."

The BORN Project is conducted in collaboration with the China Office for Maternal and Child Health Surveillance, the China CDC, the Mianyang Health Bureau. It has been supported by Masimo, the Masimo Foundation, and the London-based Global Innovation Fund. An interim report on the findings of its impact of screening at hospitals in rural Sichuan Province was recently presented to the National Health and Family Planning Commission of the People's Republic of China and Chinese CDC.

Established through an initial three-year, $50,000 commitment from Masimo in 2014 and subsequent $100,000 equipment donation, the BORN Project has now launched in the Philippines, where it is in the process of screening 72,000 newborns across 28 urban and rural hospitals, spanning all three island groups. The BORN Project is also expanding into India, Peru, Mexico, Bolivia, Pakistan, and Mongolia. The Newborn Foundation leads advocacy and implementation efforts, which focus on education, training and metrics on the benefits of routine pulse oximetry screening of newborns, as well as follow up diagnosis and treatment protocols.

"We must reframe how healthcare is delivered to the youngest and most fragile patients," said Joe Kiani, Founder and CEO of Masimo. "The work we are doing is already having a powerful impact in China and beyond. We are proud that Masimo SET®, with its proven clinical accuracy and reliability, is able to help save the lives of many newborns."

Every Woman Every Child

The Masimo and Newborn Foundation partnership was among the first commitment makers as part of the UN Secretary General's Every Woman Every Child initiative. EWEC directly contributes to the Global Strategy for Women's, Children's and Adolescents' Health and the success of the Sustainable Development Goals (SDGs).

With more than 50,000 rural and underserved babies impacted through their work thus far, Masimo and the Newborn Foundation, in collaboration with EWEC, are committed to addressing obstacles and tackling the unmet Millennium Development Goals for reducing mortality for children under the age of five, through the SDG initiatives.

iSpO2 Rx does not have 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Newborn Foundation
The Newborn Foundation conducts research, implements programs, and develops technology innovations that save lives and improve health outcomes for the newest, most vulnerable citizens of the world. The Foundation programmatically delivers these solutions to those who need them most and drives policies that integrate with public health initiatives to provide sustainable impact for babies and families.

About Every Woman Every Child
Launched in 2010 and led by the UN Secretary-General, the Every Woman Every Child movement aims to intensify national and international commitment and action by governments, the UN, multilaterals, private sector and civil society to keep women's, children's and adolescents' health and wellbeing at the heart of development. As a multi-stakeholder platform to operationalize the Every Woman Every Child Global Strategy for Women's, Children's and Adolescents' Health, the movement mobilizes partnerships and coordinated efforts across sectors to ensure that all women, children and adolescents not only survive, but also thrive to help transform the world. Since 2015, 62 country and around 150 multi-stakeholder commitments have been pledged in support of the EWEC Global Strategy, totaling nearly US$30 billion to deliver on the promises of a sustainable future for all. More information is available at http://www.everywomaneverychild.org.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo iSpO2® Rx. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo iSpO2 Rx, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Annamarie Saarinen
Newborn Foundation
Email: annamarie@newbornfoundation.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Evaluates Performance of Masimo iSpO2® Rx Smart Device-Paired Pulse Oximeter in Screening Newborns for Critical Congenital Heart Disease

Neuchatel, Switzerland – September 5, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers in Maastricht, Netherlands evaluated the performance of Masimo iSpO2® Rx in screening newborns for critical congenital heart disease (CCHD).1 iSpO2 Rx is a smart device-paired pulse oximeter featuring Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology.

CCHD affects approximately 2.5 to 3 newborns per 1000 live births2 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.3 In the study, Dr. Huizing and colleagues sought to evaluate the accuracy of iSpO2 Rx because of increasing trends toward out-of-hospital births and concerns about the costs of CCHD screening implementation in low-resource settings. The researchers surmised that a portable, low-cost pulse oximeter may be more practical in such settings than standalone hospital devices.

The researchers enrolled 201 infants in the study. CCHD screening was conducted 12-24 hours after birth by two independent teams, who were blinded to the other team's results. Each team took both preductal (right-hand) and postductal (either foot) oxygen saturation (SpO2) measurements to establish whether an infant passed, failed, or needed a repeat screening. One team measured SpO2 using a Masimo Radical-7® Pulse CO-Oximeter® equipped with disposable Masimo LNCS® sensors. The other team used a Masimo iSpO2 Rx equipped with a reusable M-LNCS™ YI sensor, connected to an Apple iPad Mini.

Applying Bland-Altman analysis to the preductal SpO2 values of the 201 screened infants, with Radical-7 as the reference device, the researchers calculated a mean bias of -0.08% ± standard deviation of 1.76%, with limits of agreement of -3.52% and 3.36%. For postductal SpO2 values, they calculated a mean bias of -0.11% ± standard deviation of 1.68%, with limits of agreement of -3.41% and 3.18%.

In addition, to evaluate the ability of iSpO2 Rx to measure low oxygen saturation, the researchers also enrolled a group of 12 infants admitted to the neonatal intensive care unit (NICU) with SpO2 lower than 95%. SpO2 was continuously monitored for 10 minutes, with readings recorded once per minute, and with one foot connected to the iSpO2 Rx and the other to a Philips IntelliVue MP70 monitor equipped with Masimo SET® technology. Using the Philips monitor as the reference device, the researchers calculated a mean bias of 0.01% ± standard deviation of 1.74%, with limits of agreement of -3.42% and 3.43%.

The researchers concluded that, "Our data suggest that CCHD screening with the Masimo iSpO2 Rx is feasible and accurate. The use of reliable smartphone-paired pulse oximeters may contribute to the extension of CCHD screening to home births and low resource settings." They also noted that, "The iSpO2 Rx demonstrated a high degree of agreement with the Masimo Radical-7, a hospital-grade pulse oximeter."

The device used in this study is iSpO2 Rx. The study did not use the iSpO2, which is intended as an exercise and wellness product and is not available for use on neonates. iSpO2 is not intended for CCHD screening or any other medical use.

iSpO2 Rx does not have 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Huizing M, Villamor-Martinez-E, Chavagne I, Vanagt W, Spaanderman M, and Villamor E. Reliability and Validity of a Smartphone-Paired Pulse Oximeter for Screening of Critical Congenital Heart Defects in Newborns. Neonatology. 2017;112:324–329. DOI: 10.1159/000477294.
2. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-1900.
3. 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygience, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Hearth Disease in Newborns. Page 7.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Evaluates Utility of Masimo SpHb® During High-Blood-Loss Oncosurgery

Neuchatel, Switzerland – August 28, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers in New Delhi, India evaluated the utility of Masimo SpHb®, noninvasive, continuous hemoglobin measurement, during oncosurgery on patients with high anticipated blood loss.1

In the study, Dr. Gupta and colleagues sought to evaluate the utility of SpHb measurements on patients undergoing oncosurgery because oncosurgeries "may be associated with large blood loss, requiring repeated haemoglobin estimation for deciding the need for intraoperative blood transfusion." They enrolled 50 adult patients with anticipated blood loss of at least 20%. During surgery, the patients' SpHb was continuously monitored using a Masimo Radical-7® Pulse CO-Oximeter®. The researchers obtained venous blood samples, which were analyzed using a Beckman Coulter analyzer (LabHb), at the following points: immediately after induction, when approximately 500 ml of blood loss was suspected, and just before reversal of the neuromuscular blockade.

A total of 137 paired (SpHb and LabHb) data points were recorded for final analysis, including 66 at which packed red blood cell transfusions were made. The accuracy of SpHb in comparison to LabHb was assessed using Bland-Altman analysis. The level of agreement between SpHb and LabHb for the 66 transfusion data points showed a 73% correlation (p < 0.001), bias of -0.313 g/dL with standard deviation of ± 1.06 g/dL, and limits of agreement of -2.44 g/dL and 1.81 g/dL. The level of agreement between SpHb and LabHb for all 137 data points showed a 72.7% correlation (p < 0.001), bias of -0.376 g/dL with standard deviation of ± 1.27 g/dL, and limits of agreement of -2.92 g/dL and 2.16 g/dL.

The researchers concluded that, "Continuous SpHb monitoring can aid us regarding early blood transfusion decisions in oncosurgical patients along with other measures such as clinical judgement by attending consultant and haemodynamic variables. It may improve the intraoperative management of oncosurgeries by helping in real time and continuous decision-making for blood transfusion." They also noted that SpHb "allows the physician to focus on the haemoglobin trend and detect either a slow decrease or a significant rapid drop in haemoglobin and therefore decide the appropriate time to perform an invasive measurement of haemoglobin."

As limitations, the researchers stated that they "collected venous blood sample from central venous line rather [than] arterial blood. Haemoglobin concentration has been reported to be higher in venous blood than arterial blood though precision for haemoglobin estimation is higher for venous blood." In addition, they suggested that further research may be needed to assess the effect of colloid administration and skin temperature at the probe site on SpHb accuracy, as well as its accuracy on patients with blood loss rates differing from the "massive but steady" rates observed in this study.

SpHb monitoring is not intended to replace laboratory blood testing. Blood samples should be analyzed by laboratory instruments prior to clinical decision making.

@MasimoInnovates || #Masimo



References
1. Gupta N, Kulkami A, Bhargava AK, Prakash A, and Gupta N. Utility of noninvasive haemoglobin monitoring in oncosurgery patients. Indian Jour Anesth. July 2017; Volume 61; Issue 7; 543-548.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery

Neuchatel, Switzerland – August 21, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Firat University in Turkey evaluated the performance of Masimo PVi®, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during respiratory cycles, as the basis of a goal-directed fluid therapy (GDFT) protocol during laparoscopic bariatric surgery on mechanically-ventilated patients.1

In the study, Dr. Demirel and colleagues sought to evaluate whether using GDFT guided by PVi on morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery might result in less intravenous fluid use without compromising outcomes. They enrolled 60 patients and divided them randomly into control and GDFT groups. The control group's fluid levels were managed by standard fluid therapy, using mean arterial pressure (MAP) and central venous pressure (CVP) measured via a central venous access catheter as indicators of fluid responsiveness. The GDFT group's fluid status was monitored using a GDFT protocol based on PVi as a noninvasive, dynamic indicator of fluid responsiveness.

Both groups were initially administered 500 mL bolus colloid fluid at the beginning of surgery, followed by a continuous infusion of crystalloid fluid (4-8 mL/kg/h in the control group, or 2 mL/kg/h in the GDFT group per the protocol). In the control group, if CVP was less than 6 mmHg or MAP less than 65 mmHg, a 250 mL additional bolus of colloid fluid was administered. In the GDFT group, if PVi was greater than 14% for five minutes, the 250 mL colloid bolus was administered.

The researchers found that there was a significantly higher mean volume of crystalloid fluid administered in the control group (1499 mL ± 516.87 mL) compared to the GDFT group (1126 mL ± 234.98 mL) (p = 0.001). There were no significant differences in blood lactate levels (p greater than 0.05) or creatinine levels before and after surgery (p greater than 0.05) between the two groups.

The researchers concluded that, "Utilization of GDFT protocols based on PVi may prevent excessive intraoperative infusion of fluids in laparoscopic bariatric surgery. This method when intending to prevent intraoperative excessive fluid loading in RYGB surgery appears to have no effect on either renal functions or lactate levels. While this study shows the adequacy of PVi for fluid therapy in mechanically ventilated patients undergoing bariatric surgery, further research is warranted to assess adequacy of optimization of PVi."

@MasimoInnovates || #Masimo

Reference
1. Demirel I, Bolat E, Altun AY, zdemir M, and Beta A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 31 July 2017. DOI: 10.1007/s11695-017-2840-1.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Dubai Health Authority Implements Masimo Patient SafetyNet™

Dubai, United Arab Emirates – August 14, 2017 – Masimo (NASDAQ: MASI) announced today that the Dubai Health Authority (DHA), the government organization that oversees the healthcare systems of Dubai, is augmenting its current inventory of Masimo equipment and technology with the implementation of Masimo Patient SafetyNet™*, a supplemental remote monitoring and clinician notification system, at two hospitals in Dubai.

Masimo Patient SafetyNet enables information from bedside monitors, such as Masimo Root® with the Radical-7® or wearable Radius-7® Pulse CO-Oximeter®, to be accessible from a central viewing station. When changes occur in measured values, which may indicate deterioration in a patient's condition, Patient SafetyNet automatically sends wireless alerts directly to clinicians, wherever they may be. In addition, Patient SafetyNet can automate the transfer of patient data, including admission data, vital signs, early warning scores (EWS), and other physiological parameters, directly to hospital electronic medical record (EMR) systems, helping to improve clinician workflows and reduce the possibility of transcription errors.

Dr. Andreas Taenzer and colleagues found in an 11-month study conducted at Dartmouth-Hitchcock Medical Center that using Patient SafetyNet and Masimo SET® pulse oximetry as part of a comprehensive alarm management strategy reduced rescue events by 65% and intensive care unit transfers by 48%, and as a result, reduced costs by $1,480,000.1,2 In a subsequent article, they announced that after five years, Dartmouth-Hitchcock had had zero preventable deaths or instances of brain damage due to opioids since the installation of Patient SafetyNet.2 In 2016, after ten years, they reported achieving a 50% reduction in unplanned ICU transfers and a 60% reduction in rescue events, despite increases in patient acuity and occupancy.3

The two Dubai Health Authority medical centers implementing Patient SafetyNet are Dubai Hospital (625 beds), which provides general medical and surgical care, and Latifa Hospital (367 beds), which specializes in maternal and child care. Dubai Hospital installed its first Patient SafetyNet in 2013. Latifa Hospital is in the process of installing four systems, with a further system planned for Dubai Hospital. "We are excited to deepen our partnership with Masimo," said Humaid Al Qatami, Chairman of the Board and Director General of Dubai Health Authority. "The Dubai Health Authority's mission is to develop an integrated and sustainable healthcare system that ensures our comprehensive services achieve the highest international standards, and we believe that Masimo's monitoring devices, now even more connected to hospital infrastructure through the power of Patient SafetyNet, will help us meet that goal."

"Patient SafetyNet, in conjunction with Masimo SET® pulse oximetry, enables continuous supplemental monitoring of active patients in post-surgical wards and can help save the lives of patients on opioids, among many other benefits," said Joe Kiani, Founder and CEO of Masimo. "We applaud the Dubai Health Authority, dedicated to providing no less than the best health care in the world, for recognizing the importance of implementing such a proven and powerful centralized monitoring and patient surveillance system."

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study. Anesthesiology. 2010 Feb;112(2):282-7.
2. Taenzer AH et al. Postoperative Monitoring - The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.
3. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Evaluates Performance of Masimo SpHb® in Trauma Patients
with Low Hemoglobin Levels

Neuchatel, Switzerland – August 7, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Cairo University in Egypt evaluated the performance of Masimo SpHb®, noninvasive, continuous hemoglobin measurement, in trauma patients with low hemoglobin levels.1

In the prospective, observational study, Dr. Gamal and colleagues sought to evaluate SpHb measurements on trauma patients with low hemoglobin levels (below 8 g/dL) because trauma patients are "vulnerable to frequent blood transfusion." They enrolled 70 adult patients with hemoglobin levels lower than 8 g/dL who were admitted to the emergency department (ED) of Cairo University Hospital and scheduled for surgical intervention. While in the ED, the patients' SpHb was continuously monitored using a Masimo Radical-7® Pulse CO-Oximeter®, with initial baseline measurement recorded as well as measurement after each unit of blood was administered. The researchers simultaneously obtained 2 mL venous blood samples, which were analyzed using a Coulter LH 750 Beckman analyzer (LabHb).

A total of 184 samples with corresponding SpHb values were collected for final analysis. The distribution of LabHb values was 20 (11%) below 6 g/dL, 97 (53%) between 6-7 g/dL, and 67 (36%) between 7-8 g/dL. The accuracy of SpHb in comparison to LabHb was assessed using Bland-Altman analysis. The level of agreement between SpHb and LabHb showed a bias of 0.12 g/dL and limits of agreement of -0.56 g/dL and 0.79 g/dL.

To determine the accuracy of SpHb as a trend measurement, the researchers also observed the change in hemoglobin (DeltaHb) before and after each unit of blood was transfused, for both methods. The level of agreement between DeltaSpHb and DeltaLabHb showed a bias of -0.05 g/dL and limits of agreement of -0.62 g/dL and 0.51 g/dL.

The researchers concluded that "SpHb showed accurate precision in both absolute values and trend values compared to LabHb measurement in trauma patients with low hemoglobin levels." They also suggested several possible uses for SpHb, including as "a trend monitor that would alert the physician to any sudden bleeding mishaps," and as a "good supplementary measure" to LabHb that can "save time and effort."

The researchers acknowledged that this study is not sufficient to alone answer the question, "Can we transfuse blood relying solely on SpHb or not?" However, they noted that their findings add to the body of evidence in favor of SpHb and suggest the need for additional research regarding the role of Masimo technology in blood transfusion decisions.

SpHb monitoring is not intended to replace laboratory blood testing. Blood samples should be analyzed by laboratory instruments prior to clinical decision making.

@MasimoInnovates || #Masimo

The accuracy specification of SpHb is 1 g/dL ARMS* in the range of 8-17 g/dL. SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation against an invasive laboratory device. SpHb accuracy has not been validated in conditions of motion or low perfusion.

*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study.

Reference
1. Gamal M, Abdelhamid B, Zakaria D, Abd El Dayem O, Ashraf R, Fawzy M, and Hasanin A. Evaluation of noninvasive hemoglobin monitoring in trauma patients with low hemoglobin levels. Shock. July 2017. DOI: 10.1097/SHK. 0000000000000949.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Compares Performance of Masimo Acoustic Respiration Rate (RRa®) and Nellcor Plethysmographic Respiration Rate in Volunteers

Tokyo, Japan – July 31, 2017 – Masimo (NASDAQ: MASI) announced today that researchers at the Tokyo Women's Medical University, Department of Anesthesiology, in Japan have published a study investigating the measurement of respiration rate in volunteers. Masimo acoustic respiration rate (Masimo), using the Masimo Radical-7® Pulse CO-Oximeter®, was studied alongside Nellcor plethysmographic respiration rate (Nellcor), using the Nellcor PM1000N.1

Dr. Kitsiripant and colleagues enrolled 50 healthy adult volunteers in the study. Respiration rate, pulse rate, and oxygen saturation (SpO2) values were measured using the two technologies: Nellcor respiration rate, pulse rate, and SpO2 on PM1000N (version 2.0.20.0) were measured using an SpO2 adhesive sensor on the left index finger; Masimo respiration rate on Radical-7 (V.7910, processor V1.3.06i) was measured using the RAS-125c (rev D) acoustic sensor on the left side of the neck, with an R1-25L adhesive sensor on the right index finger measuring Masimo pulse rate and SpO2.



Masimo Radical-7® Pulse CO-Oximeter® with RAS-125c Respiratory Acoustic Sensor

Both devices were configured to alarm in the event of respiratory pause (Masimo) or low respiration rate (Nellcor) for 30 seconds, respiration rate under 10 breaths/minute, and SpO2 of 90% or below. The volunteers were required to breathe at a rate of 12 breaths/minute for 3 minutes, then hold their breath until one of the device's respiratory pause/low respiration rate alarms was triggered, then resume breathing. Because of the difficulty for some volunteers of completely stopping airflow for 30 seconds, a smaller group of 10 volunteers was recruited to perform the same procedure but with respiratory pause/low respiration rate alarms set to 15 seconds.

Of the 143 procedures in which breathing was successfully held for more than 30 seconds, Masimo alarmed 114 times and Nellcor alarmed 15 times. The average time to alarm for Masimo was 35 seconds and for Nellcor, 59 seconds. Most of the alarms for Nellcor followed from SpO2 being less than 90%, whereas most for Masimo were caused by respiration rate greater than 10 breaths/minute (which tended to occur prior to the drop in SpO2). Of the 29 procedures in which breathing was held for 15 seconds, Masimo alarmed 29 times, with an average time to alarm of 21 seconds, and Nellcor did not alarm at all.

The researchers concluded that Masimo acoustic respiration rate provided faster detection of respiratory pause than Nellcor, but it should be noted as a limitation of the study that the measurements were taken using volunteer participants who maintained a fixed breathing rate and then abruptly held their breath.

rainbow Acoustic Monitoring® sensors and cables are indicated for the continuous, noninvasive monitoring of respiratory rate (RRa®). The RAS-125c sensor is indicated for adult and pediatric patients, in hospitals, hospital-type facilities, mobile and home environments.

@MasimoInnovates || #Masimo

Reference
1. Kitsiripant C et al. Comparison of Nellcor™ PM1000N and Masimo Radical-7® for detecting apnea in volunteers. J Anesth. 9 July 2017. DOI: 10.1007/s00540-017-2385-4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi® and RPVi™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi and RPVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Noninvasive RPVi™, a rainbow® Multi-Wavelength Index of Pleth Variability

Neuchatel, Switzerland – July 20, 2017 – Masimo (NASDAQ: MASI) announced today the CE marking of RPVi™, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during one or more respiratory cycles. RPVi is designed to show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.



Masimo Radical-7® Pulse CO-Oximeter® with RPVi™

RPVi, powered by Masimo rainbow® technology, is a multi-wavelength version of the currently available Pleth Variability Index (PVi®). RPVi is designed to provide enhanced specificity to changes in fluid volume compared to PVi.1

Several peer-reviewed clinical studies have evaluated the utility of the currently available measurement PVi as an indicator of fluid responsiveness in mechanically-ventilated patients. For example:

  • In a study of 82 patients undergoing major abdominal surgery, researchers found that PVi-based goal-directed fluid management reduced the volume of intraoperative fluid infused and reduced intraoperative and postoperative lactate levels.2
  • In a study of 109 patients undergoing colorectal surgery, researchers found that the implementation of an enhanced recovery protocol which included PVi led to improved patient satisfaction and substantial reduction in lengths of stay, complication rates, and costs for patients undergoing both open and laparoscopic colorectal surgery.3

Joe Kiani, Founder and CEO of Masimo, said, "Masimo rainbow® technology, first announced in 2005, continues to drive innovative new measurements and improvements to existing ones. We are proud to introduce RPVi, and hope that it will be useful to clinicians around the world in helping to improve patient care."

RPVi is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Masimo data on file.
2. Forget P et al. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010; 111(4):910-4.
3. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs After Colorectal Surgery. Journal of the American College of Surgeons. 2015. Doi: 10.1016/j.jamcollsurg.2014.12.042.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi® and RPVi™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi and RPVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of rainbow® Super Sensor

Masimo Super Sensor is the First Ever to Measure Arterial Oxygen Saturation (SpO2), Hemoglobin (SpHb®), Carboxyhemoglobin (SpCO®), Methemoglobin (SpMet®), Pleth Variability Index (PVi®), Index of Perfusion (Pi), and Pulse Rate (PR), All Noninvasively

Neuchatel, Switzerland – July 10, 2017 – Masimo (NASDAQ: MASI) announced today the CE marking of the rainbow® Super DCI®-mini sensor, a reusable spot-check sensor that features Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry and rainbow SET™ technology with multiple physiologic measurements – including, for the first time, the ability to measure total hemoblogin (SpHb®), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and arterial oxygen saturation (SpO2) using the same noninvasive reusable sensor.

In 2016, Masimo introduced the rainbow® DCI-mini sensor, enabling spot-check measurement of Next Generation SpHb and other parameters. Now, with the rainbow® Super DCI-mini sensor, an expanded set of parameters can be measured using a single sensor: SpO2, pulse rate (PR), perfusion index (Pi), pleth variability index (PVi®), SpHb, SpCO, and SpMet.



Masimo Rad-67™ Pulse CO-Oximeter® with rainbow® Super DCI®-mini Sensor

The rainbow® Super DCI-mini sensor can be used to spot-check all patients weighing 3 kg or more, further reducing the need for multiple sensor types; the sensor can be applied to an adult finger, a pediatric finger, or an infant finger, thumb, or great toe. The sensor is small and lightweight, with a flexible cable to provide sensor stability and patient comfort during monitoring.

Next Generation SpHb technology offers motion tolerance and a faster time to display SpHb results (in as few as 30 seconds). In addition, field performance has been enhanced in lower hemoglobin ranges. Next Generation SpHb is enabled when the Rad-67™ Pulse CO-Oximeter® and the DCI-mini or Super DCI-mini sensor are used together.

SpCO monitoring may lead to the identification of elevated carbon monoxide levels that might otherwise go undetected in front-line settings, such as triage and emergency care. SpMet helps clinicians monitor for methemoglobin in care areas where the drugs that cause methemoglobinemia are most common, such as procedure labs and the operating room.

Joe Kiani, Founder and CEO of Masimo, said, "This is an exciting day for us and hopefully a great opportunity to improve patient care. Since the invention of rainbow® technology, we have been wanting our customers to be able to measure SpCO, SpMet, SpHb and SpO2 simultaneously. Now they can! In addition, we have been pursuing a spot-check sensor that fits all patients across the age spectrum. We believe the rainbow® Super DCI-mini sensor will be especially valuable for use in triage and emergency care situations. We plan to introduce a continuous measurement version of the Super Sensor in the near future."

The rainbow® Super DCI-mini sensor, Next Generation SpHb, and Rad-67 have not received FDA 510(k) clearance and are not available for sale in the United States.

@MasimoInnovates || #Masimo

SpCO is intended to be used to monitor CO levels in the blood and is not intended to be used as the sole basis for making diagnosis or treatment decisions related to carbon monoxide poisoning. SpMet is not to be used as the sole basis for making diagnosis or treatment decisions related to methemoglobinemia. SpHb, SpCO, and SpMet monitoring are not intended to replace laboratory blood testing; blood samples should be analyzed by laboratory instruments prior to clinical decision making.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo rainbow® Super DCI®-mini sensor. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo rainbow® Super DCI-mini sensor, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

 

New Study Compares Performance of Masimo Next Generation SedLine® Patient State Index (PSi) to Original PSi During Anesthesia

Geneva, Switzerland – June 19, 2017 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at Euroanaesthesia 2017 in Geneva, Switzerland. In the study, researchers at University Medical Center Groningen, Netherlands compared original and Next Generation versions of Masimo Patient State Index (PSi, a processed EEG parameter related to the effect of anesthetic agents) during Masimo SedLine® brain function monitoring of patients under propofol and sevoflurane anesthesia.1



Masimo RD SedLine® Adult EEG Sensor

SedLine brain function monitoring features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, four EEG waveforms, a Density Spectral Array (DSA; an easy-to-interpret, high-resolution display of bi-hemispheric activity and EEG power), and PSi. Next Generation SedLine enhances PSi to make it less susceptible to electromyographic (EMG) interference and to improve its performance in low-power EEG cases.

In the study, Dr. Kuizenga and colleagues sought to compare the original and Next Generation PSi algorithms, referred to as PSi-1 and PSi-2, respectively, as they correlated with propofol and sevoflurane drug concentrations and with the Modified Observers Assessment of Alertness and Sedation (MOAAS) scale. They also sought to assess the influence of 2 and 4 ng/mL effect-site concentrations of remifentanil on the performance of the two algorithms.

The researchers enrolled 36 healthy volunteers, stratified by age, and assigned them randomly to a sequence of four sessions of anesthesia. In one session, propofol was administered in a series of graded steps; in the second, sevoflurane was similarly administered; in the third and fourth, the two concentrations of remifentanil were also administered. During each step of each session, after a twelve-minute delay for equilibration, MOAAS was tested and a blood sample was taken to measure drug concentrations. EEG was collected using Masimo Root® with SedLine, from which time-synchronized PSi-1 and PSi-2 values were later extracted. The researchers then plotted MOAAS, drug concentration, PSi-1, and PSi-2 values over time.

The researchers found that when charted against drug concentrations, PSi-2 showed "reduced population variability and improved baseline stability" compared to PSi-1. When charted against MOAAS, PSi-2 had "lower interindividual variability" than PSi-1. They also noted that "Both PSis distinguish MOAAS 5, 4, and 3 better during propofol anesthesia compared to sevoflurane. This difference disappears when adding remifentanil."

The investigators concluded that "PSi-2 [Next Generation SedLine PSi] has enhanced signal stability and a better description of the dose-response relationship. PSi-2 has therefore improved capacity as a pharmacodynamic monitor of anesthesia compared to PSi-1."

Next Generation SedLine has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

Reference
1. Kuizenga M.H., Colin P.J., Vereecke H.E.M., Struys M.M.R.F. Comparison between two versions of the Patient State Index during propofol and sevoflurane anesthesia, with or without remifentanil. Proceedings from Euroanaesthesia 2017, Geneva, Switzerland. Abstract #01AP07-4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Limited Market Release of Rad-67™ rainbow® Pulse CO-Oximeter® with Next Generation SpHb®



Masimo Rad-67™ Handheld Pulse CO-Oximeter® with rainbow® DCI®-mini Sensor

Neuchatel, Switzerland – June 5, 2017 – Masimo (NASDAQ: MASI) announced today, in conjunction with its CE marking, the limited market release of the Spot-Check Rad-67™ Handheld Pulse CO-Oximeter®. Rad-67 offers Measure-through Motion and Low Perfusion™ SET® pulse oximetry and upgradeable rainbow® noninvasive monitoring technology in a compact, portable spot-check device. With the universal reusable rainbow® DCI®-mini sensor, Rad-67 features Next Generation SpHb® (noninvasive total hemoglobin) technology.

Next Generation SpHb technology offers improved motion tolerance and a faster time to display SpHb results (in as few as 30 seconds). In addition, field performance has been enhanced in lower hemoglobin ranges. The rainbow® DCI-mini sensor allows patients of all ages, from infants to adults, to be spot-checked using a reusable sensor. Next Generation SpHb, enabled when Rad-67 and the DCI-mini sensor are used together, significantly advances the forefront of noninvasive portable hemoglobin spot-checking.

Rad-67's ability to provide portable spot-check measurements of both oxygen saturation and SpHb, in addition to other noninvasive rainbow® measurements, makes it a useful single-device solution in multiple care areas and mobile environments, such as when screening patients during blood donation drives, emergency room screening, and in physicians' offices. In addition to a rechargeable battery with six-hour run time, Rad-67 features a high-resolution, HD color display with intuitive touchscreen navigation that automatically adjusts brightness to optimize visibility in a variety of settings, including outdoors. The slim-profile sensor connector port is designed to provide tactile feedback upon proper connection. Multiple parameters are simultaneously displayed, allowing for quick patient assessment.

Rad-67 provides convenient historical data review directly on the device, with unique patient identifiers to help improve organization of records and workflow. Using Bluetooth®, Rad-67 can connect wirelessly to portable printers. Rad-67 also includes built-in wireless connectivity via Wi-Fi. When used in conjunction with Masimo Iris Gateway™ or Patient SafetyNet™*, data from Rad-67 can be sent directly to the patient's electronic medical record (EMR). Automating data transfer with EMR integration may help reduce the possibility of human error when manually transferring data.

Dr. Aryeh Shander, Chief of Anesthesiology, Critical Care Medicine at Englewood Hospital and Medical Center, noted that, "in the process of screening for anemia, having the ability to detect hemoglobin noninvasively is one of the greatest advances. Once low hemoglobin is reported, confirmation with a conventional laboratory test will further explore the possible causes."

Joe Kiani, Founder and CEO of Masimo, said, "We're proud to announce Rad-67 with Next Generation SpHb technology. Next Generation SpHb represents a significant enhancement to the noninvasive measurement we invented a decade ago – a measurement we look forward to continuing to improve."

Rad-67 has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-67™ Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-67 Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo and Mdoloris Announce Masimo Open Connect™ (MOC) Partnership for the Root® Patient Monitoring and Connectivity Hub

Analgesia Nociception Index (ANI®) Module for Root to be Previewed at the European Society of Anaesthesiology in Geneva, Switzerland June 3 – 5, 2017

Irvine, California and Lille, France – June 1, 2017 – Masimo (NASDAQ: MASI) and Mdoloris Medical Systems announced today a Masimo Open Connect™ (MOC) partnership for the Root® Open Architecture Patient Monitoring and Connectivity Hub, in which Mdoloris is developing and will commercialize their Analgesia Nociception Index (ANI®) technology for Root.

Masimo's unique approach to medical technology integration through MOC partnerships is expected to address some major barriers to new technology adoption in patient monitoring. Root's open architecture and built-in connectivity enable third-party companies to determine themselves whether to pursue an integrated product. They can then independently develop, obtain regulatory approvals, and commercialize their own external MOC-9 module or Masimo Open Connect Control (MOC-C™) App for Root using Masimo's MOC software development kit (SDK). Masimo's engineering team supports MOC partner development as needed and Masimo's commercial team helps increase awareness of the availability of MOC-9 modules and MOC-C Apps from MOC partners. In turn, MOC partners use their existing distribution channels to sell their MOC-9 module or MOC-C App to Masimo customers already using Root, as well as offering the MOC-9 module or MOC-C App for Root to their potential customers as an additional option to implement their technology.

Pain relief is a major concern of all developed countries while pain assessment has historically been subjective, time-consuming due to its manual nature, and intermittent. To address these limitations, Mdoloris has developed ANI technology to provide an objective, noninvasive, and continuous way to automatically monitor the pain level of patients. Use of the ANI may help clinicians improve pain assessment and through it, patient care and pain management with more objective and precise drug administration.

"We are proud to announce our first MOC partnership and expect Root's advanced patient monitoring and versatile connectivity options will be strengthened through MOC development and the addition of innovative new technologies such as ANI from Mdoloris," said Joe Kiani, Founder and CEO of Masimo. "We believe that Root with Masimo Open Connect can do for patient monitoring what the PC did for computing: speed up the patient monitoring innovation cycle, reduce the cost of patient monitoring, and prolong the useful life of the equipment hospitals invest in."

"We consider Masimo to be the most innovative company in the patient monitoring space, so it is a pleasure to announce our MOC partnership. We share Masimo's vision of improving patient outcomes and reducing the cost of care and believe Root offers a unique and compelling solution to implement our ANI technology," said Fabien Pagniez, Founder and CEO of Mdoloris Medical Systems.

The ANI MOC-9 module for Root will be available for preview in the Mdoloris exhibit booth at the European Society of Anaesthesiology in Geneva, Switzerland, June 3 to 5, 2017.

ANI has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

About Mdoloris Medical Systems
Mdoloris (www.mdoloris.com), a medical devices manufacturer, was created in June 2010 out of 23 years of academic research performed in Lille University hospital, France. It has an international representation in more than 58 countries and a scientific, technical and medical acknowledgement. Mdoloris has developed so far three products, all able to continuously assess the pain level of patients (The ANI technology for patients older than two years old, the NIPE technology for neonates, the PTA technology for pets). Its innovative technologies provide clinical added values for clinicians that are not able to communicate with their patients in order to personalize pain medications and avoid known side effects due to over / under dosage of such drugs.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

ORi has not received 510(k) clearance and is not available for sale in the United States.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Open Connect™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Open Connect, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Antoine Szczypa
Mdoloris
Email: Antoine.szczypa@mdoloris.com

Potential MOC Partners
Visit: http://www.masimo.com/home/signal-extraction-pulse-oximetry/masimo-set-monitors/root/moc-9-web-form/

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance of O3™ Regional Oximetry for Pediatric Patients



Masimo O3™ Regional Oximetry Pediatric (top) and Adult (bottom) Sensors

Irvine, California – May 30, 2017 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for the pediatric indication for O3™ regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With the clearance of the O3 pediatric sensor, O3 regional oximetry monitoring, which was already available for adult patients in the United States, is now also available for pediatric patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1

"O3 regional oximetry provides access to valuable data about cerebral oxygen saturation," said Joe Kiani, Founder and CEO of Masimo. "With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively,2 without controlling CO2, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old."2

In addition, Masimo O3 regional oximetry and SedLine® brain function monitoring are both available on a single platform, Masimo Root® – opening up a path to better understanding of the brain.

@MasimoInnovates || #Masimo

References
1. Booth, Dukatz, Ausman, and Wider. Cerebral and somatic venous oximetry in adults and infants. Surg. Neurol Int. 2010; 1: 75.
2. Masimo data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3™ regional oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 regional oximetry, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces the Full Market Release of Early Warning Score (EWS) with the Root® Patient Monitoring and Connectivity Hub

Irvine, California – May 19, 2017 – Masimo (NASDAQ: MASI) announced today the full market release of Early Warning Score (EWS) on the Root® patient monitoring and connectivity hub. EWS aggregates information from multiple vital signs and clinical observations to generate a score that represents the potential degree of patient deterioration.

Root, which works in conjunction with Radical-7® or Radius-7® Pulse CO-Oximeters® and Masimo Open Connect™ (MOC-9™) measurements, features Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, rainbow SET™ pulse CO-Oximetry, NomoLine™ capnography and gas monitoring, SedLine® brain function monitoring, O3™ regional oximetry, and SunTech® blood pressure and Welch Allyn® temperature monitoring. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1, including at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2



Masimo Root® with Early Warning Score (EWS)

Patient data from Radical-7 or Radius-7 and data collected using Root and other connected Masimo and third-party devices can be shared with Masimo Patient SafetyNet™*, providing hospital-wide remote monitoring and clinician notification, as well as the ability to automatically transfer patient data to a hospital's Electronic Medical Record (EMR). Each time a clinician transfers data to the EMR via Root connected to Patient SafetyNet, an Early Warning Score (EWS) can now be included. Clinicians can also choose to have the standalone Root, not connected to Patient SafetyNet, perform EWS calculations, helping assist spot-check-based nursing workflows.

Early warning scores are based on multiple contributors, including vital signs such as oxygen saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure – and contributors entered by clinicians, such as level of consciousness, use of supplemental oxygen, and urine output. The weighting and number of contributors differ depending upon which EWS protocol is used. Root can be customized for various predefined EWS protocols, or hospitals can configure their own set of required contributors, and their relative weights, to create an EWS unique to their care environment.

"Root, from its versatile connectivity options to its advanced patient monitoring, from rainbow® SpHb® to SET® SpO2, helps hospitals improve patient care. We hope the addition of Early Warning Score to Root will help automate a potentially valuable calculation and streamline its inclusion in EMRs," said Joe Kiani, Founder and CEO of Masimo.

EWS is a convenient aid to clinical assessment and not a substitute for clinical judgment.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Midmark, Masimo Announce Partnership to Improve Vital Signs Acquisition

DAYTON, Ohio, May 15, 2017 – Midmark Corporation, a leading medical solutions provider for ambulatory care, and Masimo (NASDAQ: MASI), a global leader in innovative noninvasive monitoring technologies, today announced a partnership focused on improving the accuracy and efficiency of vital signs acquisition in the clinical space.

With this partnership, Masimo SET® pulse oximetry technology is now an available option with Midmark's recently introduced Midmark IQvitals® Zone™, the industry's first monitoring device to feature Bluetooth® low energy technology for auto-connecting during the vitals acquisition process. IQvitals Zone devices equipped with Masimo SET® technology provide clinicians with accurate, real-time vitals sign information including oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi) to facilitate timely clinical decisions.

Midmark IQvitals Zone changes the traditional workflow in vitals acquisition by establishing a direct wireless connection between vital signs measurement and the caregiver's tablet or laptop. The vital signs monitor automatically connects with the appropriate equipment when the caregiver places a tablet or laptop on the multi-use work surface or near the monitoring device and initiates vitals acquisition. When the equipment is connected, caregivers can take patient vitals, review results and seamlessly import the information to an electronic medical records (EMR) system directly from their laptop or tablet.

"Masimo has long been a leader in creating new technologies to improve patient care," said Kurt Forsthoefel, Marketing Director, Medical Products and Services, Midmark. "Midmark and Masimo are two companies ultimately focused on improving outcomes and the healthcare experience, and we're looking forward to working together to provide caregivers with innovative technologies that enhance patient-caregiver interaction and improve outcomes at the point of care."

"Like Midmark, Masimo is focused on developing solutions which can help caregivers enhance the quality and process of care," said Rick Fishel, President of Worldwide OEM Business and Strategic Development for Masimo. "We are confident that Masimo's proven portfolio of accurate and timely measurements, in combination with Midmark's innovative solutions, will help physicians and caregivers deliver quality care and enhance clinical work flow."

The Midmark IQvitals Zone device with Masimo SET pulse oximetry technology is one part of a fully connected point of care ecosystem that promotes well-coordinated patient experiences. More information about how IQvitals Zone brings the industry one step closer to a connected ecosystem can be found in the new white paper, "Zone Technology: Connecting Vitals Acquisition within the Point of Care Ecosystem" in the Midmark content and news library.  

 

The study was supported by research grants from Masimo to Loma Linda University, Mayo Clinic in Florida, and the University of California, Irvine.

@MasimoInnovates || #Masimo

About Midmark
Midmark Corporation, a privately held company founded in 1915, is a leading provider of medical, dental and veterinary equipment and technologies. Our nearly 1,700 teammates worldwide are passionate, courageous leaders focused on making a positive difference in the lives we touch by improving the experience between patients and their caregivers. Headquartered in Dayton, Ohio, Midmark maintains production and administrative offices in Versailles, Ohio, as well as seven other locations in the United States and international subsidiaries in India, Italy and the United Kingdom. To learn more about Midmark, visit midmark.com.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Contacts:
Meghann Naveau
Content & Social Media Manager
Midmark Corporation
Phone: (937) 281-7609
Email: mnaveau@midmark.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Multicenter Study at UC Davis, UC Los Angeles, and Mayo Clinic Evaluates the Trend Accuracy of Masimo Continuous SpHb®

Washington, DC – May 15, 2017 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the International Anesthesia Research Society (IARS) Annual Meeting in Washington, DC. In the multicenter study, researchers at three academic medical centers evaluated the trend accuracy of noninvasive, continuous hemoglobin monitoring (SpHb®).1

The prospective observational study was a collaboration among Drs. Richard Applegate and Patricia Applegate of the University of California, Davis; Dr. Maxime Cannesson of the University of California, Los Angeles; and Drs. Prith Peiris, Beth Ladlie, and Klaus Torp of the Mayo Clinic in Jacksonville, Florida.

The researchers enrolled 135 adult patients who were scheduled for surgery with planned arterial catheter placement and continuous SpHb monitoring. Each time a blood sample was obtained, the researchers recorded SpHb using a Masimo Radical-7® Pulse CO-Oximeter® with Masimo rainbow® disposable R125 sensors (Revision K; same algorithm as Revision L). They also analyzed each blood sample twice to determine clinical laboratory hemoglobin (tHb; Sysmex 550 or Coulter LH 750), arterial blood gas CO-oximeter hemoglobin (ABGHb; Radiometer ABL800, Nova Biomedical CCX or PhOX, or Siemens RAPIDLab 1265), and point-of-care hemoglobin (aHQHb; HemoCue HB 301).

To assess overall trend accuracy and trend accuracy within defined ranges, the researchers analyzed the correlation of change in tHb to changes in SpHb, ABGHb, and aHQHb. Trend bias within 10% of tHb was considered clinically equivalent. The researchers found that "The confidence intervals for the proportion of samples with trend bias within 10% of tHb overlapped for SpHb (372 of 416 trends; 89.4%; 86.1% to 92.2%), ABGHb (391 of 416 trends; 94.0%; 91.3 to 95.9%) and aHQHb (406 of 416 trends; 97.6%; 95.6 to 98.7%)."

The researchers concluded that "SpHb, ABGHb and aHQHb appear to provide similar intraoperative guidance regarding tHb increase or decrease. Continuous noninvasive SpHb changes larger than ± 0.5 g/dL could provide a reasonable indication for the clinician to obtain a confirmatory blood sample for Hb measurement, but not replace such measurement in guiding transfusion decision making. The transfusion impact of continuous hemoglobin trend monitoring should be studied."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

The study was supported by research grants from Masimo to Loma Linda University, Mayo Clinic in Florida, and the University of California, Irvine.

@MasimoInnovates || #Masimo

Reference
1. Applegate R, Cannesson M, Applegate P, Peiris P, Ladlie B, and Torp K. Hemoglobin Change Measurement Accuracy Obtained from 3 Devices During Surgery. Proceedings from the 2017 IARS Annual Meeting, Washington, DC. Abstract #A1786.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Introduces Rad-G™ Pulse Oximeter

Irvine, California – May 9, 2017 – Masimo (NASDAQ: MASI) today announced the introduction of Rad-G™, a combined pulse oximeter designed primarily for use in pneumonia screening and spot-checking of oxygen saturation (SpO2) in low-resource settings. The development of the device is supported in part by a grant of $4.95 million from the Bill and Melinda Gates Foundation (BMGF), announced in November 2016, as part of a partnership with Masimo to facilitate screening for pneumonia by health workers in low-resource areas.



Masimo Rad-G™ Pulse Oximeter

Rad-G is a low-cost, rugged, handheld pulse oximetry device with a rechargeable battery and LCD display. It uses Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry technology to measure SpO2, respiration rate from the Pleth (RRp™), pulse rate (PR), and perfusion index (Pi).

Pneumonia remains the single largest treatable infectious cause of death in children worldwide, causing over 900,000 deaths each year among children under 5 years of age.1 In a study funded by the BMGF Diagnostics Modelling Consortium, the researchers concluded that in settings where supplemental oxygen is available, the addition of pulse oximetry to standard integrated management of child illness protocols could reduce pneumonia mortality rates.2 More recently, the World Health Organization (WHO) has been conducting a multi-country evaluation of enhanced community case management of pneumonia with the use of Masimo SET® pulse oximetry by community health workers.3

Enhancing patient screening is critically important to reducing the global burden of pneumonia. Moreover, enhanced screening may empower healthcare providers by supporting informed decisions related to pneumonia diagnosis and treatment, with the appropriate administration of antibiotics and oxygen therapy when needed. Masimo and BMGF hope that Masimo pulse oximetry technology, already used to monitor approximately 100 million patients around the world, can help better screen children in even the most challenging conditions.

Joe Kiani, Founder and CEO of Masimo, said, "The introduction of the Rad-G is a critical milestone in our partnership with the Bill and Melinda Gates Foundation to help improve pneumonia screening. We are grateful to have the opportunity to bring our proven SET® pulse oximetry technology to areas of the world that are in desperate need of better healthcare, and look forward to making a positive difference in the lives of many children."

Rad-G is currently not available for sale in the United States, Canada, or the E.U.

@MasimoInnovates || #Masimo

References
1. Pneumonia Fact Sheet, World Health Organization (WHO), September 2016. http://www.who.int/mediacentre/factsheefts/fs331/en/.
2. Floyd J et al. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528(7580):S53-9.
3. World Health Organization (WHO), 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-G™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-G, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Two Fire Rescue Departments Honored for Excellence in Emergency Medical Services

Fire Service-Based EMS Awards Presented at 29th Annual National Fire and Emergency Services Dinner

Washington DC and Irvine, California – April 11, 2017 – Masimo (NASDAQ: MASI) announced today that the Congressional Fire Services Institute (CFSI) has honored the Orange County (Florida) Fire Rescue Department and the Montgomery County (Maryland) Fire & Rescue Service with the Excellence in Fire Service-Based EMS Award for best practices and innovative solutions in the delivery of emergency medical services. The awards presentation took place on April 6th in Washington, DC. Masimo is proud to be a co-sponsor of this award.

Orange County (Florida) Fire Rescue Department

The Orange County Fire Rescue Department was awarded the Excellence in Fire Service-Based EMS Award in recognition of the development of two best practices. The first is the Sepsis Alert Program, which educates EMS providers to better identify potential cases of severe sepsis among patients in pre-hospital settings, as early recognition and treatment may improve patient outcomes and lessen the financial impact of prolonged hospital stays. The program is modeled after similar "alert" programs that trigger EMS responders to initiate certain procedures, such as programs designed to recognize signs of stroke and cardiac arrest. Preliminary results since establishing the Sepsis Alert Program have included reductions in time to blood culture, time to administer antibiotics, time to administer fluids, length of hospital stay, and percentage admitted to the ICU.

The other best practice, the Paramedic Preceptor Academy, was developed to increase pass rates for Orange County's new paramedics, as well as to improve training and continuing education opportunities identified through the department's quality assurance process. As a result of the improved and standardized training, in the first year of the program first-time pass rates on written and practical assessments have increased dramatically. Several other central Florida fire departments are now also participating in the Paramedic Preceptor Academy, in the hopes of seeing similar results.

Montgomery County (Maryland) Fire & Rescue Service

The Montgomery County Fire & Rescue Service was awarded the Excellence in Fire Service-Based EMS Award in recognition of the creation of an outreach initiative called Montgomery County Non-Emergency Invention and Community Care Coordination (MCNIC3). Montgomery County developed MCNIC3 to address the disparity between the volume of emergency 911 calls, which continues to grow, and EMS resources, which have stayed relatively flat. Much of the growth in 911 calls is a result of low-priority calls from frequent 911 users. MCNIC3 targets these frequent 911 users and attempts to connect them with a variety of community-based medical and social programs, in an effort to better meet their ongoing healthcare needs without taking emergency care away from those with true emergency needs. Firefighters and EMS providers are able to refer any patient they encounter to the MCNIC3 program. By partnering with local hospitals, the health department, and various community groups, MCNIC3 can arrange periodic in-person visits to ensure that the patients' healthcare needs are being met without straining county resources. To date, MCNIC3 has reduced calls for emergency service from those patients enrolled in the program by 55%. There are plans to expand the scope of the program and develop additional community partnerships.

"CFSI takes great pride in co-sponsoring the Excellence in Fire Service-Based EMS Awards with Masimo," said Dr. William F. Jenaway, Ph.D., President of CFSI. "Through this awards program, we are able to recognize innovations in the delivery of emergency medical services throughout the nation. The recipients of the 2017 award, Orange and Montgomery Counties, certainly demonstrated themselves worthy of this recognition by developing outstanding new programs that improve training, distribute resources more wisely, and ultimately improve patient outcomes. We hope other departments around the country will be inspired to introduce similar innovations."

"Firefighters and emergency services personnel are our heroes. In saving lives, they put their own on the line for us every day. It's crucial they have the training and resources they need to provide the best care for those they protect. Recognizing the possibility of and intervening to address sepsis as soon as possible, for example, can significantly improve patient outcomes," said Joe Kiani, Founder and CEO of Masimo. "Masimo is honored to co-sponsor this awards program with CFSI and to recognize Orange and Montgomery Counties for their innovative achievements."

Approximately 1,600 fire and emergency services leaders attended the 29th Annual National Fire and Emergency Services Dinner to pay tribute to the dedication and commitment of the nation's fire and emergency services providers. Hosted by CFSI, the annual dinner benefits the mission of the non-profit policy organization, which is designed to educate members of Congress about fire and life safety issues. This year's honored speakers were four co-chairs of the Congressional Fire Services Caucus: Senator Susan Collins (ME), Senator Tom Carper (DE), Congressman Steny Hoyer (MD05) and Congressman Bill Pascrell (NJ09).

The Excellence in Fire Service-Based EMS Awards Program was established in 2010 to recognize volunteer, career, and combination fire departments for excellence in and enhancements to the delivery of emergency medical services. By showcasing their best practices, the awards program provides ideas for other fire departments to consider implementing as they seek to improve their fire service-based EMS systems.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion** were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Kite™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Kite, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

CFSI
Bill Webb, Executive Director
Phone: (202)-371-1277
Email: bwebb@cfsi.org

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Full Market Release of Root® Patient Monitor and Connectivity Hub with Kite Supplemental Display System

Irvine, California – April 10, 2017 – Masimo (NASDAQ: MASI) announced today the full market release of Root® with Kite, a supplemental display system. Kite expands visibility of patient data for clinicians by allowing data from Root to be viewed on bigger screens, in customized configurations, in operating rooms, cardiac theaters, emergency rooms, and other venues.

Kite connects to Root via a wired or wireless connection on the same IP network and displays monitoring data from the connected device on a smart TV. Data from devices connected to Root – including the Radical-7® Pulse CO-Oximeter®, the wearable, tetherless Radius-7® Pulse CO-Oximeter, and optional monitoring modules such as SedLine® Brain Function Monitoring, O3 Regional Oximetry, and ISA capnography solutions – can also be simultaneously displayed on a supplemental screen using Kite. The Kite supplementary display system can be customized to enable clinicians to view the monitoring parameters, waveforms, and other data they require for that patient and type of care or operation.



Masimo Root® Patient Monitor and Connectivity Hub with Kite Supplemental Display System

Masimo bedside monitoring devices provide clinicians with many types of data. During complex care, monitoring might involve so many different forms of real-time output, all of value to clinicians, that displaying them simultaneously on the primary device's smaller display may be inconvenient or impractical. With Kite, that data can be conveniently displayed on a large, easy-to-read monitor, relayed from the point-of-care device. For example, during endoscopy, while a patient is anesthetized, clinicians may wish to monitor with SedLine, for brain function, with rainbow Acoustic Monitoring® (RAM), for respiration, and with ISA capnography, for end-tidal carbon dioxide, in addition to pulse oximetry and blood pressure. With Kite, the multiple data outputs from each of these types of monitoring can be simultaneously displayed on a large, centrally-located screen, in the clinicians' preferred configuration.

Dr. Don Marketto, D.O., Anesthesiologist, Mountain View Regional Hospital, Las Cruces, New Mexico, noted, "Masimo software made it extremely easy to adjust the placement and size of the information on the screen to the satisfaction of both the surgeon and anesthesiologist." Joseph Bremer, a perfusionist at Mountain View Regional Hospital, added, "Kite greatly enhanced the visibility of the Masimo monitor. During bypass I could easily view cerebral blood flow allowing time to validate adequate perfusion to my patient and maintain my attention on my bypass circuit."

"Kite showcases the versatility and flexibility of Root," said Joe Kiani, Founder and CEO of Masimo. "Our goal is to minimize clinician distraction and maximize focus on the patient and relevant data."

A promotional Kite opportunity is available for new and existing Masimo Root and Radical-7 customers.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion** were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Kite. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Kite, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Massena Memorial Hospital of New York Adopts Masimo Root® and Masimo Patient SafetyNet

Hospital-Wide Supplemental Monitoring and Remote Clinician Notification System Automates Documentation of Patient Data

Massena, New York and Irvine, California – March 27, 2017 – Masimo (NASDAQ: MASI) announced today that Massena Memorial Hospital (MMH) of Massena, New York, has adopted Masimo Root® and Patient SafetyNet*. The hospital is integrating Root with wearable rainbow SET Pulse CO-Oximeter® Radius-7® and Patient SafetyNet to implement a wireless monitoring, patient data automation, and supplemental remote clinician notification system that will be used in all medical-surgical units.

Masimo Patient SafetyNet is a supplemental remote monitoring and clinical notification system that enables information from bedside and tetherless wearable (when used with Radius-7) monitors, which use Masimo SET® and rainbow® noninvasive blood constituent monitoring technologies, to be accessible from different locations than patients, and relays alarm notifications to clinicians, wherever they may be. Masimo Measure-through Motion and Low Perfusion SET® pulse oximetry addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry, and has been shown to significantly reduce false alarms and increase true alarm detection,1 helping allow clinicians to focus on the patients and alarms that need the most attention. In 2016, Dartmouth-Hitchcock Medical Center, which has been using Masimo SET® pulse oximetry and Patient SafetyNet as part of a comprehensive alarm management strategy in all medical-surgical units for ten years, reported achieving a 50% reduction in unplanned ICU transfers and a 60% reduction in rescue events over those ten years, despite increases in patient acuity and occupany.2

Another important feature to MMH is the ability of Root, in conjunction with Patient SafetyNet, to automate the transfer of patient vital signs, including temperature and blood pressure, to the hospital's Electronic Medical Record (EMR) system, which may help improve nursing workflows.

"The Masimo vital sign monitoring system will provide many benefits to the patients and staff of the Medical/Surgical/Pediatric unit," said Lisa Susice, MSN, RN, ICU/Med-Surg/Pediatric Nursing Director, MMH. "To be able to combine the ability to monitor our active patients in medical-surgical units reliably with the time-saving ability to transmit pulse rate, temperature, blood pressure, breathing rate, and oxygen saturation values automatically into the patients' electronic medical records allows our nurses to spend more time nursing our patients, instead of scribing and potentially being delayed in responding to patient alarms. Our staff, who have previously had to manually transcribe the information from the vital sign machine to a paper record, then eventually key it into the electronic record, will save many steps. Additionally, staff will be able to have a quick, real-time glance at each connected patient's pulse, respirations, and oxygen saturation from monitors strategically placed throughout the floor."

Ralene North, Chief Nursing Officer, MMH, added, "We are again excited to invest in technology that is focused on patient safety and will improve the working conditions of our nurses. The less time a nurse spends dealing with false alarms or entering data into the system, the more time that can be spent at the bedside attending to the personal and educational needs of the patient."

Root with Noninvasive Blood Pressure and Temperature is available with Radical-7® or Radius-7 Pulse CO-Oximeters. Radius-7 provides continuous tetherless wearable monitoring so that patients can have freedom of movement while being monitored. Monitoring parameters from Radical-7 or Radius-7 are sent to Patient SafetyNet through Root, allowing for hospital-wide remote monitoring, automated documentation of patient data in the EMR, and supplemental remote clinician notification of alerts and alarms.

"Massena Memorial Hospital has long been a valued Masimo customer, and with this additional investment, they are continuing to focus on patient safety," stated Joe Kiani, Founder and CEO of Masimo. "Continuous monitoring in the post-surgical ward has been shown to reduce preventable death.3 In addition, automating the transmission of vital signs data can help to improve workflow and reduce incomplete and erroneous medical records. We applaud Massena Memorial Hospital for leading the way in patient safety."

MMH is a full-service 50-bed acute-care community hospital located in northern New York with a medical staff of over 50 physicians in over 15 specialties. With more than 400 healthcare employees and 6 outreach clinics, MMH is the second largest employer in the town of Massena.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Shah N et al. Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers. J Clin Anesth. 2012 Aug;24(5):385-91.
2. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
3. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Rad-97 Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure

Neuchatel, Switzerland – March 20, 2017 – Masimo (NASDAQ: MASI) announced today the CE marking of noninvasive blood pressure (NIBP) measurements for the Rad-97 Pulse CO-Oximeter® and connectivity hub. Rad-97 offers Measure-through Motion and Low Perfusion SET® pulse oximetry and upgradeable rainbow® noninvasive blood constituent monitoring technology in a compact standalone monitor configuration which can also collect and remotely transmit data from connected devices.

Rad-97 with NIBP enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three measurement modes: spot-check, automatic interval (which measures blood pressure routinely, at a desired interval), and stat interval (which continually measures blood pressure for a desired duration). An integrated port allows clinicians to connect a blood pressure cuff inflation hose directly to Rad-97, and is compatible with both disposable and reusable cuffs, for a variety of patient types, designed for reliability and patient comfort.



Masimo Rad-97™ Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure

With the addition of NIBP to Rad-97, clinicians can easily and automatically chart blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin, and other noninvasive parameters. In hospital settings and when used in conjunction with Masimo Iris Gateway™ or Patient SafetyNet™*, data from Rad-97 and other devices connected via the Iris™ hub can be sent directly to the patient's electronic medical record (EMR). With Patient SafetyNet, alarms and alerts from connected devices are seamlessly forwarded to clinicians.

Rad-97 includes built-in wireless connectivity, via Wi-Fi and Bluetooth®. Using Bluetooth or a wired USB connection, Rad-97 can connect to nearby devices, such as glucometers and weight scales, and can allow the data from the connected device to be transmitted remotely. Rad-97 will be available for use on home and enterprise networks to connect to remote monitoring systems, including Patient SafetyNet. Additional devices can be simultaneously attached to Rad-97 using the Iris hub.

Rad-97 features a high-resolution, 1080p HD color display with user-friendly multi-touch navigation, allowing clinicians to easily customize the device to best suit their monitoring and viewing needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed. An optional roll stand allows for tetherless device transport, offering additional flexibility when space is limited.

Rad-97 will also be available with an optional camera, which can be used in conjunction with Masimo Patient SafetyNet. The camera will provide a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. When used at home, camera-equipped Rad-97 will allow patients and clinicians to interact remotely, making it well-suited as a point-of-care device for potential telehealth applications.

Like Radical-7®, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements PVi®, total hemoglobin (SpHb®), methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), and oxygen content (SpOC). Additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp™) are also available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

"Rad-97 brings our core SET® and rainbow® technologies to a compact design, which allows broader applications in many new settings, including the home, with its hub and telepresence capabilities," said Joe Kiani, Founder and CEO of Masimo. "We're excited to extend its range of possibilities with the addition of integrated blood pressure measurement."

Rad-97 is not available in the United States.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,6,7 and when used with PVi, a reduction in 30-day mortality was observed.8 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-97®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates the Utility of Masimo SpHb® Monitoring During Liver Transplantation

Irvine, California – March 13, 2017 – Masimo (NASDAQ: MASI) announced today the publication of a recent study conducted on adult patients undergoing liver transplantation (LT), in which researchers assessed the accuracy and trending ability of noninvasive Masimo SpHb® (total hemoglobin) measurement, as compared to conventional laboratory hemoglobin (HbL) measurements. The researchers found that SpHb had "clinically acceptable accuracy of hemoglobin measurement [compared] with a standard laboratory device when used during LT" and that "[t]his technology can be useful as a trend monitor during all surgical phases of LT and can supplement HbL to optimize transfusion decisions or to detect occult bleeding."1

Monitoring a patient's hemoglobin (Hb) levels is essential during LT because, as the researchers point out, "a serious loss of blood and fluid shift causes great variations [in] the Hb level, and delayed blood transfusion may cause graft dysfunction because of hypo-perfusion and tissue hypoxia. Moreover, more importantly, over-transfusion is associated with end organ damage and graft dysfunction." Recognizing that the "benefits and clinical advantages of noninvasive, rapid, and accurate determination of Hb in the operating room are obvious," Dr. Kayhan and colleagues sought to evaluate the accuracy and trending ability of Masimo SpHb during LT by comparing its measurements to those of a standard laboratory hematology analyzer.

To this end, the investigators enrolled fifty-five adult patients undergoing orthotopic LT in the study. The patients' Hb levels were analyzed using a Beckman Coulter LH 780 Hematology Analyzer, with each patient's arterial blood being sampled six times, twice during each of the three phases of the surgery: pre-anhepatic, anhepatic, and neohepatic. SpHb values were recorded within 10 seconds of each blood sample using a Masimo Radical-7® Pulse CO-Oximeter® (software version 7.8.0.1) and Masimo rainbow® ReSposable R2-25r and R2-25a sensors. A total of 282 paired measurements were collected and analyzed. HbL values ranged from 5.4 to 17.1 g/dL (mean 10.58) and SpHb values ranged from 6.9 to 17.7 g/dL (mean 11.44).

To compare the accuracies of the two methods, the researchers used a Bland-Altman plot and calculated absolute bias (the differences between SpHb and HbL) of 0.86 (95% CI = 0.50-1.21), precision (one standard deviation of the bias) of 1.58, and limits of agreement of -2.25 to 3.96. Using Pearson's correlation analysis, the researchers found that the correlation between the two sets of values was "highly significant": Pearson's correlation coefficient r=0.73; 95% confidence interval = 0.67-0.78, R2=0.53, p less than 0.001.

The researchers concluded that "[t]he results of this study show that SpHb has clinically acceptable accuracy of Hb measurement as compared with a standard laboratory device when used during LT. This technology may provide more timely information on Hb status than intermittent blood sample analysis and thus has the potential to improve blood management during LT. The trending accuracy may not only detect occult bleeding but can also prevent over-transfusion after bleeding; at least this method has the potential to supplement detection of changes. Nevertheless, due to underestimation in the lower Hb values, clinicians should be cautious when making decisions based on SpHb alone. Instead of focusing on a single value, SpHb may be considered an early warning system and a trend monitor. Future studies should evaluate the utility of SpHb in terms of overall clinical outcomes of transfusion decision."

"In prior studies using SpHb monitoring, reductions in blood transfusion were observed,2,3,4 and when used with PVi®, another Masimo noninvasive measurement, a reduction in 30-day mortality was observed5," stated Joe Kiani, Founder and CEO of Masimo. "Dr. Kayhan's study adds to the evidence that SpHb may be a useful tool during procedures such as liver transplantation."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samples. SpHb monitoring is intended to supplement, not replace, laboratory measurements. Blood samples should be analyzed by laboratory instruments when possible prior to clinical decision making.

@MasimoInnovates || #Masimo

References
1. Kayhan et al. Accuracy of Noninvasive Hemoglobin Monitoring by Pulse CO-Oximeter During Liver Transplantation. Minerva Anestesiologica. 2017 Jan 20. DOI: 10.23736/S0375-9393.17.11652-4
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong, 2016. Abstract #PR607.
5. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,6,7 and when used with PVi, a reduction in 30-day mortality was observed.8 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Availability of the RD SedLine® Adult EEG Sensor

Irvine, California – March 6, 2017 – Masimo (NASDAQ: MASI) announced today availability of the RD SedLine® EEG sensor, for use with Masimo SedLine Brain Function Monitoring and compatible with simultaneous use of Masimo O3 Regional Oximetry. SedLine and O3 provide simultaneous monitoring on the Masimo Root® monitoring platform, helping to give clinicians more information about the brain.



Masimo RD SedLine® Adult EEG Sensor

The RD SedLine EEG sensor features a repositioned, color-coded sensor-cable connection that lies comfortably on the patient's head and soft foam pads to reduce discomfort upon application to the patient. The sensor's streamlined shape and built-in fitting guide allow simultaneous application of SedLine and O3 sensors. The sensor's performance and specifications remain the same and work with existing SedLine modules, via an updated patient cable.

SedLine brain function monitoring features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, four EEG waveforms, a Density Spectral Array (DSA; an easy-to-interpret, high-resolution display of bi-hemispheric activity and EEG power), and the Patient State Index (PSI; a processed EEG parameter related to the effect of anesthetic agents). Next Generation SedLine, available outside the U.S., enhances the PSI to make it less susceptible to electromyographic (EMG) interference and to improve performance in low-power EEG cases.

Masimo RD SedLine Adult EEG and O3 Regional Oximetry Sensors

Masimo RD SedLine® Adult EEG and O3 Regional Oximetry Sensors

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.

Dr. David Drover, Professor of Anesthesiology in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Hospital, stated, "The RD SedLine sensor allows simultaneous application with O3 Regional Oximetry to deliver more information about my patient's brain in a single specialty monitor."

"Root with SedLine and O3 presents a powerful brain monitoring solution," said Joe Kiani, Founder and CEO of Masimo. "With the addition of the RD SedLine EEG sensor, the EEG and optical sensors fit together like puzzle pieces, making it easier for clinicians to simultaneously monitor patients with both technologies, while providing a comfortable experience for the patient."

The RD SedLine EEG sensor is available in the U.S. Next Generation SedLine does not have 510(k) clearance and is not available in the U.S.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®, RD SedLine EEG sensors, and O3. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine, RD SedLine EEG sensors, and O3, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Assesses the Utility of Masimo PVi® Monitoring During Colorectal Surgery

Neuchatel, Switzerland – February 27, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recent study conducted on low-risk patients undergoing colorectal surgery, in which researchers assessed the utility of noninvasive and continuous Masimo PVi® (Pleth Variability Index) monitoring to guide fluid management, as compared to esophageal Doppler, an invasive method. The researchers found no significant difference between the two technologies in mean total fluid administered and concluded that "PVi offers an entirely noninvasive alternative for goal-directed therapy in this group of patients."1

In the study, Dr. Warnakulasuriya and colleagues at York Teaching Hospital in York, United Kingdom, evaluated the performance of Masimo PVi monitoring in guiding fluid management, as compared to that of an established technology, esophageal Doppler. Forty low-risk patients undergoing elective colorectal surgery were enrolled in the study. The patients were randomly assigned to two groups, with each group having fluid therapy directed by one of the two technologies. The researchers measured the absolute volume of fluid given intraoperatively and fluid volume at 24 hours. The researchers found "no significant difference between PVi and esophageal Doppler groups in mean total fluid administered (1286 vs 1520 ml, p=.300) or mean intraoperative fluid balance (+839 v + 1145 mL, p=.150)."

The researchers concluded that "amongst fit patients undergoing major colorectal surgery there was no significant difference in the volume of fluid administered when targeted by noninvasive PVi technology compared to a stroke volume maximization technique using esophageal Doppler. There was no significant difference in postoperative outcomes between the groups. Therefore, PVi offers a noninvasive, consumable free alternative for intraoperative fluid optimization in fit patients undergoing major colorectal surgery, where intraoperative goal-directed therapy is deemed a standard of care but there is no requirement for arterial cannulation."

PVi is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In other clinical studies, PVi has been shown to provide benefits in the monitoring of mechanically-ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVi as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9 In a study in which PVi was used in conjunction with Masimo SpHb® (noninvasive hemoglobin measurement), the technologies were shown to reduce mortality at 30 and 90 days.10

"Clinical evidence for the utility of Masimo PVi continues to amass," said Joe Kiani, Founder and CEO of Masimo. "Dr. Warnakulasuriya's study provides additional information about the benefits of PVi. We are grateful for the opportunity we have to continue to improve patient outcomes and reduce cost of care with our innovative noninvasive monitoring."

@MasimoInnovates || #Masimo

References
1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608.
2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6.
3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T et al. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011;39(2):294-299.
7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91.
8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 May 14:634-639.
9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Recent Study Monitoring Methemoglobin Levels During Administration of Inhaled Nitric Oxide

Irvine, California – February 21, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recent study conducted on children admitted to a Ugandan hospital with fever and malaria, in which Masimo's noninvasive measurement SpMet® was used to monitor methemoglobin (MetHb) levels. One group of children with severe malaria was selected to receive inhaled nitric oxide (iNO) treatment as an adjunct to intravenous therapy while a placebo group received room air. Both of these groups were monitored with SpMet.1

Red blood cells containing hemoglobin can become oxidized in the precence of certain drugs and compounds, including nitric oxide, changing it to methemoglobin (MetHb), which impairs the oxygen-carrying capacity of blood. When MetHb levels rise, headache, respiratory distress, cyanosis, and finally death may occur. A 2004 study conducted at Johns Hopkins Hospital reported that 20% of the patients tested, from neonates to geriatrics, had elevated MetHB caused by the side effects of 40 drugs given to patients in hospitals, including nitric oxide. Three patients nearly died and one patient died from elevated MetHb during the study period.2

An estimated 1.2 million people die from malaria annually worldwide, with a mortality rate of 8-20% in children with severe malaria.3 In the Ugandan study, Dr. Andrea Conroy and colleagues at Jinja Regional Referral Hospital assessed an adjunctive therapy for malarial patients: the administration of inhaled nitric oxide (iNO) – but as iNO is absorbed by the body, it "induces MetHb in a dose-dependent manner." Noting that "[t]here are no reliable estimates of methemoglobinemia in low resource clinical settings," but seeking to "evalulate whether iNO could improve clinical recovery...in a cohort of children with severe malaria," the investigators chose to monitor MetHb levels during treatment with a Masimo Rad-57® Pulse CO-Oximeter® with noninvasive SpMet monitoring.

The investigators in Uganda selected 180 children admitted to the hospital with severe malaria between 2011 and 2013 to receive either iNO (n=88) or a placebo, room air (n=92), in conjunction with standard anti-malarial treatment. MetHb levels were measured on a four-hourly basis following gas initiation, using Masimo SpMet. Between gas initiation and the first check with SpMet, MetHb levels rose from an average of 1.8% to 4.1% for the iNO group but stayed the same (1.7% to 1.8%) in the placebo group. MetHb levels typically plateaued within 12-24 hours of receiving iNO. Gas was withdrawn for 31 children (placebo: 12; iNO: 19; p=0.13).

The researchers stated that "we were able to evaluate the variability in MetHb responses within subjects and the frequency of methemoglobinemia prompting study gas discontinuation. Despite the high doses of iNO administered, study gas was temporarily discontinued only five times for MetHb greater than 10% (all children in the iNO group). We were able to re-start study gas for all children that had a MHb measurement that exceeded 10% once the MetHb returned to less than 7% without having the MetHb exceed 10% again. It was not necessary to wean children off iNO, in contrast to studies administering iNO to neonates with hypoxic respiratory failure, as we did not observe any rebound effects (e.g. worsening oxygenation) following discontinuation of study gas."

The authors concluded that, "Hospitalized children with evidence of impaired oxygen delivery, metabolic acidosis, anemia, or malaria were at risk of methemoglobinemia. However, we demonstrated high-dose iNO could be safely administered to critically ill children with severe malaria with appropriate MHb monitoring."

Joe Kiani, Founder and CEO of Masimo, stated, "It's great to see that our invention of continuous methemoglobin monitoring has allowed these clinicians to study the outcomes of administering iNO treatment. We hope to continue developing monitoring technologies that help to address such public health crises."

SpMet monitoring is not intended to be used as the sole basis for making diagnosis or treatment decisions. It is intended to be used in conjunction with other clinical tools, including signs and symptoms and laboratory blood tests.

@MasimoInnovates || #Masimo

References
1. Conroy et al. Methemoglobin and nitric oxide therapy in Ugandan children hospitalized for febrile illness: results from a prospective cohort study and randomized double-blind placebo-controlled trial. BMC Pediatrics. (2016) 16:177. DOI 10.1186/s12887-016-0719-2.
2. Ash-Bernal et al. Acquired methemoglobinemia: A retrospective series of 138 cases at 2 teaching hospitals. Medicine. October 2004;83(5)265-73. DOI 10.1097/01.md.000141096.00377.3f.
3. Murray et al. Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet. 2012;379(9814):413-31.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpMet®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpMet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Respiration Rate Measurement on MightySat Rx

Masimo MightySat Rx is the First Fingertip Pulse Oximeter to Measure Respiration Rate

Neuchatel, Switzerland – February 15, 2017 – Masimo (NASDAQ: MASI) announced today the the CE marking of the measurement of respiration rate from the pleth (RRp) on the MightySat Rx fingertip pulse oximeter. MightySat Rx is a noninvasive device that measures and displays functional oxygen saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI) with the option to add Pleth Variability Index (PVi®) and now, RRp.

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Masimo MightySat with RRp

Respiration rate, or the number of breaths taken per minute, typically requires manually counting breaths with a timer and then converting to a per minute rate, or being fitted with chest leads or straps that can be inconvenient. With the addition of RRp to MightySat Rx, respiration rate can conveniently be measured using the same fingertip sensor that measures SpO2, PR, PI, and PVi (a measurement of the dynamic changes in PI that occur during the respiratory cycle). RRp is measured only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during certain conditions, such as very irregular breathing and excessive movement.

MightySat Rx is indicated for use with both adult and pediatric patients during both no motion and motion conditions, who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments. It offers a Bluetooth wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements. MightySat Rx features the same Measure-through Motion and Low Perfusion SET® pulse oximetry available in a variety of bedside Masimo and OEM monitors. Masimo SET® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Infection control issues aside, Masimo SET® performance benefits are maximized by choosing the the correct sensor type for the applicable use scenario: adhesive sensors for continuous monitoring, reusable cabled sensors for short-term monitoring and MightySat Rx fingertip oximeters for spot-checks on those who are not moving excessively and do not have very poor perfusion. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1 and is the primary pulse oximetry at top hospitals, including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2

"MightySat Rx is our smallest, most compact pulse oximeter, and as such is particularly versatile, offering the convenience of portability," stated Joe Kiani, Chairman and CEO of Masimo. "We are happy to be able to increase its capability with the addition of RRp, and to continue innovating in the field of mobile monitoring devices for the professional caregiver market."

RRp does not have 510(k) clearance and is not available in the U.S.

@MasimoInnovates || #Masimo

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo MightySat Rx and SET®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo MightySat Rx and SET®, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces the Addition of Early Warning Score to the Root® Patient Monitoring and Connectivity Platform

Neuchatel, Switzerland – February 1, 2017 – Masimo (NASDAQ: MASI) announced today the limited market release of Early Warning Score (EWS) on the Root® patient monitoring and connectivity platform. EWS aggregates information from multiple vital signs and clinical observations to generate a score that represents the potential degree of patient deterioration.

Root, which works in conjunction with Radical-7® or Radius-7® Pulse CO-Oximeters® and Masimo Open Connect (MOC-9) measurements, features Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, rainbow SET pulse CO-Oximetry, Nomoline capnography and gas monitoring, SedLine® brain function monitoring, O3 regional oximetry, and SunTech® blood pressure and Welch Allyn® temperature monitoring. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1 and is the primary pulse oximetry technology at top hospitals, including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2

Patient data from Radical-7 or Radius-7 and data collected using Root and other connected Masimo and third-party devices can be shared with Masimo Patient SafetyNet*, providing hospital-wide remote monitoring and clinician notification, as well as the ability to automatically push patient data to a hospital's Electronic Medical Record (EMR). Each time a clinician pushes data to the EMR via Root connected to Patient SafetyNet, an Early Warning Score (EWS) can now be included. Clinicians can also choose to have the standalone Root perform EWS calculations.

There are several EWS protocols, such as Pediatric Early Warning Score (PEWS), Modified Early Warning Score (MEWS), and National Early Warning Score (NEWS). These various scores require vital signs contributors – such as oxygen saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure – and contributors input by clinicians, such as level of consciousness, use of supplemental oxygen, and urine output. The weighting and number of contributors differ depending upon which EWS protocol is used. Root can be customized for various predefined EWS protocols, or hospitals can configure their own set of required contributors, and their relative weights, to create an EWS unique to their care environment.

Recent peer-reviewed studies, across care areas, have suggested that the use of NEWS may have clinical benefits: Vanamali et al. notes that NEWS is a "useful simple physiological scoring system for assessment and risk management of medical emergency admissions."3 Smith et al. found that an EWS of 5 or greater after laparotomy is associated with adverse outcomes, while recommending that future studies evaluate the ability of EWS to predict and prevent such outcomes.4

Outside the U.S., as part of the Patient SafetyNet platform, Masimo also offers Halo Index. Whereas EWS provides a spot-check score using the NEWS standard, Halo Index presents a dynamic, cumulative trending assessment of global patient status as a single displayed number ranging from 0 to 100. Halo Index uses available Masimo parameters from connected monitoring devices, but is scalable to include additional information from the patient data repository. Masimo designed Halo Index to mimic the systematic approach that expert clinicians use in assessing patient physiologic deterioration, analyzing the patient's history and extracting key vital sign parameter characteristics; increases in a patient's Halo Index may indicate the need for clinicians to more closely assess the patient.

"Root, from its versatile connectivity options to its advanced patient monitoring, from rainbow® SpHb® to SET® SpO2, has long been helping hospitals improve and automate their patient care. Now, with Early Warning Score, Root can help clinicians stay ahead of the care race and transfer their patients home safely," said Joe Kiani, Founder and CEO of Masimo.

Root with Early Warning Score (EWS) and Halo Index are not available in the U.S. EWS is a convenient aid to clinical assessment and not a substitute for clinical judgement.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
3. Vanamali DR, et al. The Role of National Early Warning Score (News) in Medical Emergency-Patients in Indian Scenario: A Prospective Observational Study. Journal of Evolution of Medical and Dental Sciences. 2014; Vol. 3, Issue 13, March 31; Page: 3524-3528, DOI: 10.14260/jemds/2014/2315.
4. Smith, et al. Early warning score: An indicator of adverse outcomes in postoperative patients on a gynecologic oncology service. Gynecol Oncol. 2016 Oct;143(1):105-8. doi: 10.1016/j.ygyno.2016.08.153. Epub 2016 Aug 6.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Reaffirms Commitment to India with Launch of Advanced Monitoring Technologies Made for India

Leading Bangalore Hospital CEOs Convene for Masimo Roundtable

Bangalore, India – January 2, 2017 – Masimo (NASDAQ: MASI) announced today the launch and availability of the Rad-97 Pulse-CO Oximeter®* and Next Generation Sedline®* Brain Function Monitoring in India. The announcement was made in Bangalore by Joe Kiani, Founder and CEO of Masimo, at a roundtable of the CEOs of top Bangalore hospitals.

Joe Kiani, Founder and CEO, Masimo, commented, "The Indian healthcare sector recognizes the need for technologies that help their clinicians get the best results, the first time. Masimo's noninvasive patient monitoring technology innovations offer capabilities that have never been possible before. With a large population and a burgeoning demand for an improved quality of life – including the safe, high-quality healthcare to which all are entitled – India continues to be a focus market for Masimo. We will continue to invest in India and strive to make our technologies and products as accessible as possible, as evidenced by the new Rad-97 and Next Generation SedLine."

Bharat Monteiro, Masimo Country Manager for India, noted, "Masimo is committed to doing what is best for patient care in India. In the course of our engagement with leading Indian hospitals, we have witnessed an increased awareness of and commitment to patient safety requirements. Medical providers across the country are eager to adopt advanced technologies and monitoring devices, such as Rad-97 and Next Generation SedLine, which we hope will help provide access to better healthcare, at lower cost."

Dr. Ashutosh Raghuvanshi, Managing Director and Group CEO of Narayana Health Hospitals, one of the participants in the roundtable, commented, "We constantly endeavor to improve the facilities at our hospitals to ensure better patient care and treatment outcomes. With the newly launched Rad-97, we will be able to use Masimo SET® pulse oximetry in more care areas, including ward monitoring, which will help facilitate better monitoring and patient treatment. Narayana Health performs the highest number of cardiac surgeries in India, and I believe that noninvasive hemoglobin (SpHb) will add immense value to complex cardiac surgeries, helping us reduce unwarranted transfusions and the risk of infection."

Rad-97 features Measure-through Motion and Low Perfusion SET® pulse oximetry, which studies have shown helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Rad-97 also offers the same upgradeable rainbow SET technology as the Radical-7® Pulse CO-Oximeter, in a versatile, standalone monitor configuration. Using Rad-97, clinicians can monitor such rainbow® measurements as total hemoglobin (SpHb®) and PVi®. Studies with SpHb have shown reductions in unnecessary blood transfusion+,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 rainbow® can also measure methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), Oxygen Reserve Index* (ORi), and oxygen content (SpOC). Rad-97 also features an integrated camera* for clinician tele-presence via Patient SafetyNet™++ and a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs.

SedLine features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, as well as a Density Spectral Array (DSA), an easy-to-interpret, high-resolution display of bi-hemispheric activity. Next Generation SedLine enhances Masimo's processed EEG parameter, the Patient State Index (PSI), to make it less susceptible to electromyographic (EMG) interference and to improve performance in low-power EEG cases.

@MasimoInnovates || #Masimo

*Rad-97, the camera feature, Next Generation SedLine, and ORi do not have 510(k) clearance and are not available in the U.S.
+Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
++The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-97™ Pulse CO-Oximeter® and Next Generation SedLine® Brain Function Monitoring. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97 and Next Generation SedLine, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Ajith Pai / Amrutha Moorthy
Adfactors PR (Masimo in India)
Phone: +91 96633 94732
Email: ajit.pai@adfactorspr.com / amrutha.moorthy@adfactorspr.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for TFA-1 Single-Patient-Use Forehead Sensor

Irvine, California – December 19, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for the TFA-1 Single-Patient-Use Adhesive Forehead Sensor. This single-patient-use sensor allows clinicians to monitor patients using Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry from an alternative monitoring site, the forehead, rather than a finger.

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Forehead sensors may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes, and were shown in a 2004 study to have faster detection of desaturation and resaturation, as compared to digit sensors.1 Forehead sensors can also be easily accessed during surgery and resuscitation and on patients with finger deformities or whose fingers are not accessible. As a single-patient-use sensor, TFA-1 avoids the management complexities (cleaning, storage, and inter-department transport) that accompany reusable sensors.

Masimo SET® includes measurement of oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and PVI®, a measure of the dynamic changes in PI that occur during the respiratory cycle. Masimo SET® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Masimo SET® helps clinicians monitor more than 100 million patients a year2 and is used by 8 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.3

@MasimoInnovates || #Masimo

References
1. Redford DT et al. Intraoperative Perfusion Changes at Two Pulse Oximetry Monitoring Sites: The Digit vs. the Nare. Anesth Analg. 2004;98(2S)S-94.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo TFA-1 Sensors and SET® pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo TFA-1 Sensors and SET® pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Giving Back with Masimo

Irvine, California – December 6, 2016 – Masimo (NASDAQ: MASI) gives thanks, as always, for the many joys and successes that 2016 has brought us. It has nonetheless been a difficult year, both at home and abroad: millions of refugees, displaced from war-torn homelands, continue to suffer. In low-resource settings across the world, many of the most at-risk patients lack access to even the most basic medical care, such as oxygen. Brexit and a particularly contentious presidential election have left many people feeling more divided than united. And hospital patients around the world, even those lucky enough to have good medical care, continue to experience unnecessary harm and to die as a result of inadvertent mistakes and lapses in patient safety.

As in years past, in the spirit of giving back and of trying to make the world a better place for everyone, we humbly ask you, our loyal friends and customers, to help us to donate to some of what we believe to be the worthiest charities, representing a variety of causes. We simply ask that you send an email to charity@masimo.com, specifying your choice from the list below, and we will donate $10 in your name to that charity. We also encourage you to donate to them directly.

As part of Masimo's commitment to giving back, in 2016 we have continued to focus on providing relief to refugees through donations to Doctors Without Borders, the Syrian Community Network, and the Syrian American Medical Society. Employee donations, matched by the Kiani family, have to date raised more than $200,000. Last year, we announced a $5 million medical equipment donation to Jordan, to help provide healthcare to over 1 million Syrian refugees, and work on that project has continued throughout 2016. In addition, this year we've formed several partnerships dedicated to advancing the quality of healthcare in low-resource settings around the world: with Smile Train, to promote safe cleft-lip and palate surgery; with a variety of non-profit organizations to create United for Oxygen, an alliance dedicated to increasing access to medical oxygen and pulse oximetry; and the Gates Foundation, to develop a low-cost pulse oximeter and promote pneumonia screening.

Joe Kiani, Founder and CEO of Masimo, notes: "Tragic headlines, bespeaking much loss and woe, have dominated the news cycle for many years now. It's time for us all to take steps to transform those headlines, so that rather than the negative, we can focus on the great work so many are doing to care for those in need around the world: helping refugees find safe and dignified refuge amongst us, eliminating preventable hospital deaths, and providing access to safe surgery for the billions who still don't have it. Please join us in trying to channel the energy of despair into forces for good. And thank you for being a part of our Masimo family. We are grateful to you all and wish you all a wonderful holiday season. Here's to a happier and healthier New Year!"

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Receives Gates Foundation Grant to Develop Combined Pneumonia-Screening Device for High-Burden Settings

Irvine, California – November 11, 2016 – Masimo (NASDAQ: MASI) announced today, in advance of World Pneumonia Day tomorrow, that it has received a grant of $4.95 million from the Bill & Melinda Gates Foundation (BMGF). The grant will support Masimo's efforts to develop a low-cost pulse oximeter for use in pneumonia screening in several low-resource areas outside the U.S. While still in development, the device will likely measure oxygen saturation (SpO2) and respiration rate (RR) - two key parameters that would provide additional information to clinicians when screening potential pneumonia cases in high-burden settings. The grant will also support studying the clinical use environment in such settings to ensure that the device is user friendly and fit for its purpose. The grant may also support the education materials to promote proper training and use of the device at all literacy levels.

Pneumonia remains the single largest treatable infectious cause of death in children worldwide, causing over 900,000 deaths each year among children under 5 years of age.1 In a study funded by the BMGF Diagnostics Modelling Consortium, the researchers concluded that in settings where supplemental oxygen is available, the addition of pulse oximetry to standard integrated management of child illness protocols could reduce pneumonia mortality rates.2 More recently, the World Health Organization (WHO) has sponsored an ongoing multi-country study to further assess how to enhance community case management of pneumonia treatment.3

Enhancing patient screening is critically important to reducing the global burden of pneumonia. Moreover, enhanced screening may empower healthcare providers by supporting informed decisions related to pneumonia diagnosis and treatment, with the appropriate administration of antibiotics and oxygen therapy when needed. Masimo and BMGF hope that Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry technology can help better screen children in even the most challenging conditions.

Rasa Izadnegahdar, Senior Program Officer on the Pneumonia Team at BMGF, commented, "We are excited to partner with Masimo for the purpose of improving screening for pneumonia to allow improved referral decisions by health workers in low-resource settings. Evaluating a child for fast breathing is the cornerstone of pneumonia assessment and combining this with a reliable and effective approach to assessing oxygen saturation can have significant impact in ensuring children with pneumonia receive appropriate care. Our landscape review of pneumonia diagnostic aid technologies has clearly demonstrated the poor performance of existing diagnostic aids, particularly respiratory rate timers. Diagnostic aids with improved sensitivity and specificity that are adapted and designed for use by health workers and caregivers can make a significant impact on pneumonia treatment. We look forward to working with Masimo to adapt their precise and accurate technology to respond to the needs of health workers, caregivers, and children in countries where pneumonia burden and deaths remain unacceptably high."

Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry is used to monitor millions of patients around the world. This project demonstrates the company's strong commitment to reducing the unnecessarily high global burden of pneumonia by bringing its proven patient screening and monitoring technology to the areas of the world that need it most.

"We are gratified to be able to partner with BMGF, which recently joined us in co-founding the United for Oxygen Alliance to increase access to oxygen and pulse oximetry in Ethiopia, in supporting our efforts to help fight pneumonia," said Joe Kiani, Founder and CEO of Masimo. "We hope to bring a much-needed screening tool to areas of the world blighted by countless needless deaths that are due to an illness considered low-risk in the developed world."

@MasimoInnovates || #Masimo

References
1. Pneumonia Fact Sheet, World Health Organization (WHO), September 2016. http://www.who.int/mediacentre/factsheefts/fs331/en/.
2. Floyd J et al. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528(7580):S53-9.
3. World Health Organization (WHO), 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide comparable accuracy and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Philips and Masimo Sign Multi-Year Business Partnership Agreement in Patient Monitoring and Select Therapy Solutions

  • Multi-year business partnership combines Masimo's expertise in non-invasive sensor and signal processing technologies and Philips' expertise in integrated patient monitoring and therapy solutions
  • Business partnership involves technology integration and marketing and sales cooperation in North America and certain markets in Asia and Europe
  • Agreement ends all pending lawsuits between the two companies and, in addition to marketing and integration commitments, includes a cash payment of USD 300 million by Philips to Masimo

Amsterdam, the Netherlands and Irvine, California – November 7, 2016 – Royal Philips (NYSE: PHG; AEX: PHIA) and Masimo Corporation (NASDAQ: MASI) today announced a wide-ranging, multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. The partnership includes joint marketing and sales programs in North America and certain markets in Asia and Europe for Masimo's non-invasive sensor technologies, such as its rainbow® and SET® platforms, in conjunction with Philips' patient monitoring and select therapy solutions. In addition, Philips will in the future integrate Masimo SedLine® brain function monitoring, O3 regional oximetry, and Nomoline capnography technologies in certain Philips IntelliVue® monitors.

Philips is a global leader in patient monitoring solutions with a comprehensive product portfolio ranging from multi-parameter bedside monitors to wearable patient monitors combined with mobile applications and clinical decision support tools. With a primary focus on prediction and prevention of patient deterioration, these integrated solutions aim to support clinical workflow and caregiver efficiencies, and enhance patient care. In 2015, an estimated 275 million patients were monitored using Philips' patient monitoring solutions.

Sensor and signal processing technologies are an essential component of patient monitoring solutions, and Masimo is a prolific innovator in this field. Examples of Masimo's non-invasive sensor and signal processing technology innovations include Masimo SET® pulse oximetry, Masimo rainbow® Pulse CO-Oximetry and Masimo total hemoglobin (SpHb®) monitoring technology.

"This business partnership agreement marks an important day for us and our customers as two leaders in patient monitoring collaborate to develop solutions designed to enhance clinical outcomes and patient safety," said Frans van Houten, CEO of Royal Philips. "I am very satisfied that we have reached an agreement that is beneficial for both companies and that we have ended our legal disputes. Going forward, Philips and Masimo will completely focus on jointly delivering meaningful innovations to our customers, such as the integration of Masimo rainbow® technology across our IntelliVue® patient monitoring product range."

"It's wonderful to think that Masimo and Philips will be working together for the benefit of patients and clinicians around the world," said Joe Kiani, Chairman and CEO of Masimo. "I am delighted that we were able to reach this important agreement which allows us to focus on the future to deliver the solutions that our customers have been looking for."

In conjunction with the appropriate Philips patient monitoring platform, Masimo's rainbow SET technology analyzes multiple wavelengths of light to accurately measure total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®) and Pleth Variability Index (PVI®) non-invasively and continuously. Continuous monitoring of SpHb on a Philips monitor at the point of care provides clinicians with real-time visibility to changes in hemoglobin in between invasive blood samplings.

Anticipated cash flow and income consequences for Philips
As part of the business partnership agreement, Philips and Masimo have agreed to end all pending lawsuits between the two companies, which includes that Philips is released from paying the USD 467 million (approximately EUR 428 million) jury verdict that was awarded to Masimo in October, 2014. Philips has agreed to make a USD 300 million cash payment (approximately EUR 275 million) to Masimo in the fourth quarter of 2016; and to invest in the relationship by making certain marketing and product integration commitments over the coming years. Entering into the business partnership agreement has minimal impact on income from operations (EBIT) in the fourth quarter of 2016.

Anticipated cash flow and income consequences for Masimo
As the result of anticipated legal fee savings during the fourth fiscal quarter, Masimo now expects its fiscal 2016 GAAP earnings per diluted share, exclusive of the impact of the business partnership agreement, to be $2.14, up from $2.13. Masimo expects to use some of the after-tax proceeds from the business partnership agreement to repay amounts outstanding under its revolving line of credit. The guidance set forth above is an estimate only and actual performance could differ.

@MasimoInnovates || #Masimo

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips' health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 70,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements - Royal Philips
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

Forward-Looking Statements - Masimo
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

For further information, please contact:

Eli Kammerman
Masimo Investor Relations
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Evan Lamb
Masimo Media Contact
Phone: (949) 396-3376
Email: elamb@masimo.com

Steve Klink
Philips Groups Communications
Phone: +31 6 10888824
Email: steve.klink@philips.com

Vanessa Bruinsma-Kleijkers
Philips Investor Relations
Phone: +31 20 5977447
Email: Vanessa.Bruinsma-Kleijkers@philips.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Investigates the Impact of Masimo Continuous SpHb® and PVI® on Anesthesia-related Mortality

Chicago, IL – October 22, 2016 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the American Society of Anesthesiologists' (ASA) Annual Meeting in Chicago. In the study, researchers at Hopital Dupuytren, part of the Centre Hospitalier Universitaire of Limoges, France (CHU Limoges), investigated the clinical utility of noninvasive, continuous hemoglobin (SpHb®) and PVI® (a measure of the dynamic changes in perfusion index that occur during the respiratory cycle), two Masimo rainbow SET measurements. The researchers' goal was to determine, at the scale of a whole hospital, improvement in mortality and transfusion needs.1

In the prospective, single-center, observational study, Professor Nathalie Nathan and colleagues reviewed two sets of patients over two eleven-month periods, before (2013) and after (2014) implementation of a clinical algorithm to guide transfusion and fluid administration. Anesthesiologists, nurses, and residents were trained on the implementation of the clinical algorithm. Masimo Radical-7® Pulse CO-Oximeters® were installed in all operating rooms, recovery rooms, and intensive care units. The Radical-7s were connected to Masimo Patient SafetyNet™* for trend data collection. All surgical patients presenting to the hospital were accepted, with these exceptions: EMT, ophthalmology, odontology, radiology, neurosurgery, and patients less than 18 years of age.

The study included 18,867 patients (in the two groups), of whom 3450 underwent SpHb and PVI monitoring via Radical-7. The patients in the monitoring group received vascular filling with crystalloids or blood, according to the clinical algorithm. Demographic, anesthesia, surgical, and transfusion data were collected in electronic medical records. The researchers compared the percentage of patients in the monitored group who received transfusions within the first postoperative 48 hours to the percentage in the non-monitored group. They also compared mortality rates for each group at 30 days and 90 days following surgery.

Using the cox-proportional hazard model, the researchers found that the patients in the group monitored with SpHb and PVI had a 30% reduction in mortality at 30 days and a 25% reduction in mortality at 90 days. The proportion of patients receiving transfusions did not change significantly between the two groups (7.9% in 2013, 8.5% in 2014, p = 0.1323), nor did the number of blood units transfused within 48 hours (3.4 ± 2.7 in 2013, 3.4 ± 2.0 in 2014, p > 0.05). However, in non-cardiac surgery, patients were transfused sooner in the operative or recovery room (72.9% vs 56.1%, p = 0.0002).

The researchers concluded that "Monitoring SpHb and PVI integrated in a vascular filling algorithm allowed earlier transfusion and reduces mortality at a scale of a whole hospital with different clinical practices (and practitioners) and unselected patients."

"Access to continuous monitoring of Hb levels and fluid responsiveness has changed the way we address blood and fluid management. By lowering inadequate fluid filling at the beginning of anesthesia, we are able to avoid diluting patients inadequately and this data helps us to guide precisely the amount of fluids or blood that must be given to patients on a case by case basis," stated Professor Nathan, Head of the Department of Anesthesiology at CHU Limoges. "Patients are transfused earlier when needed and hypovolemia is precisely treated with crystalloid. These two facts may explain the decrease in mortality at one and three months that we observed in this study. We strongly believe that surgeries of intermediate severity such as hip or knee replacement procedures as well as severe surgery will benefit from this technology. Because it is easy to use, quick to administer, provides continuous data, and does not harm the patient in any way, it is more applicable to common clinical practice."

Joe Kiani, Founder and CEO of Masimo, commented, "We have created technologies that have been shown to save babies' eyesight2, screen for CCHD in newborns3, and reliably monitor patients in post-surgical wards4,5,6, but this is the first time a study has shown that one of our technologies has such a big impact on mortality. Needless to say, we are excited and thank Dr. Nathan for her and her colleagues' research. We look forward to more studies like this that investigate the impact of SpHb and PVI on other patients at other hospitals, and hope to see similar results."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb monitoring, accompanied by laboratory diagnostic testing, may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions** and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.7,8

@MasimoInnovates || #Masimo

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.
**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
4. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
5. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
8. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb® and PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb and PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Rad-97 Pulse CO-Oximeter®

Neuchatel, Switzerland – October 6, 2016 – Masimo (NASDAQ: MASI) announced today the CE marking of the Rad-97 Pulse CO-Oximeter®. Rad-97 offers the same Measure-through Motion and Low Perfusion SET® pulse oximetry and upgradeable rainbow SET technology as the Radical-7® Pulse CO-Oximeter – in a versatile standalone monitor configuration.

Masimo Rad-97 Pulse CO-Oximeter, Masimo Rad-97 with Camera, Masimo Patient SafetyNet with SafetyNet Surveillance
top: Masimo Rad-97 Pulse CO-Oximeter®
center: Masimo Rad-97 with Camera
bottom: Masimo Patient SafetyNet with SafetyNet Surveillance

Rad-97 features a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. Rad-97 provides both built-in wireless connectivity, via Wi-Fi and Bluetooth®, and built-in wired options, including Ethernet, USB, and Nurse Call Interface connections. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed.

In select markets outside the United States, Rad-97 will be available with an optional camera, which will be used in conjunction with Masimo Patient SafetyNet™*. The camera includes a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. The system will be able to use the hospital's existing IT network and to provide additional viewing of images in the same care area. Through Rad-97, it will be possible to connect other devices a patient may be using, such as glucometers and scales, to Patient SafetyNet and to remotely allow for interaction between clinicians and patients or other clinicians.

Like Radical-7, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements total hemoglobin (SpHb®), methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), and oxygen content (SpOC). In select markets outside the United States, additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp) are available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

"Rad-97 brings our core SET® and rainbow® technologies to a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes," said Joe Kiani, Founder and CEO of Masimo. "We've engineered Rad-97 to take advantage of the latest advances in adaptability and connectivity, packaging Masimo's industry-leading noninvasive technology in a cost-effective monitor that will make it more accessible and useful to clinicians and patients than ever."

ORi and RRp parameters and the camera feature do not have 510(k) clearance and are not available in the U.S.

@MasimoInnovates || #Masimo

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Rad-97 Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97 Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Honors Birthday of Mahatma Gandhi with Global Holiday

Irvine, California – October 2, 2016 – Masimo (NASDAQ: MASI) announced today that in honor of the birthday of Mahatma Gandhi (October 2, 1869), the company will close worldwide and offer an additional paid holiday to employees on Monday, October 3rd.

Mahatma Gandhi, born Mohandas Karamchand Gandhi, is considered the preeminent leader of the Indian independence movement, famous for seeking change, conflict resolution, and agreement through nonviolent protest, often through public fasting. He is still honored today as a global symbol of peace, with his birthday a national holiday in India and celebrated worldwide as the International Day of Nonviolence.

"Masimo has chosen to honor Gandhi's birthday to remind its employees and partners worldwide of the enduring importance of those role models who have helped shape our world for the better. At Masimo, we strive each day to remain true to our promises and responsibilities," said Joe Kiani, Founder and CEO of Masimo. "For us, that includes being thoughtful citizens of the world, striving to improve patient care through our innovative products and technologies. In these difficult times, when injustice, violence, and hatred are never far from the headlines, it's especially important to remember and admire the life of one who so consistently embodied peace, forgiveness, and understanding. Gandhi got what his people wanted and gained his country's independence from British rule through peaceful civil disobedience. I hope all Masimo employees worldwide will use this extra day to take stock of their lives, their goals, and their responsibilities, and to take steps to create a more just and peaceful world."

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Partners with Smile Train to Advance Safe Surgery

Irvine, California – September 30, 2016 – Masimo (NASDAQ: MASI) announced today that it is partnering with Smile Train to help ensure the safety of patients undergoing cleft lip and/or palate surgery in low-resource settings around the world.

Patient monitoring, including the use of pulse oximetry, is a key part of ensuring safe surgical care; however, in lower-resource settings essential monitoring equipment is often unavailable, particularly in the post-operative period.1 Working together, Smile Train and Masimo are helping to remove this barrier by equipping surgical programs in 15 countries in Asia, Africa, Central America and the Middle East with pulse oximeters.

Smile Train is an international organization that leverages the "teach a man to fish" model to train and empower local medical professionals to provide safe, high-quality, comprehensive cleft treatment for children in their own communities. Through Smile Train's local partnerships in 85+ countries, the organization has provided more than 1,000,000 cleft surgeries to date.

Through this partnership, Masimo is providing over 460 Masimo SET® Measure-through Motion and Low Perfusion pulse oximeters to Smile Train's nurse training programs and partner hospitals to support improved patient monitoring and safety. Additionally, Masimo and Smile Train will work together to develop additional initiatives to ensure that post-operative pulse oximetry can be scaled across all Smile Train programs.

One of the most common birth defects in the world, a cleft lip and/or palate occurs before a child is born, when the lip and/or roof of the mouth fail to fuse together properly during fetal development. In higher-resource settings virtually all babies with clefts have reconstructive surgery as it is relatively simple, inexpensive, and immediately transformative. This is not the case in lower-resource settings, where, as highlighted by the World Federation of Societies of Anaesthesiologists' SAFE-T Campaign, an estimated 70% of the world's population do not have access to safe and affordable anesthesia and surgical care.1,2 This startling gap in surgical access means the estimated 170,000 children born with clefts in lower-resource settings do not receive surgical treatment and live with difficulties eating, breathing, speaking, and, in the longer term, are less likely to enroll in school or hold jobs due to the stigmas associated with physical defects.3

"Proper surgical monitoring, including essential pulse oximetry, is crucially important to ensuring safe surgical outcomes. Smile Train is excited to partner with Masimo to make their high-performing, Signal Extraction Technology pulse oximeters available at Smile Train partner hospitals as we work together to continue providing safe and quality cleft care to children in need all over the world," said Susannah Schaefer, CEO of Smile Train.

"One of the greatest joys is seeing a smile on the face of a child. Every child on earth deserves to have access to safe surgery, to be treated with dignity and love, and to share their beautiful smiles," said Joe Kiani, Founder and CEO of Masimo. "Partnering with Smile Train is a fundamental part of our commitment to the Sustainable Development Goals and to our belief that no matter where a person lives or where they were born, access to quality healthcare that is dignified and safe is a human right, not a privilege. We are very proud of the work that Smile Train has done to improve surgical safety and access for cleft patients in local communities around the world. We value their commitment to scaling the use of quality pulse oximetry to all programs."

Friday, October 7th is World Smile Day®, on which we are reminded to "Do one act of kindness. Help a person smile!"4 The smile is an international symbol of peace, happiness, and kindness that knows no barriers or boundaries. Masimo and Smile Train are proud to be partnering to bring smiles to the faces of children around the globe, not just on World Smile Day®, but on every day of the year. We encourage everyone to participate in World Smile Day® this year!

@MasimoInnovates || #Masimo || @Smiletrain || #WorldSmileDay

References
1. Meara JG et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624.
2. World Federation of Anaesthesiologists (WFSA) Safe Anaesthesia For Everybody – Today "SAFE-T" Campaign, 2016.
http://www.wfsahq.org/get-involved/safe-t.
3. Smile Train Medical Advisory Board.
4. http://www.worldsmileday.com/.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

About Smile Train
Smile Train is an international children's charity with a sustainable approach to a single, solvable problem: cleft lip and palate. Millions of children in developing countries with untreated clefts live in isolation, but more importantly, have difficulty eating, breathing and speaking. Cleft repair surgery is simple, and the transformation is immediate. Our sustainable model provides training, funding, and resources to empower local doctors in 85+ developing countries to provide 100%-free cleft repair surgery and comprehensive cleft care in their own communities. To learn more, please visit smiletrain.org.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Shari Mason
Smile Train
Phone: (212) 689-9199
Email: smason@smiletrain.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Foundation Co-Founds United for Oxygen Alliance

Groundbreaking Public-Private Partnership to Increase Access to Oxygen and Pulse Oximetry Launched at Clinton Global Initiative

Irvine, California – September 24, 2016 – Masimo (NASDAQ: MASI) announced today that the Masimo Foundation has co-founded the United for Oxygen Alliance, as part of a Clinton Global Initiative (CGI) commitment. The first-of-its-kind public-private partnership, announced this week at the final CGI Annual Meeting, will seek to expand access to medical oxygen and pulse oximetry for women and children in Ethiopia. Other partners in the Alliance, which has fifteen members in total, include the Bill & Melinda Gates Foundation (BMGF), the United Nations, PATH, Philips, the Pneumonia Innovations Team, Save the Children, UNICEF, and USAID.

Lack of medical oxygen access contributes to the deaths of more than 120,000 young children and thousands of pregnant women, globally, each year. It is estimated that in Ethiopia alone, each year 11,000 women die in pregnancy or during childbirth, 60,000 babies die in their first month, and 30,000 children die from pneumonia.1,2 Many of these deaths could be prevented by better access to medical oxygen and reliable pulse oximetry technology.3 An oxygen access agenda is central to that of the Ethiopian government, which has made it a part of their 2015-2020 Health Sector Transformation Plan and National Newborn and Child Survival Strategy.

United for Oxygen will partner with the Ethiopian government to increase availability of pulse oximetry screenings and oxygen therapy technologies across the country. In addition, it will provide training for local staff; establish sustainable financial solutions for procuring, installing, and maintaining equipment; and promote oxygen access and technologies in the policies and guidelines of Ethiopian health authorities. After the pilot program, the Alliance hopes to roll out similar medical oxygen and pulse oximetry programs in other countries where women and children are particularly at risk.

Leith Greenslade, Co-Chair of the Pneumonia Innovations Team, commented, "United for Oxygen is the first time companies and development agencies have joined forces to support a government to increase access to pulse oximetry and oxygen therapy across an entire African nation – in this case Ethiopia. My hope is that we will demonstrate that not only can pulse oximetry and oxygen prevent many more Ethiopian children from dying of pneumonia, but that health systems that routinely provide pulse oximetry screening and oxygen will be much more effective at driving down death rates from childbirth, unsafe surgery, cardiac arrest and injury."

Masimo, as a global leader in noninvasive monitoring technologies and whose SET® Measure-through Motion and Low Perfusion pulse oximetry technology is estimated to be used on more than 100 million patients around the world, will be responsible for improving the availability of pulse oximetry in hospitals and health centers, particularly in maternity and pediatric units. Masimo's role in United for Oxygen will also include developing an efficient, effective health screening model to prevent, detect, and treat pneumonia, as well as collaborating on recommendations for sustaining the program post-deployment through training, education, and maintenance.

Rasa Izadnegahdar, Senior Program Officer on the Pneumonia Team, BMGF, noted, "Masimo is uniquely positioned to provide leadership in the introduction of innovative life-saving devices in partnership with countries as recently exemplified by the Oxygen Roadmap of the Ethiopia Federal Ministry of Health."

"This cannot be overstated: regardless of where you live or were born, you deserve access to quality healthcare – including the life-saving benefits of reliable pulse oximetry and oxygen therapy," said Joe Kiani, Founder and CEO of Masimo. "Masimo continues to champion systematically safe, dignified health care for all, and we are proud for the Masimo Foundation to be one of the founding members of United for Oxygen. We look forward to collaborating further on this important project."

@MasimoInnovates || #Masimo || @0X2020 || #United4Oxygen || #CGI2016 || #UNGA || #globalgoals

References
1. Kuti BP et al. Determinants of oxygen therapy in childhood pneumonia in a resource-constrained region. ISRN Pediatr. 2013 Jun 2;2013:435976.
2. Rudan I, et al. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. 2008 May; 86(5): 408–416.
3. Floyd, et al. Evaluating the Impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 528, S53-S59 (3 December 2015).

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study on Abdominal Surgical Patients Investigates Clinical Utility of Masimo PVI®

Irvine, California – September 15, 2016 – Masimo (NASDAQ: MASI) announced today the findings of a study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong. In the study, researchers at Cairo University in Egypt investigated the clinical utility of a Masimo SET® noninvasive, continuous measurement, PVI®.

In the prospective study of 60 adult patients undergoing major abdominal surgery, Drs. Hafez and Helmy of Cairo University evaluated the performance of Masimo PVI as a non-invasive guide to fluid optimization, as compared to Transesophageal Doppler. Patients were divided into fluid responders and non-responders, based upon the change in stroke volume due to a bolus response. The baseline value of PVI was significantly higher (p < 0.05) in responders compared to non-responders. The authors also noted that a baseline PVI cutoff value of 11 had 96.67% sensitivity and 33.33% specificity for predicting greater than 10% stroke volume increase. They concluded that PVI is "an efficient predictor of fluid responsiveness...in patients undergoing elective major abdominal surgery."1

PVI is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In clinical studies, PVI has been shown to help clinicians assess fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVI as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9

@MasimoInnovates || #Masimo

References
1. Hafez, Helmy. Evaluation of Plethysmographic variation indices for assessing fluid responsiveness in major operations using Masimo Radical-7 Pulse CO-Oximeter. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR371.
2. Cannesson M. et al. Br J Anaesth. 2008;101(2):200-6.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q., Mi W.D., Zhang H. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T. et al. Crit Care Med. 2011;39(2):294-299.
7. Byon H et al. BJA. 2012 December; DOI 10.1093/bja/aes467.
8. Feissel M et al. J Crit Care. 2013 May 14
9. Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Finds Continuous, Noninvasive Hemoglobin Monitoring Using Masimo SpHb® May Reduce Intraoperative Red Blood Cell Transfusion

Irvine, California – September 9, 2016 – Masimo (NASDAQ: MASI) announced today announced today that in a new study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong, researchers concluded that continuous and noninvasive hemoglobin monitoring, using Masimo SpHb®, may reduce excessive intraoperative red blood cell (RBC) transfusion.1

In a retrospective review of 371 patients who underwent intraoperative RBC transfusions between 2012 and 2014 at Fukushima Medical University in Japan, Dr. Imaizumi and colleagues compared 94 patients who had noninvasive hemoglobin measurements to 277 patients who did not (the control group). The total transfusion volumes and transfusion volume per 1 g of blood loss were determined for each group.

Comparing the groups, researchers noted that "a significantly lower mean RBC transfusion volume per 1 g of blood loss was observed in the SpHb group compared with the [control] group (SpHb group, 0.9 ± 1.0 ml/g blood loss vs [control] group, 2.4 ± 5.9 ml/g blood loss, p < 0.01)." They also observed that there was "no significant difference...in the average RBC transfusion volume (SpHb group, 815 ± 819 ml vs. [control] group, 785 ± 773 ml, p=0.75), or the preoperative hemoglobin concentration (SpHb group, 10.4 ± 1.9 g/dL vs. [control] group, 10.2 ± 2.4 g/dL, p=0.27) between the groups." According to results from this abstract, the authors concluded that "SpHb measurements are associated with reducing excessive intraoperative RBC transfusion."

"This is the third study, published by different researchers on three continents (US2, Egypt3, and now Japan1) that has shown that in addition to other clinical tools, SpHb may be used to help clinicians make informed transfusion decisions during different types of surgery*," stated Dr. Steven Barker, Ph.D., M.D., Chief Science Officer, Masimo.

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb with laboratory diagnostic test may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.2,3

Last week Masimo announced that in response to the Zika virus and its potential impact on the availability of blood products, Masimo has created a special program to dramatically reduce the cost of and increase access to Masimo's SpHb solutions, as SpHb has been shown to help clinicians reduce blood transfusions in both low and high blood loss surgery. This special program will be available wherever the blood supply is affected by the Zika virus.

@MasimoInnovates || #Masimo

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
2. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9.
3. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®and the availability of Masimo's special program for SpHb solutions. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo MightySat is Available at Apple.com and Select Apple Retail Stores in the US and Canada

Apple Health App Integrates MightySat Data

Irvine, California – September 6, 2016 – Masimo (NASDAQ: MASI) announced today that MightySat, a fingertip pulse oximeter designed for general wellness and health applications including sports, fitness, and relaxation management, is now available at Apple.com and select Apple retail stores in the US and Canada.

Masimo MightySat and Personal Health App
Masimo MightySat™ and Personal Health App

Masimo pulse oximeters, the leading brand in hospitals, provide accurate measurements when other pulse oximeters fail. By using a revolutionary invention called Signal Extraction Technology® (SET®), which allows oxygen saturation and pulse rate to be measured through challenging conditions including movement and low blood flow, the same high performance Masimo SET® technology used in hospitals is now available to Apple customers with MightySat.

The MightySat provides the following noninvasive measurements:

  • Oxygen Saturation (SpO2)
  • Pulse Rate (PR)
  • Perfusion Index (PI)

Masimo SET Accuracy Compared to That of 19 Other Hospital-Grade Pulse Oximeters
Masimo SET® Accuracy Compared to That of 19 Other Hospital-Grade Pulse Oximeters

In a study of 70 healthy volunteers during conditions of movement and low blood flow, Masimo SET® was the most accurate pulse oximeter when compared to 19 other hospital-grade pulse oximeters.1 SpO2 accuracy was defined as being within 7% of the reference value and pulse rate accuracy as being within 10%. Masimo SET® SpO2 was accurate 94% of the time while on average, the 19 other hospital-grade pulse oximeters were accurate only 60% of the time, with the least accurate only displaying accurate SpO2 27% of the time. Masimo SET® pulse rate was accurate 85% of the time while on average, the 19 other hospital-grade pulse oximeters were accurate only 27% of the time, with the least accurate only displaying accurate pulse rate 5% of the time.

Leading athletes and sports teams are increasingly using MightySat. "The reliable measurements of oxygen saturation and pulse rate from Masimo pulse oximeters were an important part of my training and recovery regimen to achieve peak athletic performance," said Dotsie Bausch, 2012 Olympic medalist in cycling. "I trust MightySat to accurately track and trend my data on a daily basis and help me achieve optimal health, wellness, and fitness."

MightySat users can display and track their data on a compatible iOS® device via the free Masimo Personal Health app available in the App Store. With user permission MightySat securely stores and trends measurements displayed in the Masimo Personal Health app in Apple's Health app. With the most recent update, the Masimo Personal Health app also now features same-screen trending for all MightySat measurements.

@MasimoPersonalHealth || #MightySat

The MightySat fingertip pulse oximeter is intended for general wellness and health applications. For medical applications, Masimo offers the MightySat Rx, which is available to medical professionals.

Reference
1. Barker S.J. Anesth Analg. 2002 Oct;95(4):967-72.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo MightySat. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our expectations regarding how retail customers will react to and benefit from the Masimo MightySat; risks related to our assumptions regarding the repeatability of study results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo MightySat, contribute to positive outcomes; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Amendment to Nellcor Royalty Agreement

Irvine, California – September 2, 2016 – Masimo (NASDAQ: MASI) today announced an amendment to the existing settlement agreement initially reached between Masimo and Nellcor in January 2006. Under the terms of the amendment, Medtronic will continue to pay Masimo a royalty of 7.75% for its current pulse oximetry products sold in the United States through October 6, 2018, after which no further royalties will be due under the agreement. For more information, please see the related Form 8-K filed with the Securities and Exchange Commission on September 2, 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Investor Contact:
Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:
Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces a Special Worldwide Program for Total Hemoglobin (SpHb®) Monitoring for Areas Affected by the Zika Virus

Irvine, California – August 29, 2016 – Masimo (NASDAQ: MASI) announced today that in response to the Zika virus and its potential impact on the availability of blood products, Masimo is creating a special program to dramatically reduce the cost of and increase access to Masimo's continuous hemoglobin monitoring (SpHb®) solutions, shown to help clinicians reduce blood transfusions in both low and high blood loss surgery. This special program will be available wherever the blood supply is affected by the Zika virus.

Masimo's special program will allow clinicians and institutions in areas affected by the Zika virus to obtain a 50% discount off the list price of noninvasive SpHb sensors, and in addition, will make a limited number of loaner SpHb monitoring devices available at no cost during this special program.

Joe Kiani, Founder and CEO of Masimo, stated, "Because of how the Zika virus is transmitted, the FDA has recently recommended that the existing blood supply be tested for the virus, in addition to adding Zika screening for new blood donations. While this additional testing is necessary, it may constrain supplies of usable blood products while also increasing the cost of blood for a period of time. Masimo wants to do its part to help clinicians and healthcare facilities mitigate these issues by dramatically reducing the price of and increasing access to our SpHb monitoring solutions, which permit continuous, real-time visibility to changes in hemoglobin levels to help clinicians facilitate more informed and timely transfusion decisions. Independent, published studies completed by different researchers on three continents (US1, Egypt2, Japan3) have shown that SpHb may help clinicians reduce blood transfusions during different types of surgery*."

"We believe the use of continuous SpHb monitoring can help reduce demand for donated blood and the risk posed by blood donated before the additional testing, which may be infected," Mr. Kiani added. "In addition, Masimo will expand its ongoing efforts to increase awareness of the transfusion reduction benefits of the multidisciplinary pillars of Patient Blood Management, including the importance of pre-operative screening and therapies to safely increase patients' hemoglobin levels before elective surgery4."

@MasimoInnovates || #Masimo

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9.
2. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.
3. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
4. Meybohm P et al. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome. Ann Surg. 2016;264:203-211.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Four-Year Partnership with World Federation of Societies of Anaesthesiologists (WFSA)

Joint Initiative, "Safe Anaesthesia – ASAP," Is to Improve Anesthesia Care in Low Resource Countries

Irvine, California and Hong Kong, China – August 29, 2016 – Masimo (NASDAQ: MASI) announced Sunday at the World Congress of Anaesthesiologists (WCA) in Hong Kong that it has become the first Global Impact Partner of the World Federation of Societies of Anaesthesiologists (WFSA). The four-year partnership, "Safe Anaesthesia – ASAP" (Anesthesia Safety Action Plan) will initially identify one country with poor access to safe anesthesia, and will work toward implementing programs and training designed to improve anesthesia care and safe surgery outcomes.

In 2015, the Lancet Commission on Global Surgery reported that approximately 5 billion people – the majority of the world's population – do not have access to safe, affordable anesthesia and surgical care, and estimated that 16.9 million die annually as a result.1 These deaths are attributable to a lack of infrastructure, essential monitoring equipment, and drugs, as well as a shortage of adequately trained healthcare workers.1

As part of the first phase of the joint project between the WFSA and Masimo, a high burden country will be identified as the ASAP's focus. Key to the project's success will be bringing together all stakeholders, including the government, so that infrastructure gaps can be identified, needs assessed, and the ASAP implemented. Implementation will involve a combination of training courses and other educational materials, distribution of essential drugs, and installation of and training on medical equipment. Training, monitoring, and project assessment will be ongoing throughout the four years, with an emphasis on ensuring that the improvements are sustainable.

Lifebox, an NGO (not-for-profit, non-governmental organization) dedicated to improving safe surgery, will also be assisting with training support. Kristine Stave, Chief Operating Officer of Lifebox, commented, "Lifebox works with colleagues on the frontline of the global surgical safety crisis to support long term improvement in the safety and quality of anesthesia care. We know firsthand the challenges of environment, equipment, education – and we also know the extraordinary capacity for positive change that the best partnerships can bring. We're proud to be a part of this urgent and historic undertaking between the WFSA and Masimo, and to be delivering our shared goal of making anesthesia safer for millions of patients worldwide."

WFSA has been uniting anesthesiologists globally for more than 60 years. With a network of hundreds of thousands of anesthesiologists in more than 150 countries, WFSA is well positioned to deliver programs that facilitate learning, and promote the highest standard of anesthesia care globally. Masimo, whose clinically leading SET® pulse oximetry is used to monitor over 100 million patients across the world, has made a commitment to become a WFSA Global Impact Partner in 2016. Together, WFSA and Masimo created the ASAP action plan, which it is hoped will become a model for high burden countries to improve anesthesia care and safe surgery outcomes.

Dr. David Wilkinson, President of the WFSA, stated, "The WFSA is delighted to announce Masimo as our first Global Impact Partner. We work together to improve patient care and access to safe anesthesia around the world."

Dr Adrian Gelb, Chair of the WFSA's Safety and Quality Committee and Professor of Anaesthesia and Perioperative Care at the UCSF School of Medicine, added, "It is essential that we make safe and affordable anesthesia and surgical care available to every patient in every country. Investment in national anesthesia plans, together with key stakeholders, will ensure that specific country needs are met most appropriately in order to make the biggest impact."

"At Masimo, we believe that regardless of where you live or where you were born, access to quality healthcare that is dignified and safe – including safe, effective anesthesia and surgery – is a human right, not a privilege," said Joe Kiani, Founder and CEO of Masimo. "We are delighted to be the first partner with the WFSA in bringing much-needed help, with Safe Anaesthesia – ASAP, to areas of the world blighted by needless deaths."

Mr. Kiani added: "The new millennium goal is no longer to provide all of our people access to health care, but to provide all of our people access to health care that is systematically safe and dignified."

@MasimoInnovates || #Masimo || @0X2020 || @wfsaorg || #WCA2016

References
1. Meara JG, Leather AJ, Hagander L et al. Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Surgery. 2015 Jul;158(1):3-6.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential success of the ASAP. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate

Neuchatel, Switzerland – August 18, 2016 – Masimo (NASDAQ: MASI) announced today the CE Marking of RAS-45, a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM) of respiration rate (RRa®).

Masimo Root<sup>®</sup> with rainbow Acoustic Monitoring<sup>®</sup> (RAM™) of Respiration Rate (RRa<sup>®</sup>) with RAS-45 Sensor

Masimo Root® with rainbow Acoustic Monitoring® (RAM™) of Respiration Rate (RRa®) with RAS-45 Sensor

Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring for all patients receiving opioid-based pain medications.1,2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo's RAS-125c and now RAS-45, that is applied to the patient's neck. Using acoustic signal processing that leverages Masimo's breakthrough Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa). RRa has been shown to be accurate, easy-to-use, and reliable, and to enhance patient compliance.3,4 RRa may facilitate earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients and for procedures requiring conscious sedation.4

Masimo RAS-45 Sensor

Masimo RAS-45 Sensor

RAS-45 is designed to facilitate placement on and improve attachment to the neck, but with a smaller adhesive profile than the RAS-125c. It is flexible and uses a transparent adhesive. Like the RAS-125c, it operates with Masimo MX technology boards to measure RRa and display the acoustic respiration wave form. RAS-45 maintains the same performance parameters, range, and accuracy specifications as RAS-125c. Both sensors are for patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, "RAM harnesses the power of our breakthrough signal processing technology, using Masimo SET® and rainbow® technologies, and applies those achievements to a respiratory measurement derived from the sound of breathing. Studies have found that RAM RRa is more sensitive to detecting respiratory pause5 and yet easier for clinicians and patients to use."3

@MasimoInnovates || #Masimo

References
1 Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.
2 The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. www.jointcomission.org.
3 Macknet MR et al. Anesthesiology. 2007;107:A84 (abstract).
4 Goudra BG et al. Open J Anesthesiol. 2013;3:74-79.
5 Ramsay MAE et al. Anesthesia-analgesia. 2013:117:1.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo RAM, RRa®, and RAS-45. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo RAM, RRa, and RAS-45, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Article Showcases an Effective Surveillance System for General Care Units Using Masimo Patient SafetyNet

Irvine, California – August 15, 2016 – Masimo (NASDAQ: MASI) announced today that a new article published in The Joint Commission Journal on Quality and Patient Safety reports on the results of an expansion of the use of Masimo Patient SafetyNet™* to more than 200 general floor beds at Dartmouth-Hitchcock Medical Center (D-H) in Lebanon, New Hamphire.1 Patient SafetyNet is a remote monitoring and clinician notification system that works in conjunction with a variety of bedside monitors, such as Masimo Root® with Radical-7® and Root with Radius-7®, powered by Masimo SET® pulse oximetry – the first Measure-through Motion and Low Perfusion pulse oximetry and the most accurate and reliable pulse oximeter in such conditions according to over 50 studies.2

Masimo Patient SafetyNet was first implemented in the 36-bed orthopedic unit at D-H in December 2007, as part of a surveillance strategy supporting patient safety improvement. Clinicians reported that after 11 months, rescue events had been reduced by 65% and intensive care unit transfers by 48%, and calculated annual cost savings of $1,480,000.3,4 They also announced that they had experienced zero preventable deaths or instances of irreversible seizure brain damage due to opioids since installation.4 As a result of the positive outcomes of the pilot unit implementation, D-H expanded this continuous patient monitoring approach, including the use of Patient SafetyNet, to remaining post-surgical ward units in February 2009, to medicine ward units in April 2010, and to the pediatric ward unit in February 2012. Patients in more than 200 beds are now covered by D-H's patient surveillance system. As the authors note, "The original success in terms of patient outcomes and enthusiastic endorsement by nurses prompted request from other units for the system and led to the rapid spread of the system across the institution." The improvements first seen in the pilot unit – in addition to the dramatic reductions in rescue events and unplanned transfers, approximately two alarms per patient per 12-hour nursing shift, and resolution of more than 85% of all alarm conditions within 30 seconds and more than 99% before escalation was triggered – have been "sustained over time in spite of increasing patient acuity (up 20% from 2010 to 2015) and unit occupancy (93% in 2015)."

Much of the initiative's success is due to D-H's development of a robust general care alarm management strategy, including the implementation of Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry. As the authors note, "device-level characteristics such as measurement reliability and alarm annunciation" are critical. A systematic approach to alarm management is needed because of the growing problem of "'alarm fatigue' – the growing desensitization of health care providers to alarms" as a result of the "growing number of monitoring devices, combined with suboptimal patient monitoring and alarm management strategies." False and/or nonactionable alarms may occur as much as 90% of the time, according to one study5; another, involving the Philips HP Merlin M1094 monitor, found that 77% were either not recognized or ignored6; a third, involving Nellcor pulse oximetry, found an actual risk for patients in only 3% of alarm states, and that anesthesiologists have been shown to disable alarms because of high false alarm rates.7

D-H attempted to optimize several key elements of an effective alarm management strategy: 1) static alarm settings – setting thresholds based on patient groups to reduce nuisance alarms; 2) alarm delays – introducing a delay of 15 seconds before an alarm sounds, as "Many changes in physiologic parameters are brief and self-correcting"; 3) alarm threshold adjustments – adapting to "physiologic variation among different patients" by adjusting alarms based on a three-tiered system of the static defaults, independent nurse adjustments, and provider-ordered individualized settings; and 4) alarm announcement – having the alarm sent to the nurse in charge of the patient via remote pager and allowing customization of when and how alarms are escalated to additional clinicians, by which practice alarm exposure has now been reduced by almost 90%.

Important to the success of the D-H alarm management strategy was the selection of Masimo SET® and Patient SafetyNet architecture, as part of D-H's patient surveillance system. As the authors note, a fundamental factor affecting operation of and response to clinical monitor alarms is "device-level characteristics such as measurement reliability and alarm annunciation." As the initiative's centrally-monitored parameter they notably chose oxygen saturation (SpO2), measured using Masimo SET® pulse oximetry, which has been shown to reduce false alarms by over 95% and increase true alarm detection to over 97%, even during motion and low perfusion.8 Regarding the choice of remote monitoring system, the authors note that "A previously installed multiparameter monitoring system on the pediatric unit was largely rejected by the staff because of alarm system issues, such as high false alarm rates, lack of directed notification, and ambiguous alarm indicators. The alarm rate [with Masimo Patient SafetyNet] was 75% lower than the alarm rate of the previous system immediately following implementation of [Masimo Patient SafetyNet], and 100% of nursing staff survey respondents were in favor of continuing use of [Masimo Patient SafetyNet]. The staff credited the robust alarm management strategy and leadership rounding with the improved system performance and high level of staff adoption."

"Dartmouth-Hitchcock provides a compelling example of the benefits that a robust patient monitoring and surveillance system, coupled with a carefully executed strategy, can reap," said Joe Kiani, Founder and CEO of Masimo. "It is estimated that as many as 50,000 patients die each year due to failure to rescue patients in the general ward.9 Any hospital that wants to eliminate general ward preventable deaths should read both this article and Dartmouth-Hitchcock's original study, 'Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: A before-and-after concurrence study,' published in 2010.3 Together, they provide an excellent guide to designing, implementing, and maintaining a successful hospital-wide continuous monitoring system, as well as showcasing the innovative practices that have arisen out of their focus on alarm management. Dartmouth-Hitchcock's success story, laid out in a well-executed plan and follow on analysis over nearly a ten-year period, sets a powerful precedent for other medical facilities: it's time for all hospitals to develop hospital-wide alarm management strategies and as part of that, to implement Patient SafetyNet – to help save money and save lives."

@MasimoInnovates || #Masimo

References
1. McGrath, S.P., Taenzer, A.H., Karon, N, Blike, G. "Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation." The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
2. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
3. Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
4. Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.
5. Imhoff M, Kuhls S. Alarm algorithms in critical care monitoring. Anesth Analg. 2006;102:1525-1537.
6. Gorges M, et al. Improving alarm performance in the medical intensive care unit using delays and clinical context. Anesth Analg. 2009;108:1546-1552.
7. Kestin IG, Miller BR, Lockhart CH. Auditory alarms during anesthesia monitoring. Anesthesiology. 1988;69:106-109.
8. Shah N et al. J Clin Anesth 2012 Aug;24(5):385-91.
9. HealthGrades Quality Study. Patient Safety in American Hospitals (July 2004).

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking for Pediatric O3 Regional Oximetry

Neuchatel, Switzerland – August 4, 2016 – Masimo (NASDAQ: MASI) announced today the CE marking for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.

Masimo Root<sup>®</sup> with O3™ Regional Oximetry with Pediatric Sensor
Masimo Root® with O3™ Regional Oximetry with Pediatric Sensor

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain and vital organs are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1 With the release of the O3 pediatric sensor, O3 regional oximetry monitoring of rSO2 is now available to pediatric patients weighing less than 40 kg (88 lbs).

"O3 regional oximetry provides access to valuable data about cerebral oxygen saturation, and studies have shown that the risks of cerebral desaturations include neurological injury2,3, increased length of hospital stays3, increased time on mechanical ventilation4, and other adverse outcomes5," said Joe Kiani, Founder and CEO of Masimo. "With adult trend accuracy of 3% and absolute accuracy of 4% without controlling CO2, and trend accuracy of 3% in pediatric patients6, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatric ones."

Masimo O3 regional oximetry and SedLine® brain function monitoring are both available on a single platform, Masimo Root® – opening up a path to better understanding of the brain.

O3 regional oximetry for use with adults weighing 40 kg (88 lbs) or greater has received FDA 510(k) clearance. O3 regional oximetry for use with pediatric patients weighing less than 40 kg (88 lbs) has not received FDA 510(k) clearance; the O3 pediatric sensor is not currently for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Booth, Dukatz, Ausman, and Wider. "Cerebral and somatic venous oximetry in adults and infants." Surg. Neurol Int. 2010; 1: 75.
2. Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2015 Mar;47(3):447-54.
3. Slater JP, Guarino T, Stack J, et al. Cerebral Oxygen Desaturation Predicts Cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009;87:36-45.
4. Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. The heart surgery forum. 2004;7(5):E376-381.
5. Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. Journal of cardiothoracic and vascular anesthesia. 2013;27(6):1260-1266.
6. Masimo data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3 Regional Oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 Regional Oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Leading Ohio Critical Access Hospital Adopts Masimo Root® with Radius-7® , Radical-7® , and Patient SafetyNet to Create Hospital-Wide Wireless Monitoring and Clinician Notification System

Geneva, Ohio and Irvine, California – July 28, 2016 – Masimo (NASDAQ: MASI) announced today that University Hospitals Geneva Medical Center (UH Geneva), a Critical Access Hospital in Geneva, Ohio, is building a hospital-wide wireless monitoring and clinician notification system using Masimo Patient SafetyNet™* in conjunction with Masimo Root® with Radius-7® and Masimo Radical-7®. UH Geneva is part of University Hospitals, based in Cleveland, Ohio.

Masimo Patient SafetyNet is a supplemental system that enables information from bedside and tetherless wearable monitors to be accessible from remote locations and relays alarm notifications to clinicians. Used with Root, Patient SafetyNet allows hospitals to automate the transfer of patient vital signs, including temperature and blood pressure, to patients' medical records, which may help improve nursing workflows. Root, available with Radical-7 or Radius-7, provides monitoring of Masimo rainbow SET parameters such as oxygen saturation (SpO2) and total hemoglobin (SpHb), and is expandable to monitor additional parameters, such as respiration rate from RAM (rainbow® acoustic monitoring). Radius-7 provides continuous tetherless wearable monitoring of FDA-cleared rainbow SET parameters so that patients can have freedom of movement while being monitored – and studies have shown that patient mobility is a key factor in more rapid patient recovery.1,2 Monitoring parameters from Radical-7 or Radius-7 are sent to Patient SafetyNet through Root, allowing for hospital-wide remote monitoring and clinician notification.

UH Geneva is part of the University Hospitals system, which employs over 26,000 physicians and employees in Northeast Ohio, and whose flagship academic medical center, UH Case Medical Center, is the primary affiliate of Case Western Reserve University School of Medicine. UH Geneva has been using Masimo SET® pulse oximetry for several years. Along with implementing such parameters as RAM acoustic respiration rate, they are now adopting Root with Radius-7, Radical-7, and Patient SafetyNet to create a hospital-wide wireless monitoring solution, which will include remote caregiver notification.

Thomas P. Knowles, MHA, RRT, RPSGT, Manager of Respiratory Therapy and the Center for Advanced Sleep Medicine at UH Geneva, a key stakeholder in implementing the system, commented, "I've always believed in Masimo's technology and felt it was important for us to expand our patient monitoring practices. Patient SafetyNet will provide tremendous benefits."

"Patient safety is extremely important to us," said Dr. Amitabh Goel, Chief Medical Officer at UH Geneva Medical Center. "The addition of Patient SafetyNet, which will work hand-in-hand with Root, Radical-7, and Radius-7, helps ensure our doctors and nurses always have the data they need, when they need it. We're also looking forward to integrating Patient SafetyNet with our EMR system, which will automate many administrative duties and free up our caregivers to focus on the enhanced patient experience we strive for."

"UH Geneva provides a compelling example of the standard of care that more and more community hospitals are adopting," said Joe Kiani, Founder and CEO of Masimo. "Powerful centralized monitoring and surveillance, such as those provided by Patient SafetyNet, fueled by industry-leading rainbow SET and innovative devices like Root with Radius-7, are key to patient monitoring, and it's important, and gratifying, that hospitals like UH Geneva recognize this. We look forward to deepening our collaboration with UH Geneva."

@MasimoInnovates || #Masimo

References
1. Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
2. Ronnenbaum J, Weir J, Hilsabeck T. Earlier mobilization decreases length of stay in the intensive care unit. J Acute Care Phys Ther. 2012;3(2):204-210.

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

About University Hospitals
Founded in May 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and primary care physician offices in 15 counties throughout Northeast Ohio. At the core of our $4 billion health system is University Hospitals Case Medical Center, ranked among America's best hospitals by U.S. News & World Report. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. UH is the second largest employer in Northeast Ohio with 26,000 employees. For more information, go to www.UHhospitals.org.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Radical-7®, Root® with Radius-7®, and Patient SafetyNet. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Radical-7, Root with Radius-7, and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

University Hospitals
Dan Bomeli
Phone: (216) 767-8548
Email: daniel.bomeli@UHhospitals.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates Masimo PVI® as a Predictor of Fluid Responsiveness in Patients Undergoing Liver Transplantation

Irvine, California – July 21, 2016 – Masimo (NASDAQ: MASI) announced today that a new study of patients undergoing liver transplantation evaluated the relationship of PVI® to right ventricular end-diastolic volume (RVEDVI) and concluded that PVI provided a "reliable estimate of [cardiac] preload status and may be a useful predictor of fluid responsiveness."1 PVI measures the dynamic changes in perfusion index that occur during one or more complete respiratory cycles, using the Masimo pulse oximetry plethsymographic waveform.

Because of hemodynamic instability during orthotopic liver transplantation (OLT), estimating cardiac preload to optimize fluid management is essential. There are several methods for estimating cardiac preload. Two conventional static measurements of cardiac filling pressure are pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The standard invasive method is RVEDVI, obtained from thermodilution using a pulmonary artery catheter (PAC).

In the prospective study, published in Transplantation Proceedings and conducted at Chang Gung Memorial Hospital in Taiwan, Dr. H.-C. Lee and colleagues compared methods of estimating cardiac preload, with the aim of evaluating the relationship between a dynamic hemodynamic parameter, PVI (derived from pulse oximetry), and RVEDVI (using a PAC), as well as comparing PVI to the static measures CVP and PAOP. They measured the four hemodynamic parameters–CVP, PAOP, RVEDVI, and PVI–on 18 patients undergoing OLT at 10 defined time points before, during, and at the conclusion of surgery.

Analyzing the 180 measurements from each of the parameters, the Receiver Operating Characteristic (ROC) determined in this study to distinguish different thresholds of RVEDVI showed an area under the curve (AUC) of 0.702 for CVP, 0.748 for PAOP, and 0.762 for PVI.

The researchers concluded that "PVI may serve as a reliable estimate of cardiac preload status in patients undergoing OLT, explicitly, higher PVI values correlated with lower RVEDVI values," so that "an increase in ventricular preload status could be inferred from a decrease in PVI during OLT." They also noted that "RVEDVI was better correlated with PVI than with other static filling pressure[s], such as CVP or PAOP," therefore giving a "safer, faster, and better estimate of fluid responsiveness."

The researchers noted as a limitation that the quality of the signal from which PVI is calculated is "critically based on peripheral perfusion, which may be significantly affected by factors such as extreme low cardiac output, drug-induced vasoconstriction, and hypothermia." The researchers also noted that further studies are needed to investigate the application and effectiveness of additional dynamic hemodynamic parameters such as SVV and PPV during OLT.

@MasimoInnovates || #Masimo

References
1. Lee HC, Tsai YF, Tsai HI, Chung PC, Yu HP, Lee WC, Lin CC. Pulse Oximeter-Derived Pleth Variability Index is a Reliable Indicator of Cardiac Preload in Patients Undergoing Liver Transplantation. Transplant Proc. 2016 May;48(4):1055-8.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in Evaluating Pediatric Trauma Patients

Irvine, California – July 14, 2016 – Masimo (NASDAQ: MASI) announced today that in a new study using the 1st Generation Masimo Pronto® Pulse CO-Oximeter®, which noninvasively measures total hemoglobin (SpHb®), researchers found that noninvasive and invasive measurements correlated well and that "[g]iven the rapid availability of results and the lack of requirement of venipuncture, noninvasive hemoglobin monitoring may be a valuable adjunct in the initial evaluation and monitoring of pediatric trauma patients."1

Pronto features rainbow SET technology, allowing for the noninvasive spot checking of SpHb, oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).

In the study, published online in the Journal of Trauma and Acute Care Surgery and conducted at the University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Dr. Mark Ryan and colleagues evaluated noninvasive SpHb measurement accuracy relative to current invasive and point-of-care testing in pediatric trauma patients. They performed a prospective observational trial involving 114 patients under age 17, measuring hemoglobin levels with a point-of-care device (i-STAT) and a lab analyzer (Sysmex XN Series). Noninvasive hemoglobin measurement, using 1st Generation Pronto, was performed within 15 minutes of phlebotomy.

Of the 114 patients, SpHb was successfully measured 89% of the time. Mean lab hemoglobin was 12.6 ± 1.9 and mean SpHb was 12.3 ± 1.6 (mean point-of-care hemoglobin was 12.2 ± 2.0). Bland-Altman analysis showed the limits of agreement between lab hemoglobin and non-invasive SpHb to be -2.9 and 1.9, with a mean difference of -0.49.

The researchers concluded that they were able to demonstrate "low bias and strong correlation between hemoglobin measurements using a noninvasive monitor, a point-of-care testing device, and laboratory co-oximeter in pediatric trauma patients." They noted that noninvasive SpHb testing "may be most effective in determining when invasive testing of hemoglobin is warranted."

Key limitations to the study include: the majority of the hemoglobin values measured were within normal limits; limited data on injury severity, morbidity, and mortality to understand their effects on device accuracy and precision; data is based on a convenience sample depending on availability of certified personnel; and no assessment on the effects of pre-hospital administration of intravenous fluids.

The researchers noted that "[f]urther study is required to determine the clinical utility of the [Pronto] device during the initial assessment and its accuracy in evaluating hemoglobin levels in hemodynamically unstable patients." They stated that SpHb measurements should not be relied upon alone to determine active hemorrhage or the need for transfusion, and suggested the following reasons a noninvasive measurement could not be taken in 11% of the study's participants: severe anemia; patients who were normotensive but tachycardic; patients unreadable due to the presence of nail polish; and cold extremities or low signal IQ without hemodynamic instability or anemia.

The University of Tennessee Health Science Center received equipment from Masimo to support the data collection for this study.

@MasimoInnovates || #Masimo

References
1. Ryan, Maxwell, Manning, Jacobs, Bachier-Rodriguez, Felizm, and Williams. "Noninvasive hemoglobin measurement in pediatric trauma patients." Journal of Trauma and Acute Care Surgery. DOI: 10.1097/TA.0000000000001160. E-published ahead of print.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Pronto® Pulse CO-Oximeter with SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Pronto Pulse CO-Oximeter with SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

One of the World's Leading Centers for Cardiovascular Medicine & Transplantation Adopts Masimo's SedLine® Brain Function Monitoring and O3 Regional Oximetry

NEUCHATEL, Switzerland – July 7, 2016 – Masimo (NASDAQ: MASI) announced today that Deutsches Herzzentrum Berlin (DHZB / German Heart Center Berlin) in Berlin, Germany has adopted Masimo's SedLine® Brain Function Monitoring and O3 Regional Oximetry technologies to monitor patients in the operating room and intensive care unit.

"Our non-profit hospital performs over 32,000 treatments each year. Easy access to advanced parameters and the data they provide are very important for our patients, many of whom are undergoing especially complex and critical operations," stated Prof. Dr. Hermann Kuppe, Director of the Department of Anesthesiology at DHZB. "Masimo's technology allows us to access multiple parameters quickly and noninvasively from one monitor."

SedLine brain function monitoring provides four channels of electroencephalogram (EEG) to help clinicians better understand the effects of anesthesia on the brain. SedLine monitors the effects of anesthesia and sedation by monitoring electrical activity on both sides of the brain. O3 regional oximetry provides regional oxygen saturation (rSO2) and reference arterial oxygen saturation (SpO2) information, helping clinicians detect regional hypoxemia that pulse oximetry alone can miss.

"The innovative treatment programs at Deutsches Herzzentrum Berlin have helped it to become recognized as one of the world's leading centers for cardiovascular medicine and transplantation. They have doctors, medical students, and scientific researchers from around the world apply to visit the hospital as clinical observers every year," stated Joe Kiani, Founder and CEO of Masimo. "We are happy to see them adopt our SedLine and O3 technologies and are impressed by their focus on patient safety."

DHZB is a specialist hospital dedicated to the diagnosis and treatment of cardiovascular and thoracic diseases, the implantation of mechanical circulatory support systems, and heart and lung transplantations. A cooperative partnership with Charite-Universitatsmedizin Berlin, each year the hospital performs more than 6,700 operations, including 2,400 operations using heart-lung machines. DHZB treats more than 7,200 inpatients and 24,000 outpatients annually. The hospital has 194 beds, 71 of which are in intensive care. Since 2002, DHZB has received certification by KTQ, the national quality control board, recognizing the high standard of care DHZB provides. DHZB and its subsidiaries employ 1,300 people, including 190 doctors and almost 500 nurses.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine® and O3 technologies. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine® and O3 technologies, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Deutsches Herzzentrum Berlin
Christian Maier
Phone: + 49 03 04 5931211
Email: cmaier@dhzb.de

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology, Including Continuous SpHb®

Radius-7 is the First Wearable, Tetherless, Noninvasive rainbow® Monitor

IRVINE, California – June 28, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for Radius-7® – the first and only wearable, tetherless, noninvasive rainbow® monitor. Radius-7, which connects to the Root® patient monitoring and connectivity platform, is now available in the U.S. with breakthrough Masimo rainbow® technology. With this clearance, Radius-7 with Root now enables noninvasive monitoring of more than 10 parameters, including, for the first time in a wearable device, total hemoglobin (SpHb®), a breakthrough measurement that noninvasively and continuously measures hemoglobin concentration.

Masimo Root® with Radius-7® with rainbow®
Masimo Root® with Radius-7® with rainbow®

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.1,2

Professor Christer Svensen, Professor of Anesthesiology and Intensive Care at the Karolinska Institute in Stockholm, Sweden, who has been using Radius-7 as part of a research study, commented, "We are currently performing a noninvasive continuous study monitoring respiratory rate, heart rate and saturation for all patients admitted to a surgical ward. Additionally, we are monitoring SpHb for selected postsurgical patients, which can be extremely beneficial because it can provide insight into hemoglobin trends between invasive blood samplings. Such insight may lead clinicians to confirm trends by performing blood draws sooner than they might otherwise have done, which may then suggest the need to intervene."

For the first time, it is possible to offer patients freedom of movement while providing such important monitoring, and studies have shown that patient mobility is a key factor in more rapid patient recovery.3,4 When monitoring ambulating patients, Radius-7 communicates to Root at the bedside and thereby to Masimo Patient SafetyNet to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters. Radius-7 is lightweight, weighing only 0.34 lbs, and attaches to the arm, thus allowing untethered monitoring whether a patient is in or out of bed – which also reduces the need for nursing assistance, as there is no need to disconnect from or reconnect to a bedside monitor. Each Radius-7 comes with two "hot-swappable" rechargeable battery modules (one with the patient, one charging), each with a battery life of 12 hours, minimizing monitoring interruption.

"Never before could patients be monitored for such key parameters as continuous SpHb, which can help clinicians make more timely and informed blood management decisions, while patients are fully mobile. Previous wearable patient monitors were hampered by a limited range of measurements and false alarms due to motion," said Joe Kiani, Founder and CEO of Masimo. "Root with Radius-7 with rainbow SET, coupled with Patient SafetyNet for mobile clinician notification, is now an even more versatile and powerful monitoring system, all while promoting freedom of patient movement and quicker recovery times."

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@MasimoInnovates || #Masimo

References
1. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9. 2.
2. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.
3. Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
4. Ronnenbaum J, Weir J, Hilsabeck T. Earlier mobilization decreases length of stay in the intensive care unit. J Acute Care Phys Ther. 2012;3(2):204-210.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Radius-7®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Radius-7®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New SunTech Medical CT40 Vital Signs Device to Feature Masimo SET® Pulse Oximetry Technology

NEUCHATEL, Switzerland and EYNSHAM, England – June 23, 2016 – Masimo (NASDAQ: MASI) and SunTech Medical, a Halma (LSE:HLMA) company, jointly announced today the integration of Masimo SET® pulse oximetry technology into SunTech's CT40, a next generation spot-check vital signs device.

Masimo Signal Extraction Technology (SET®) Measure-through Motion and Low Perfusion pulse oximetry measures oxygen saturation (SpO2), pulse rate, and perfusion index. Masimo SET® has been shown to significantly reduce false alarms and accurately monitor for true alarms1,2 and is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world.

The SunTech CT40 is an ideal, affordable solution for clinical-grade spot-check measurements of blood pressure, temperature and pulse oximetry in hospitals and clinics. Ambulatory care, long-term care and low-acuity hospital departments can easily implement this versatile, user-friendly vital signs device that offers both advanced features and digital connectivity. The modular design allows clinicians to easily make adaptations to the device while in the field, adding thermometry, SpO2 and Wi-Fi as needed. Other advanced features include the ability to transmit measurement data directly from the device, in accordance with HL7 messaging protocols, as well as BP Averaging Mode - an increasingly important component of accurate blood pressure measurement, as evidenced by the recently published SPRINT Study from the National Institutes of Health (NIH), which specified that a mean of three office BP measurements would be used to establish target BPs for Standard Group participants.3

"Both SunTech and Masimo share industry-leading technologies within our respective areas of expertise," said Kenny Andersen, VP of Strategic Product Development at SunTech Medical. "Partnering with them on our next-generation vital signs platform is a very natural strategy. Masimo SET pulse oximetry is the benchmark for clinical performance, just as SunTech Advantage technology is for blood pressure. We look forward to a long and successful partnership."

Rick Fishel, Masimo's President of Worldwide OEM Business and Strategic Development, stated, "SunTech Medical is a recognized global leader and worldwide supplier of non-invasive blood pressure measurement technology. Combining best-in-class measurement technologies that provide superior performance, accuracy, and affordability, in flexible and cost effective monitors, supports our organizations' mutual vision to offer solutions that help clinicians improve patient outcomes and reduce the cost of healthcare delivery. We are very pleased to partner with SunTech Medical and that Masimo SET pulse oximetry is the preferred pulse oximetry offering in the highly versatile and cost-effective SunTech CT40 monitor."

The SunTech CT 40 with Masimo SET® technology has a CE Mark. It is not FDA cleared and is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Shah N, Ragaswamy HB, Govindugari K, Estanol L "Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers". J Clin Anesth. 2012 Aug;24(5):385-91.
2. Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2.
3. The SPRINT Study Research Group. The design and rationale of a multi-center clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT). Clin Trials. October 2014; 11(5): 532-546.

About Masimo
SunTech Medical, a Halma company, has been the preeminent supplier of clinical-grade blood pressure monitoring products and technologies for nearly 30 years. More than 75 companies trust SunTech Medical's OEM non-invasive blood pressure solutions for their patient monitoring needs. SunTech Medical produces the leading cardiac stress test blood pressure monitor and is the world's foremost manufacturer of ambulatory blood pressure monitoring products. SunTech Medical also offers solutions for in-office blood pressure monitoring as well as a complete line of blood pressure cuffs designed for general and specific applications.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET® pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET® pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

SunTech Medical
Elliott Holloway
Phone: (919) 654-2366
Email: eholloway@suntechmed.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for O3 Regional Oximetry

Irvine, California - June 13, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.

Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor
Masimo Root® with O3 Regional Oximetry and SedLine® Brain Function Monitoring

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. In a study on 27 subjects published in Anesthesia and Analgesia in 2014, Dr. Daniel Redford of the University of Arizona compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO2) through induced hypoxia.1 O3 regional oximetry provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1%.1 This study did not require that end tidal carbon dioxide (EtCO2) levels be fixed in the study protocol, allowing the rSO2 measurement to be responsive to changes in tissue oxygen saturation due to changes in CO2 in the blood. Follow up studies with O3 extended the subject pool to 74 subjects and demonstrated that O3 maintained its absolute and relative accuracy.2

"O3 regional oximetry delivers again on Masimo's technical prowess and gives clinicians access to valuable, accurate data about cerebral oxygen saturation," stated Joe Kiani, Founder and CEO of Masimo. "With the addition of O3 regional oximetry to the Root platform, clinicians can simultaneously access rSO2 and other measurements including SedLine brain function monitoring, Masimo SET SpO2, PVI, and SpHb monitoring – all in one monitoring platform."

O3 regional oximetry is currently intended for use with adults weighing 40 kg (88 lbs) or greater.

@MasimoInnovates || #Masimo

References
1. Redford D, Paidy S, Kashif F. Absolute and Trend Accuracy of a New Regional Oximeter in Healthy Volunteers During Controlled Hypoxia. Anesth Analg. 2014 Dec;119(6):1315-1319.
2. Masimo FDA submission data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3 Regional Oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 Regional Oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Full Market Release of Next Generation SpHb® Spot Check Pronto®

NEUCHATEL, Switzerland – June 8, 2016 – Masimo (NASDAQ: MASI) announced today the full market release outside the U.S. of the Pronto® Pulse CO-Oximeter® with Next Generation SpHb® Spot Check technology. Next Generation Pronto features rainbow SET technology, for noninvasive spot checking of total hemoglobin (SpHb), oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).

Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor
Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor

In addition to the Next Generation SpHb technology, Masimo has also released the rainbow® DCI®-mini reusable sensor to accompany the Pronto. The DCI-mini is a universal sensor usable on patients greater than 3 kg, making Pronto an even more versatile solution.

The Next Generation SpHb technology in Pronto offers motion tolerance and a 40% reduction in time to display SpHb results. Field accuracy has been improved in the range of 6 to 11 g/dL, and is comparable to certain portable invasive point of care devices.

"This is a significant enhancement to the noninvasive measurement we introduced 7 years ago," stated Joe Kiani, Founder and CEO of Masimo. "Since then, all of the clinical outcome studies we're aware of on our continuous SpHb technology have been positive,1-3 which is something that couldn't be said for standard pulse oximetry before the introduction of Masimo SET SpO2. We will continue to improve SpHb until it has the same measure-through motion and low perfusion performance as our SET SpO2 technology."

An upgrade program will be available for qualified existing Pronto customers. Pronto with Next Generation SpHb and the DCI-mini reusable sensor have not received FDA 510(k) clearance and are not currently available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Ehrenfeld JM, Henneman JP, Bulka CM, Sandberg WS. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial .2014. J Blood Disorders Transf. 5:237.
2. Awada WN, Mohmoued MF, Radwan TM, Hussien GZ, Elkady HW. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Dec;29(6):733-40.
3. Ponsonnard S, Yonnet S, Marin B, Cros J, Ben Miled S, Nathan N. "Continuous Hb and plethysmography variability index (PVI) monitoring is associated to a decreased mortality at the scale of a whole hospital." Proceedings of the European Society of Anaesthesiology's Euroanaesthesia 2015 Annual Congress, May 30-June 2, Berlin, Germany, 16AP3-2, Room A1 – Poster Abstract Presentation Session, e-Board 8.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Pronto® Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Pronto Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

One of India's Premier Maternal Care Specialists, Motherhood Hospitals, Standardizes on Masimo SET® Technology

Bangalore, India and Irvine, California - June 2, 2016 - Masimo (NASDAQ: MASI) announced today that Motherhood Hospitals, a maternal care specialist with five hospitals in three cities in India, has standardized on Masimo SET® (Signal Extraction Technology®) pulse oximetry at all locations. Motherhood Hospitals will also be screening for Critical Congenital Heart Disease (CCHD) using Masimo's technology.

"We evaluated several technologies and found Masimo SET pulse oximetry to be the most reliable even in the most challenging conditions," said Dr. Mohammed Rehan Sayeed, Chairman, Motherhood Hospitals. "This entire standardization exercise was driven by the clinical staff."

Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry measures oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI), and helps clinicians monitor more than an estimated 100 million patients a year.1 In a study of newborns, researchers found CCHD was identified by physical examination alone 63% of the time, and when Masimo SET® pulse oximetry was added to the physical exam screening, researchers found that clinicians were able to identify CCHD 83% of the time - a 31% increase.2

"We are happy to see the team at Motherhood Hospitals, which conducts research into how to improve the health and well-being of neonates in India, select our SET technology," said Joe Kiani, Founder and CEO of Masimo. "We hope to work with Motherhood Hospitals to standardize universal screening for CCHD in newborns. We are seeing more and more hospitals in this region of the world realize the important role reliable pulse oximetry plays in patient care and safety."

Motherhood Hospitals, a premium birthing boutique, provides a variety of services to expecting women and newborns in India, specializing in obstetrics, gynecology, neonatology, pediatrics, fetal medicine, fertility, and cosmetology. At their combined locations in Bangalore, Chennai, and Hyderabad, they perform over 6,000 deliveries annually.

@MasimoInnovates || #Masimo

References
1. Masimo data on file.
2. de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganäs L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Showcase Next Generation SedLine® Brain Function Monitor at 2016 Euroanaesthesia Congress

SedLine, Which Helps Clinicians Improve Anesthetic Management, Receives CE Mark

Neuchatel, Switzerland – May 26, 2016 – Masimo (NASDAQ: MASI) announced today the CE mark and scheduled full market release of Next Generation SedLine® Brain Function Monitoring technology at the European Society of Anaesthesiology's (ESA) 2016 Euroanaesthesia Congress in London, England.

Masimo Root® with Next Generation SedLine®
Masimo Root® with Next Generation SedLine®

Next Generation SedLine enhances how Masimo's processed EEG parameter, the Patient State Index (PSI), responds in challenging situations, addressing many of the concerns raised with quantitative EEG while bolstering brain function monitoring's support of anesthetic management.

Next Generation PSI uses Masimo's breakthrough Parallel Engines and Adaptive Signal Processing technology and provides the following enhancements:

  • Less susceptibility to electromyography (EMG) interference by extracting a clearer EEG signal even in the presence of EMG
  • Improved PSI performance in low power EEG cases

These improvements build upon the existing benefits of SedLine technology:

  • Four simultaneous EEG leads to enable continuous assessment of both sides of the brain
  • Density Spectral Array (DSA) offers easy-to-interpret, high-resolution display of bi-hemispheric activity
  • Multiple screen views expand information while enabling customization in the OR and ICU
  • Electrocautery resistance

"We are delighted to unveil Next Generation SedLine," said Joe Kiani, Founder and CEO of Masimo. "Next Generation PSI takes advantage of Masimo's signal processing prowess and promises to do for brain function monitoring what SET did for pulse oximetry."

Next Generation SedLine has not received FDA 510(k) clearance and is not currently available for sale in the United States.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Two Fire Departments Honored for Excellence in Emergency Medical Services

Fire-Service Based EMS Awards Presented at 28th Annual National Fire and Emergency Services Dinner

Washington, DC and Irvine, CA – May 19, 2016 – The Congressional Fire Services Institute (CFSI) and Masimo (NASDAQ: MASI) honored two fire departments for best practices and innovative solutions in the delivery of emergency medical services with the Excellence in Fire Service-Based EMS Award. The award presentation took place on May 5th in Washington, DC. Masimo is proud to be a co-sponsor of this award.

  • The Olathe Fire Department in Olathe, Kansas, established the Mobile Integrated Health (MIH) team to provide better treatment in the field for patients. With the support of local government, community partners, and the Olathe Medical Center, the MIH team reduced the number of patient transports to emergency rooms, monitored the progress of these patients, and scheduled follow-up visits for evaluation and continued treatment.
  • Kittitas Valley Fire and Rescue (KVFR) in Kittitas, Washington, implemented new programs that are reducing demand for emergency services while providing better care and treatment for its citizens. KVFR has launched a community paramedicine program to provide alternative medical care options to alleviate pressure on the 911 system and improve patient outcomes. They conduct educational programs for students, law enforcement, and other community members that address the dangers of alcohol and drug abuse. In addition, KVFR has developed a new fee structure and an educational program to address a rising call volume for non-injury lift assistance requests at assisted living facilities.

"CFSI takes great pride in co-sponsoring the Excellence in Fire Service-Based EMS Awards with Masimo," said Dr. William F. Jenaway, Ph.D., President of CFSI.  "Through this awards program, we are able to recognize innovations in the delivery of emergency medical services throughout the nation.  The recipients of the 2016 award – Kittitas Valley (WA) Fire and Rescue Department and the Olathe (KS) Fire Department – certainly demonstrated themselves worthy of this recognition by developing new programs to enhance their delivery of emergency medical services. Congratulations to both departments."

"Firefighters and emergency services personnel are our heroes. They put their lives on the line for us every day and we want to make sure they have the technology and community support they need to keep them safe and help them better care for the citizens they protect," said Joe Kiani, Founder and CEO of Masimo. "Masimo is honored to co-sponsor this awards program with CFSI and to recognize these two departments for their innovative achievements."

Approximately 1,600 fire and emergency services leaders attended the 28th Annual National Fire and Emergency Services Dinner to pay tribute to the dedication and commitment of the nation's fire and emergency services providers. Hosted by CFSI, the annual dinner benefits the mission of the nonprofit policy organization, which is designed to educate members of Congress about fire and life safety issues. This year's guest speaker was the Honorable Tom Vilsack, U.S. Secretary of Agriculture.

The Excellence in Fire Service-Based EMS Awards Program was established in 2010 to recognize volunteer, career, and combination fire departments for excellence in and enhancements to the delivery of emergency medical services. By showcasing their best practices, the awards program provides ideas for other fire departments to consider implementing as they seek to improve their fire service-based EMS systems.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

CFSI
Bill Webb, Executive Director
Phone: (202) 371-1277
Email: bwebb@cfsi.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Reports First Quarter 2016 Financial Results

Q1 2016 Highlights (compared to Q1 2015):

  • Total revenue, including royalties, rose 10.8% to $171.2 million
  • Product revenue rose 10.8% to $163.3 million
  • Masimo rainbow® revenue rose 39.2% to $16.9 million
  • SET® and rainbow® SET® units shipments were 46,300
  • GAAP net income of $27.6 million, or $0.53 per diluted share versus $20.5 million, or $0.38 per diluted share in the year-ago period

Irvine, California, May 4, 2016 – Masimo (NASDAQ: MASI) today announced its financial results for the first quarter ended April 2, 2016.

First quarter 2016 product revenues rose 10.8% to $163.3 million, compared to $147.4 million for the first quarter of fiscal year 2015, and total revenue, including royalties, rose 10.8% to $171.2 million, up from $154.5 million for the first quarter of fiscal year 2015.

The company's worldwide direct product revenue in the first quarter of 2016 rose by 12.7% compared to the same period in 2015 and represented 86.3% of product revenue. OEM sales, which accounted for 13.7% of product revenue, rose by 0.2% to $22.3 million in the first quarter of 2016 compared to the same period in 2015. Revenue from sales of Masimo rainbow® products rose by 39.2% to $16.9 million in the first quarter of 2016, compared to the same period in 2015.

GAAP net income for the first quarter of 2016 was $27.6 million, or $0.53 per diluted share, compared to GAAP net income of $20.5 million, or $0.38 per diluted share, in the first quarter of 2015. During the first quarter of 2016, the company shipped 46,300 SET® pulse oximeters and rainbow® pulse CO-Oximeters, excluding handheld units. Masimo estimates its worldwide installed base as of April 2, 2016 to be 1,438,000 units, up 7.3% from 1,340,000 units as of April 4, 2015.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "We are happy to report results for the first quarter exceeded our expectations. Our strong revenue growth is the result of increasing demand for both our SET® Pulse Oximetry and rainbow SET Pulse CO-Oximetry technologies, as well as increasing demand from our new products. Given the strong Q1 results and our continued optimism about the rest of the year, we are happy to be in a position to raise our full year 2016 financial guidance."

During the first quarter of 2016, the company generated $18.8 million in cash from operations and as of April 2, 2016, total cash and cash investments were $139.9 million compared to $132.3 million as of January 2, 2016. Also, during the first quarter of 2016, the company repurchased approximately 1.1 million shares of stock for $42.9 million.

2016 Financial Guidance
Masimo today is updating its 2016 financial guidance. Masimo now expects fiscal 2016 total revenues to be approximately $677 million, up from $670 million. Total fiscal 2016 product revenues are now expected to be approximately $647 million, up from $640 million, while royalty revenue expectations have not changed from the previous estimate of approximately $30 million. Masimo now also expects its fiscal 2016 GAAP earnings per diluted share to be $1.83, up from $1.69. Masimo will provide additional financial information during the conference call today. Each of the components of Masimo's guidance set forth above is an estimate only and actual performance could differ.

Conference Call
Masimo will hold a conference call today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results. A live webcast of the call will be available online from the investor relations page of the company's website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 95558540. After the live webcast, the call will be available on Masimo's website through May 18, 2016. In addition, a telephonic replay of the call will be available through June 3, 2016. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 95558540.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.


Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our expectations for full fiscal year 2016 total, product and royalty revenues and GAAP earnings per diluted share; demand for our products; anticipated revenue and earnings growth; our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies and reduce the cost of care; and demand for our technologies. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET® and Masimo rainbow® SET® products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the amount and type of equity awards that we may grant to employees and service providers in the future; our ongoing litigation and related matters; and other factors discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission ("SEC"), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact:

Eli Kammerman
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

 

One of France's University Hospitals Adopts Masimo Radical-7®, Including SpHb®, PVI®, and SET® Pulse Oximetry

Neuchatel, Switzerland – April 21, 2016 – Masimo (NASDAQ: MASI) announced today that Centre Hospitalier Universitaire (CHU) de Limoges, in Limoges, France has installed Masimo's Radical-7®, including noninvasive, continuous hemoglobin (SpHb®), Pleth Variability Index (PVI®), and SET® pulse oximetry technology, to monitor surgical patients and critical patients in the post-anesthesia care unit and intensive care unit.

"For three years, we tested SpHb and PVI on every surgical patient in our facility and then compared this data to the previous period without this technology," said Professor Nathalie Nathan, Head of the Department of Anesthesiology at CHU Limoges. "In this retrospective review of before and after periods across the entire hospital, in different clinical settings and with many different practitioners, we found that there was a notable reduction in mortality in surgeries lasting longer than 2 hours and patients in the 60+ age range."

SpHb is a breakthrough measurement that noninvasively and continuously measures total hemoglobin in the blood, and offers real-time visibility into changes – or lack of changes – in hemoglobin between invasive blood samples. PVI is a measure of dynamic changes in Perfusion Index (PI) that occur during one or more complete respiratory cycles, and may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. PVI is noninvasive, easily obtained and has no incremental procedural cost.

"According to the World Health Organization, France ranks number one in the world in patient safety. For over 40 years, CHU Limoges has been recognized as a leading hospital in France for patient care, training, research and innovation," stated Joe Kiani, Founder and CEO of Masimo. "We are impressed with the format of this three-year evaluation and happy to see Limoges incorporate SpHb and PVI in the care of their patients."

CHU Limoges is a university hospital that includes four locations and one nursing home. Dupuytren (866 beds) hosts an emergency department, Jean Rebeyrol (459 beds) handles rehabilitation patients, Cluzeau (59 beds) specializes in respiratory diseases, diabetes, endocrinology and metabolic diseases, and Mother & Child (197 beds) specializes in pediatric and gynecological emergencies.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2", pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's SpHb®, PVI®, and SET® technologies. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's SpHb®, PVI®, and SET® technologies, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Report First Quarter 2016 Financial Results after Market Close on Wednesday, May 4

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., April 20, 2016 – Masimo (NASDAQ: MASI) announced today that it will release financial results for the first quarter ended April 2, 2016, after the market closes on Wednesday, May 4, 2016. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 95558540. After the live webcast, the call will be available on Masimo's website through May 18, 2016. In addition, a telephonic replay of the call will be available through June 3, 2016. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 95558540.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Investor