Current News

Date Title
03/04/2019 Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring
02/25/2019 New Case Series Investigates the Combined Use of Masimo SedLine® Brain Function Monitoring and O3® Regional Oximetry During Cardiac Surgery
02/11/2019 Masimo Announces Doctella™, a Secure Cloud-based Patient Engagement and Remote Care Automation Platform
01/28/2019 Masimo Announces FDA Clearance of RRp®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter
01/22/2019 Masimo Announces U.S. Launch of Iris® Device Management System
01/07/2019 Julie A. Shimer Ph.D. Joins Masimo's Board Of Directors
12/12/2018 Masimo Founder and CEO Joe Kiani Honored with First IP Champion Award
11/12/2018 International Consensus Statement on Postoperative Anemia Management Recommends Noninvasive Hemoglobin Measurement Including Masimo SpHb®
10/25/2018 Masimo Announces FDA Clearance for Masimo RD Sensors with Improved Accuracy Specifications for SET® Pulse Oximetry
10/17/2018 Bassett Medical Center of New York Adopts Masimo Patient SafetyNet™
10/01/2018 New Study Evaluates the Ability of Masimo ORi™ to Help Clinicians Reduce Hyperoxemia in Mechanically Ventilated ICU Patients
09/10/2018 Masimo Announces FDA Clearance of the rainbow Acoustic Monitoring® RAS-45 Sensor for Infant and Neonatal Patients
09/05/2018 New Study Compares Two Methods of Guiding Goal-Directed Fluid Therapy, Noninvasive Masimo PVi® and Invasive Esophageal Doppler
08/27/2018 New Study Evaluates the Ability of Masimo ORi™ to Reflect Oxygenation During Moderate Hyperoxia
08/13/2018 New Study Investigates the Utility of Home Monitoring Using Masimo SET® Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies
08/02/2018 H Michael Cohen Joins Masimo's Board of Directors
07/16/2018 New Study Investigates the Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorectal Surgery
07/09/2018 Masimo Announces Vital Signs Check Application for the Root® Patient Monitoring and Connectivity Platform
07/02/2018 New Study Investigates the Utility of Masimo ORi™ (Oxygen Reserve Index) in Providing Early Detection of Blood Oxygenation Decrease During One-Lung Ventilation
06/26/2018 United Arab Emirates Ministry of Health & Prevention Adopts National CCHD Newborn Screening Program Using Masimo Rad-97™ Pulse CO-Oximeters® with Eve™
06/18/2018 Masimo and PositiveID Announce the U.S. Release of TIR-1™
06/11/2018 New Study Investigates the Utility of Masimo SedLine® Patient State Index in Monitoring Anesthesia Depth of Patients with Healthy and Cirrhotic Livers
06/04/2018 New Study Investigates the Utility of Continuous Noninvasive Hemoglobin Measurement with Masimo SpHb® for Reflecting Real-time Iatrogenic Hemodilution During Incremental Fluid Administration
05/21/2018 Women's Tennis Association to Use Masimo MightySat™ Fingertip Pulse Oximeters to Advance Player Health and Performance
05/14/2018 New Study Investigates the Economic Impact and Utility of Continuous Noninvasive Hemoglobin Measurement with Masimo SpHb® in Reducing Unnecessary Blood Transfusions
05/07/2018 Masimo SET® Pulse Oximetry Helps Form Basis of Utah Senate Resolution on Postoperative Oxygen Saturation Home Monitoring for Patients Prescribed Opioids
05/02/2018 Masimo Reports First Quarter 2018 Financial Results
05/01/2018 Masimo O3® Regional Oximetry and SedLine® Brain Function Monitoring Power Two Investigations into Postoperative Delirium Presented at IARS
04/19/2018 New Study Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices
04/10/2018 Masimo Announces CE Marking of Rad-97™ Pulse CO-Oximeter® with Integrated NomoLine™ Capnography
04/02/2018 Masimo Announces UniView™
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

 

Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring

Next Generation SedLine Now Available for Use on Patients 1-18 Years Old in CE Mark Countries

Neuchatel, Switzerland – March 4, 2019 – Masimo (NASDAQ: MASI) announced today the CE marking of Next Generation SedLine® brain function monitoring for pediatric patients (1-18 years of age). With this clearance, the benefits of Next Generation SedLine are available for all patients one year old and above in CE mark countries. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EEG) signals.

Masimo Root with Next Generation SedLine
Masimo Root® with Next Generation SedLine®

SedLine uses a pediatric-specific signal processing engine to improve performance of Masimo's processed EEG parameter, the Patient State Index (PSi), when monitoring pediatric patients one year old and above. The use and monitoring of anesthesia on pediatric patients can differ from its use on adults.1-2 Maintaining an appropriate level of anesthesia is key to preventing anesthesia-related events and enabling faster recovery.3 The PSi in SedLine, driven by its pediatric-specific engine, is uniquely suited to helping clinicians interpret the EEGs of this challenging population.

In addition to the newly announced pediatric-specific signal processing when used on pediatric patients, Next Generation SedLine offers significant improvements over original SedLine, including:

  • A PSi with less susceptibility to electromyography (EMG) interference.
  • A Multitaper Density Spectral Array (DSA), which may enhance visibility of EEG features.

Joe Kiani, Founder and CEO of Masimo, said, "Next Generation SedLine is doing for brain function monitoring what Masimo SET® did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed."

Next Generation SedLine has received FDA clearance for adults but is not currently indicated for pediatric patients in the USA.

@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. Davidson et. Current Anesthesiology Reports 3. 1 (2013): 57-63.
2. Cornelissen L et al. Elife 4 (2015): e06513.
3. Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260.
4. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
5. 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.
6. 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.
7. 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.
8. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9. 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.
10. Estimate: Masimo data on file.
11. 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 Case Series Investigates the Combined Use of Masimo SedLine® Brain Function Monitoring and O3® Regional Oximetry During Cardiac Surgery

Doctella Facilitates Pre- and Post-hospital Care at Home with Customizable, Interactive CarePrograms™ That Utilize Patient-reported and Physiological Data

Neuchatel, Switzerland – February 25, 2019 – Masimo (NASDAQ: MASI) announced today the findings of a series of four clinical cases, recently published in the Canadian Journal of Anesthesiology, in which researchers at the University of Montreal found that combined use of Masimo SedLine® brain function monitoring and O3® regional oximetry assisted their understanding and management of cerebral desaturations during cardiac surgery.1

Masimo Root with SedLine and O3
Masimo Root&reg with SedLine&reg and O3&reg

Drs. Etienne Couture, Alain Deschamps, and Andr Denault hypothesized that the addition of processed electroencephalography (pEEG) using Masimo SedLine's processed EEG parameter, the Patient State Index (PSi), to a previously developed clinical management algorithm based on Masimo O3 near-infrared spectroscopy (NIRS), could help guide the management of cerebral desaturation episodes. In this series of case studies, they describe the impact of combining the modalities on the clinical management of four patients undergoing cardiac surgery. The researchers then outline a series of scenarios that enumerate possible causes of desaturation based on various combinations of changes in NIRS and pEEG, as well as changes in related monitoring data available via SedLine, such as the density spectral array (DSA) and spectral edge frequency (SEF). Possible causes include a change in cerebral blood flow, cerebral hypoperfusion, cardiogenic shock, hypoxemia, a change in the anesthetic state, hyperthermia, and seizure. In the four cases, more insight into the likely cause of a desaturation episode helped guide how clinicians responded during surgery.

The researchers concluded, "Combining both NIRS and pEEG allows for a much more nuanced understanding of the etiology of cerebral desaturation. Future studies are needed to investigate if the combination of both modalities is more prognostic than each alone. Every cerebral oxygen desaturation is not equal."

Dr. Denault commented, "By combining NIRS and pEEG we were able to have a better appreciation of the significance of brain desaturation, and using Masimo O3 and SedLine in particular to obtain those measurements provided a number of advantages. The additional brain monitoring parameters available through Masimo SedLine, such as the DSA and SEF, play an important role in our protocol, helping to provide additional insight. And, perhaps most significantly, both SedLine and O3 can be used simultaneously on the same Masimo Root® monitoring hub, making it easier to view and interpret the combined data and thus streamlining our use of the desaturation protocol and workflow during surgery."

Masimo O3 is not currently indicated for somatic use.

@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. Couture EJ, Deschamps A, and Denault AY. Patient management algorithm combining processed electroencephalographic monitoring with cerebral and somatic near-infrared spectroscopy: a case series. Can J Anesth. 2019. https://doi.org/10.1007/s12630-019-01305-y.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. 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.
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. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. Estimate: Masimo data on file.
9. 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 Doctella™, a Secure Cloud-based Patient Engagement and Remote Care Automation Platform

Doctella Facilitates Pre- and Post-hospital Care at Home with Customizable, Interactive CarePrograms™ That Utilize Patient-reported and Physiological Data

Irvine, California – February 11, 2019 – Masimo (NASDAQ: MASI) announced today the launch of Doctella™, a home-based patient engagement and remote care automation platform. Doctella provides a complete end-to-end home care solution, allowing clinicians to create and manage treatment plans, patient schedules, and patient data flow using automated, customizable CarePrograms™, home device data aggregation, and a web-based provider dashboard. CarePrograms are delivered to patients' smartphones via an app (available for both iOS® and Android® devices) and dynamically update based on patient input, both self-reported data and physiological data collected by connected monitoring devices.

CarePrograms, configurable via the web-based provider portal, represent a digital, dynamic, and intelligent upgrade to traditional home care plans. Data pushed to patients can include coaching, guidance, and recommendations, such as notifications to remind patients to take medications, connect monitoring devices, or exercise. In turn, the Doctella secure cloud pulls and processes data entered manually by patients – such as patient-reported outcomes and textual responses, with the ability to provide consent through the app – as well as data gathered from connected devices, such as the Masimo MightySat™ Rx fingertip SET® pulse oximeter and the Masimo Rad-97™ rainbow SET™ Pulse CO-Oximeter®, which can act as a Bluetooth®-based hub, capable of pulling in data from a variety of Masimo and third-party devices. Doctella incorporates these data into logic-driven protocols and algorithms that can be customized to meet the needs of clinicians and institutions.

The Doctella provider portal allows clinicians to keep track of various physiological events (such as oxygen desaturations) and behaviors (such as confirming having taken medication as prescribed) for each patient, helping clinicians identify when intervention may be needed and how to prioritize the needs of multiple patients. Through such automation, institutions can more easily deploy home care monitoring at scale while helping clinicians remain abreast of important developments in patient condition. The provider portal can also collect population-level health data to help clinicians gauge the efficacy of various treatment protocols and develop new plans using data-driven decisions and strategy.

Peter Pronovost, MD, PhD, Chief Clinical Transformation Officer at University Hospitals, Ohio, and one of the co-developers of Doctella, said, "As healthcare seeks to improve value, it needs to change its narrative from success being patients healing in the hospital to patients being healthy at home. Doctella helps to accelerate that journey by making sure that patients receive safe, evidence-based care in the healing environment of their own home." Dr. Pronovost recently spoke about the need to change the healthcare narrative at the 2019 World Patient Safety, Science, and Technology Summit.

Patient monitoring at home is an important and increasingly recognized part of providing quality patient care. Home care may be beneficial, for example, for patients with conditions like chronic obstructive pulmonary disease (COPD) and post-surgical patients recuperating at home using prescribed opioids. With proper care pre- and post-surgery at home, patients are expected to do better and help reduce the rate of avoidable hospital readmissions.

Joe Kiani, Founder and CEO of Masimo, said, "Masimo has always sought ways to help caring clinicians automate and improve the care of their patients. Doctella extends our role into perioperative care outside the hospital and in the home. With customized, automated care plans which funnel patient data to clinicians while helping them prioritize and intervene as needed, Doctella brings clinicians and patients together comprehensively and securely with a complete, end-to-end solution."

Masimo Doctella will be debuted during the HIMSS19 Conference in Orlando, Florida starting February 11, at Masimo's booth 6259. To schedule a meeting or learn more, please contact sales@masimo.com.

@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;Jan 8;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 A 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 FDA Clearance of RRp®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter

Masimo MightySat Rx, Now Also Indicated for Use at Home, is the First Fingertip Pulse Oximeter with SET® and the First to Measure Respiration Rate

Irvine, California – January 28, 2019 – Masimo (NASDAQ: MASI) announced today FDA clearance of the measurement of respiration rate from the pleth (RRp®) on the MightySat™ Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment. The addition of RRp to MightySat Rx, which also measures functional oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi®), makes it a more thorough and versatile spot-check solution.

Masimo MightySat Rx with RRp
Masimo MightySat™ Rx 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 rate per minute, or being fitted with chest leads or straps that can be inconvenient. With RRp, respiration rate can conveniently be measured using the same optical sensor that measures SpO2, PR, Pi, and PVi. RRp is provided 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.

With the introduction of RRp to the U.S., Masimo now offers clinicians more ways to accurately measure breathing rate than ever, helping to ensure they have the right tools for each patient scenario. RRp on MightySat Rx offers a convenient, fast, and portable option, adding to the portfolio of respiratory solutions from Masimo that includes continuous, acoustic respiration rate monitoring using RRa® and capnography-based solutions using NomoLine®.

Alongside RRp, PVi, PR, and Pi, MightySat Rx features the same Measure-through Motion and Low Perfusion™ SET® pulse oximetry available in a variety of bedside Masimo and OEM monitors. SET® has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies,1 is estimated to be used on more than 100 million patients a year,2 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.3 The benefits of SET® are maximized by choosing the correct sensor type for each use scenario: adhesive sensors for continuous monitoring, reusable sensors for short-term monitoring, and MightySat Rx fingertip oximeters for spot-check measurements.

MightySat Rx is small and light, weighing less than 100 grams (with batteries), but also durable and long-lasting, with an IP23 ingress rating (protected from water spraying from up to 60 degrees from vertical) and providing approximately 1,800 spot-checks with each set of 2 AAA batteries. Available in both black and white, MightySat offers a high-resolution color display, including display of plethysmographic waveforms, as well as a Bluetooth® wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements.

@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. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview. 4. 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.
5. 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.
6. 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.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. 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.

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 U.S. Launch of Iris® Device Management System

Iris Device Management System Facilitates Remote Management of Masimo Point-of-care Devices Throughout the Hospital

Irvine, California – January 22, 2019 – Masimo (NASDAQ: MASI) announced today the U.S. launch of Iris® Device Management System (Iris DMS), an automation and connectivity solution designed to streamline management of Masimo devices used throughout a hospital system.

Masimo Iris Device Management System
Masimo Iris®
Device Management System

Iris DMS is designed to address the challenges of maintaining many patient monitors in a complex hospital environment. Iris DMS securely connects over a hospital's existing network to all connected Masimo devices to provide an easy-to-use dashboard that allows Biomedical Engineers and IT professionals to view detailed diagnostic information about connected Masimo devices at a glance, without the need to physically interact with each device. Iris DMS supports remote software upgrades to ensure all devices stay up to date, easily and efficiently. Patient profiles, policy files, and network settings can be distributed to multiple devices in a single step, simplifying device management. In addition, connected devices routinely "ping" Iris DMS, allowing users to quickly identify any operational issues with any single Masimo device using the intuitive display of near real-time connection status.

Joe Kiani, Founder and CEO of Masimo, said, "More and more clinicians are recognizing the benefits of providing continuous Masimo patient monitoring, not just during surgery or in the ICU, but in all medical-surgical wards, especially for patients on opioids. Masimo patient monitoring devices are more powerful and full-featured than ever, but as a result their software is increasingly complex. Just as with consumer tech devices, medical devices now undergo regular iterative software updates as new innovations and features become available – helping prolong their utility and augmenting their abilities – and as security patches are issued. Iris DMS not only helps Biomedical and IT professionals view detailed diagnostic information about connected Masimo devices at a glance, but helps to simplify the process of maintaining, updating, and standardizing these devices, helping clinicians and hospitals stay focused on providing the best patient care using the most up-to-date technology, not worrying about device maintenance. Iris DMS is another great example of Masimo's pursuit of holistic care solutions that improve patient outcomes and reduce costs across the continuum of care."

@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;Jan 8;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 A 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.

 

Julie A. Shimer Ph.D. Joins Masimo's Board Of Directors

Irvine, Calif. – January 07, 2019 – Masimo (NASDAQ: MASI) a global medical technology developer and manufacturer of innovative noninvasive patient monitoring technologies, announced today that Julie A. Shimer, Ph.D. has been appointed to Masimo's Board of Directors.

Dr. Shimer is currently a private investor and has over 30 years of product development experience. Dr. Shimer was President and Chief Executive Officer of Welch Allyn, from March 2007 to April 2012. Prior to Welch Allyn, Dr. Shimer served as President and Chief Executive Officer of Vocera Communications, Inc., from September 2001 through February 2007, also serving on the board of directors. Dr. Shimer also previously held executive positions at 3Com Corporation from January 2000 through August 2001, most recently serving as vice president and general manager of its networking products. Before joining 3Com, she held executive positions at Motorola, Inc., from 1993 through 1999, where she was vice president and general manager for the paging division, and prior to that post, vice president of its semiconductor products section. Dr. Shimer worked for AT&T Bell Laboratories and Bethlehem Steel Company before joining Motorola.

Dr. Shimer is a member of the Board of Directors of Netgear, Inc. (NASDAQ: NTGR), a member of the Board of Directors of Apollo Endosurgery, Inc. (NASDAQ: APEN), a member of the Board of Directors of Windstream Holdings, Corp. (NASDAQ: WIN), and a member of the Board of Directors of Avanos Medical, Inc. (NYSE: AVNS). Dr. Shimer is also a member of the Society of Women Engineers and the Institute of Electrical and Electronics Engineers. Dr. Shimer holds a B.S. degree in Physics from Rensselaer Polytechnic Institute and Master's and Doctorate degrees in Electrical Engineering from Lehigh University.

"We are delighted to welcome Dr. Shimer to Masimo's Board of Directors," said Joe Kiani, Founder, Chairman, and CEO of Masimo. "With her many years of executive leadership and board experience in the medical and communications industries and beyond, as well as her technical expertise and engineering background, she will be an invaluable addition. And I'm particularly excited to have a fellow electrical engineer on our Board."

"I'm honored to join Masimo's Board," said Dr. Shimer. "I've long admired Masimo's commitment to advancing care through innovation and I look forward to contributing to its continued success."

@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;Jan 8;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 A 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.

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

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 Founder and CEO Joe Kiani Honored with First IP Champion Award

The Intellectual Property Owners Education Foundation Promotes the Understanding of Intellectual Property Laws and Their Value to Society

Washington, DC – December 12, 2018 – Masimo (NASDAQ: MASI) Founder and CEO, Joe Kiani, was honored last night at the 2018 IPO Education Foundation Awards Dinner with the first ever IP Champion Award. The Intellectual Property Owners Education Foundation, a non-profit organization devoted to educating the public on the importance of IP to society, has been awarding an Inventor of the Year for 45 years and Distinguished IP Professional for 10 years. 2018 marks the creation of a new award, IP Champion, bestowed upon Mr. Kiani for showing "extraordinary leadership in advocating for the value of intellectual property to the progress of innovation."

Masimo Founder and CEO Joe Kiani speaking at the 2018 IPO Education Foundation Awards Dinner
Masimo Founder and CEO Joe Kiani speaking at the 2018 IPO Education Foundation Awards Dinner

Retired Chief Judge Paul Michel, formerly U.S. Circuit Judge of the U.S. Court of Appeals for the Federal Circuit and Chief Judge of that court, commented, "Serial inventor Joe Kiani built a major patient health improving company, starting from scratch at age 23, obtaining VC funding based on his patent applications when patents were strong. Later Congressional and Supreme Court interventions so sapped patent strength that he could not repeat his feat today. Reviving patents is essential to America's future since most major inventions, new jobs, and personal welfare gains and economic growth result from start-ups and small and mid-sized technology companies like Masimo. It actually saves many lives each day with its patient monitoring devices. Isn't that what we need as much today as before?"

In his acceptance speech, Mr. Kiani noted, "Without a strong IP system, Masimo would not have been able to get funding, would not have been able to stop the monopolists in our market that tried to steal it, and would not have been able to solve unsolvable problems like the development of noninvasive hemoglobin measurement. The system worked – and I want to thank the patent office and our judicial system, including the many incredible judges and juries who are able to tell truth from falsehood."

Mr. Kiani continued, "Throughout all of Masimo's growth, we haven't changed our philosophy nor our actions when it comes to intellectual property. We believe property rights are essential to a growing economy, and when it comes to a growing innovation economy, intellectual property rights are even more necessary. That's why we use our success story to remind Congress, the FTC, and anyone who will listen that when it comes to IP protection, one must take the long view. . . . If we make patents and trade secrets strong, future Masimos will also be able to raise funds to solve unsolvable problems, ones hopefully even more important for our survival and economic prosperity."

The awards dinner was held on December 11th at the National Building Museum in Washington, DC. Mr. Kiani was accompanied by his wife Sarah and guests Retired Senator Tom Harkin and his wife Ruth. David Hall, Founder and CEO of Velodyne LiDAR, was named Inventor of the 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. 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;Jan 8;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 A 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.

 

International Consensus Statement on Postoperative Anemia Management Recommends Noninvasive Hemoglobin Measurement Including Masimo SpHb®

Neuchatel, Switzerland – November 12, 2018 – Masimo (NASDAQ: MASI) announced today that a new consensus statement on postoperative anemia management was published in Anaesthesia by an international panel of clinicians specializing in patient blood management, which includes clear guidance on the use and benefits of noninvasive hemoglobin measurement.1 The statement, which discusses both spot-check and continuous measurement, references the Masimo Rad-67™ Pulse CO-Oximeter®, a spot-check device that measures noninvasive hemoglobin using Masimo SpHb®, as the example of noninvasive measurement.

Masimo Rad-67 with SpHb
Masimo Rad-67™ with SpHb®

The statement notes in part that, "The use of non-invasive continuous haemoglobin monitoring devices instead of phlebotomy may reduce blood loss, pain and discomfort for the patient, but concerns about precision limit routine clinical use. Although the debate focuses on accuracy of a single check, the reliability of non-invasive haemoglobin monitoring devices for dynamic changes over time may permit detection of occult bleeding and response to therapy."

In addition to this newest consensus statement, SpHb has recently received positive recognition from two other reputable institutions in the European anesthesiology community. Both the 2017 European Society of Anaesthesiology's (ESA) Guidelines for the Management of Severe Perioperative Bleeding2 and the 2017 Italian Ministry of Health's Blood Management Program Guidelines3 included noninvasive and continuous SpHb as a recommended tool for monitoring hemoglobin. Specifically, the ESA guidelines provided a strong recommendation that "continuous haemoglobin monitoring can be used as a trend monitor."

SpHb is available on a variety of Masimo noninvasive spot-check and continuous monitoring devices, both portable and bedside, as well as through licensed third-party devices. For continuous monitoring, these include Masimo's Rad-97™, Radical-7®, and Radius-7®. Noninvasive and continuous hemoglobin (SpHb) monitoring helps automate the patient's hemoglobin status and provides real-time visibility to changes – or lack of changes – in hemoglobin between invasive blood samples. For spot-check SpHb measurement, Masimo Pronto® is available in addition to Rad-67. Next Generation SpHb, available on these devices outside the U.S., significantly advances noninvasive hemoglobin spot-checking with improved motion tolerance, faster time to display SpHb results, and enhanced field performance in low hemoglobin ranges.

Joe Kiani, Founder and CEO of Masimo, said, "We are happy to see growing recognition, from some of the world's most renowned clinicians, institutions, and advisory bodies, of the utility and benefits of our noninvasive hemoglobin measurement technology. Studies on three continents have shown that continuous SpHb monitoring optimizes blood transfusion4-6 and in a trial with over 3,000 patients, continuous SpHb and PVi® were shown to reduce mortality 30 and 90 days after surgery.7 Never content, we continue to refine and improve SpHb and PVi, and look forward to bringing the advantages of Next Generation SpHb to additional markets and devices soon."

Rad-67 with Next Generation SpHb has not received FDA 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. 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. Munoz M, Acheson AG, Bisbe E, Butcher A, Gomez-Ramirez S, Khalafallah AA, Kehlet H, Kietaibl S, Liumbruno GM, Meybohm P, Rao Baikady R, Shander A, So-Osman C, Spahn DR, and Klein AA. An international consensus statement on the management of postoperative anaemia after major surgical procedures. Anaesthesia 2018. Doi:10.1111/anae.14358.
2. Kozek-Langenecker SA, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.
3. Vaglio S, et al. The Italian Regulatory Guidelines for the implementation of Patient Blood Management. Blood Transfus. 2017 Jul;15(4):325-328. doi: 10.2450/2017.0060-17.
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. Abstract #PR607.
5. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
6. 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.
7. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
8. 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.
9. 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.
10. 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.
11. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
12. 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.
13. Estimate: Masimo data on file.
14. 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 FDA Clearance for Masimo RD Sensors with Improved Accuracy Specifications for SET® Pulse Oximetry

Irvine, California – October 25, 2018 – Masimo (NASDAQ: MASI) announced today that RD SET™ sensors with Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry have received FDA clearance with improved SpO2 accuracy specifications for all patients > 3 kg. RD SET single-patient-use sensors with the improved accuracy specifications are now available. The new RD SET sensors' SpO2 accuracy specifications during patient motion have improved for adult, pediatric, and infant patients to 1.5% (at 1 SD), compared to previous accuracy specifications of 3%.

Masimo Radical-7 with RD SET Sensor and SET Pulse Oximetry
Masimo Radical-7® with RD SET™ Sensor and SET® Pulse Oximetry

In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. 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. Their lightweight design results in up to 84% less waste, and their sleek, recyclable packaging reduces storage and shipping space.

The clinical benefits of Masimo's revolutionary SET® pulse oximetry have been demonstrated in a variety of clinical conditions. Studies have shown:

  • Masimo SET® helped significantly reduce rates of severe retinopathy of prematurity (ROP) and the need for laser treatment.1
  • Masimo SET® enabled pulse oximetry screening for critical congenital heart disease (CCHD), helping save many full-term newborns' lives whose disease would otherwise have gone undiagnosed.2-4
  • With Masimo SET® on post-surgical wards, rescue calls and ICU transfers were reduced by 65% and 48%, respectively.5 Post-operative continuous surveillance monitoring, combined with Masimo SET®, led to zero preventable deaths or brain damage due to opioids over five years.6

Joe Kiani, Founder and CEO of Masimo, said, "We're delighted to be able to announce our continued innovation in our foundational SET® pulse oximetry. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we've been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET®, we have not allowed that to stop us from continuing our pursuit of perfecting the technology. We have significantly improved our accuracy during motion and this is just the start of further improvements in what clinicians can expect from pulse oximetry."

In addition to excellent accuracy and reliability, the SET® platform with rainbow® is also the only oximetry technology that also allows clinicians to measure physiological parameters such as total hemoglobin, carboxyhemoglobin, methemoglobin, and PVi®.

@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 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. 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.
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;Jan 8;338.
4. Ewer A et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.
5. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. Estimate: Masimo data on file.
9. 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.

 

Bassett Medical Center of New York Adopts Masimo Patient SafetyNet™ and Root® with Vital Signs Check

Cooperstown, New York and Irvine, California – October 17, 2018 – Masimo (NASDAQ: MASI) announced today that Bassett Medical Center, a 180-bed Cooperstown, New York hospital, has adopted Masimo Patient SafetyNet™ and Root® with Vital Signs Check across its 54-bed medical-surgical unit, including pediatric beds. The integrated system, extending from bedside patient monitoring and data collection to supplemental remote monitoring and notification, provides advanced monitoring, streamlines workflows, automates the integration and transfer of patient data, and keeps clinicians abreast of pertinent changes in patient condition even from afar, helping to enhance quality of care and patient safety.

Masimo Patient SafetyNet, Root, Radius-7, Radical-7, and Replica
Masimo Patient SafetyNet™, Root®, Radius-7®, Radical-7®, and Replica™

Ronette Wiley, RN, COO of Bassett Medical Center, commented, "We value this partnership with Masimo. Patient SafetyNet and the integrated Vital Signs Check capabilities of Root are already proving to be a great fit for our medical-surgical units. It's been just over a month since implementation, and already the feedback from our clinicians is positive."

In discussing several potential patient events to which their newly installed Root and Patient SafetyNet system alerted clinicians, Charles Oliver, RN, Assistant Nurse Manager at Bassett Medical Center, said of Patient SafetyNet, "This has undoubtedly prevented rapid responses, transfers and possibly even a code situation today."

Masimo Root is a powerful, expandable bedside platform that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions – in a single, clinician-centric hub. Root's plug-and-play expansion capabilities allow clinicians to simplify patient monitoring by bringing together advanced rainbow SET™ Pulse CO-Oximetry, brain function monitoring, regional oximetry, capnography, and vital signs measurements on an easy-to-interpret, customizable display, empowering clinicians with important information for making patient assessments. Vital Signs Check for Root allows clinicians to streamline and automate vital signs measurement and patient data workflows.

Masimo Patient SafetyNet is a supplemental remote monitoring and clinician notification system which allows patient monitoring data, gathered and integrated at the bedside by Root and other Masimo devices, to be accessed from central viewing stations. 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 automates the transfer of patient data, including vital signs, early warning scores (EWS), and other physiological parameters, directly to hospital electronic medical record (EMR) systems, like the Epic EMR used by Bassett Medical Center.

In a landmark study at Dartmouth-Hitchcock Medical Center in New Hampshire, researchers found that continuous monitoring of adult post-surgical patients using Masimo SET® pulse oximetry on Masimo bedside devices, in conjunction with Masimo Patient SafetyNet, resulted in a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU.1 Over five years, they achieved their goal of zero preventable deaths or brain damage due to opioids,2 and over ten years, they maintained a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increase in patient acuity and occupancy.3

Joe Kiani, Founder and CEO of Masimo, said, "We applaud Bassett Medical Center's prioritization of patient safety and are happy they are already seeing the benefits of implementing integrated Masimo systems like Root and Patient SafetyNet, designed to improve and automate care. With a solid foundation of Masimo monitoring technologies like Measure-through Motion and Low Perfusion™ SET® pulse oximetry and our advanced rainbow® parameters, and the streamlined workflows made possible by Masimo's enhanced connectivity and data integration solutions, clinicians at Bassett can remain focused more acutely than ever on delivering the best possible patient care."

@MasimoInnovates || #Masimo

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

References
1. Taenzer A 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 A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
3. McGrath S 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 9 of the top 10 hospitals listed in the 2018-19 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 http://www.masimo.com/evidence/featured-studies/feature/.

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 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.

 

New Study Evaluates the Ability of Masimo ORi™ to Help Clinicians Reduce Hyperoxemia in Mechanically Ventilated ICU Patients

Neuchatel, Switzerland – October 1, 2018 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Congress of the French Society of Anesthesia and Resuscitation (SFAR) in Paris in which researchers at CHU Angers in France investigated the ability of Masimo ORi™ (Oxygen Reserve Index) to help clinicians reduce the number of days ICU patients experience hyperoxemia while on mechanical ventilation.1 ORi, available outside the U.S., is a noninvasive and continuous parameter intended as a relative indicator of a patient's oxygen reserve during moderate hyperoxia (partial pressure of oxygen in arterial blood [PaO2] in the range of 100 to 200 mmHg). ORi can be trended and has optional alarms to notify clinicians of changes in oxygenation.

Masimo Root with Radical-7, ORi, and the RD rainbow SET Sensor
Masimo Root® with Radical-7®, ORi™, and the RD rainbow SET™ Sensor

Noting that hyperoxemia can lead to patient morbidity and mortality in ICU patients, and that oxygen saturation (SpO2) cannot detect hyperoxemia, Dr. Brochant and colleagues sought to evaluate whether ORi might be useful in helping clinicians determine when to reduce the fraction of inspired oxygen (FiO2) during oxygen therapy, so as to avoid hyperoxemia. In this initial analysis, the first 131 patients in the study, whose data were collected between May 2017 and March 2018, were randomly assigned into an ORi and a control group. In the ORi group, FiO2 was reduced if ORi was > 0. In the control group, the FiO2 level was adjusted according to SpO2. Clinicians recorded blood gas results, episodes of atelectasis, and the length of time spent on mechanical ventilation, for up to 28 days. The principal point of comparison was the proportion of ventilated days with hyperoxemia.

The researchers found that the percentage of days with hyperoxemia was significantly lower in the ORi group: median 14% [interquartile range 0-31%], vs. 29% [IQR 11-50%] in the control group, p=0.005. Average daily PaO2 and FiO2 values were not significantly different between the two groups, suggesting that FiO2 was not systematically lowered in the ORi group. The average number of days without ventilation and median time spent in the ICU were also not significantly different.

The researchers concluded that the use of ORi may help clinicians reduce the percentage of days with hyperoxemia, that analysis of the full group of patients may allow assessment of its effect on the occurrence of atelectasis, and that additional studies may be useful in evaluating the impact of this monitoring on the morbidity and mortality of patients.

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

@MasimoInnovates || #Masimo

Reference
1. Brochant A, Dupre P, Gaillard T, Lemarie P, Gergaud S, and Lasocki S. ORi pour moins d'hyperoxie en reanimation. Proceedings from SFAR 2018, Paris, France. #R244.

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 9 of the top 10 hospitals listed in the 2018-19 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 http://www.masimo.com/evidence/featured-studies/feature/.

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 of the rainbow Acoustic Monitoring® RAS-45 Sensor for Infant and Neonatal Patients

Irvine, California – September 10, 2018 – Masimo (NASDAQ: MASI) announced today FDA clearance of RAS-45, an acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM®), for infant and neonatal patients. RAM could previously be used to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. With clearance of the RAS-45 sensor for infant and neonatal patients, acoustic respiration rate measurement is now, for the first time, possible for patients of all sizes, including neonates, in the United States.

Masimo Root with Radical-7, RRa, and the RAS-45 Infant/Neonatal Sensor
Masimo Root® with Radical-7®, RRa®, and the RAS-45 Infant/Neonatal Sensor

RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, the RAS-45 and RAS-125c, applied to the patient's neck area or, for infant and neonatal patients under 10 kg, the chest. 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 an acoustic respiration waveform, a visualization of the vibrations caused by the patient's airflow. The acoustic sensor also allows clinicians to listen to the sound of a patient's breathing, whether at the bedside, through a point-of-care device like the Radical-7® Pulse CO-Oximeter®, or remotely, from a Patient SafetyNet™ view station.

The RAS-45 sensor for infant and neonatal patients offers multiple benefits of particular importance for successfully monitoring these youngest and most fragile patients. With the clearance for newborns and neonates, RRa's accuracy range has been expanded up to 120 breaths per minute, while still providing accuracy of ± 1 breath per minute, facilitating accurate measurement of the higher respiratory rates common in this population. The sensor itself is significantly smaller than the RAS-125c sensor, and in fact with a diameter of approximately 2.2 cm without adhesive is only slightly larger than a nickel. Similarly, it weighs so little, 13 grams, that its presence may be barely noticeable, and features an adhesive that is transparent, light, and flexible. The size, weight, and adhesive advantages make it particularly suitable for the smaller stature and delicate skin of infants and neonates.

RRa has been shown not only to be accurate1,2 and reliable1, but also easy-to-use1, easy-to-tolerate1,3, and 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 capnography cannula, while only one removed the RAM 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 impedance pneumography.2

Joe Kiani, Founder and CEO of Masimo, commented, "From the beginning, we have focused our R&D on neonates and children for many reasons, including our belief that helping clinicians care for children will provide more benefit to society. RAM harnesses the power of our breakthrough signal processing and sensor technology and applies it to a measurement that has either been unreliable or difficult to use, respiration measurement, the third vital sign."

RAM is available on most rainbow SET™-ready platforms. 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.4,5

@MasimoInnovates || #Masimo

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

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 9 of the top 10 hospitals listed in the 2018-19 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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

 

New Study Compares Two Methods of Guiding Goal-Directed Fluid Therapy, Noninvasive Masimo PVi® and Invasive Esophageal Doppler

Neuchatel, Switzerland – September 5, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a study recently published in BMC Anesthesiology in which researchers at University Hospital Linkping, Sweden compared the performance of goal-directed fluid therapy (GDFT) using invasive esophageal Doppler to GDFT using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing major abdominal surgery.1

Noting the value of GDFT in aiming to determine "the optimal amount of fluid for an individual patient," Dr. Hans Bahlmann and colleagues sought to compare the effects of two methods of GDFT, stroke volume optimization guided by invasive esophageal Doppler (control group) and fluid optimization guided by noninvasive PVi (intervention group), on patients who were scheduled for open abdominal surgery lasting two or more hours. The effects compared were incidence of complications and length of hospital stay.

The researchers collected data from 146 patients who had surgery between November 2011 and January 2015, who were randomly divided into the two groups. In the intervention group, PVi was noninvasively and continuously measured with a Masimo Radical-7® Pulse CO-Oximeter® with software version 7.8.0.1 and SET® sensors.  After an initial fluid bolus (given to all patients irrespective of PVi value), a fluid bolus was given if PVi was ≥ 10%, repeated at 5 minute intervals until PVi fell below 10% or did not decrease at all. In the control group, esophageal Doppler measurements were performed using a Deltex Medical CardioQ apparatus.  After an initial fluid bolus, Doppler measurement was performed after 5 minutes and fluid boluses were repeated until stroke volume did not increase by 10%, in accordance with published protocols.

Observers blinded to each patient's group assessed complications for 30 postoperative days using a pre-specified list of complications, as well as length of hospital stay. The researchers found that noninvasive PVi and invasive Doppler performed with no statistical difference, with similar incidences of complications and lengths of stay between the two groups. In the intervention/PVi group, there were 64 complications (corresponding to 51% of patients), with a median length of stay of 8.0 days (interquartile range [IQR] 8.0 days). In the control/Doppler group, there were 70 complications (corresponding to 49% of patients), with a median length of stay of 8.0 days (IQR 9.5).

The researchers concluded, "No difference in clinical outcome, as defined by number of postoperative complications, and length of hospital stay, was found when goal directed fluid therapy was applied using PVI as an alternative to esophageal Doppler. PVI appears to be an acceptable alternative to esophageal Doppler for goal directed fluid therapy during major open abdominal surgery."

In discussing other PVi-related clinical studies, the researchers also noted that "Based on these reports and our findings, a clinician wishing to pursue GDFT can choose PVI over esophageal Doppler in the large majority of patients undergoing major open abdominal surgery. PVI, in contrast to esophageal Doppler, is not sensitive to interference from diathermy and does not require frequent access to the patient's head for probe repositioning. Also, PVI can be measured without single-use equipment avoiding the cost for single-use esophageal probes (USD 130 in our setting). However, as illustrated by the request for Doppler data in two PVI patients, the clinician might still want to have access to a reliable method for measuring intraoperative cardiac output to increase the amount of hemodynamic information during unusually complex situations or in cases of known vascular and/or myocardial dysfunction."

As a study limitation, the researchers noted the absence of a control group with neither PVi nor Doppler guiding fluid therapy, and therefore "it is not possible to tell whether PVi and Doppler both result in similar improvements in outcome, or whether neither method improves outcome when compared to treatment without GDFT." They also noted that because of determining sample size using a 10% difference in the number of complications at 30 days, "the study was not powered to detect smaller albeit still significant differences in postoperative outcome."

PVi has not been cleared by the FDA to assess fluid responsiveness.

@MasimoInnovates || #Masimo

Reference
1. Bahlmann H, Hahn R, and Nilsson L. Pleth variability index or stroke volume optimization during open abdominal surgery: a randomized controlled trial. BMC Anesthesiology. (2018) 18:115. https://doi.org/10.1186/s12871-018-0579-4.

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 9 of the top 10 hospitals listed in the 2018-19 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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

 

New Study Evaluates the Ability of Masimo ORi™ to Reflect Oxygenation During Moderate Hyperoxia

Neuchatel, Switzerland – August 27, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a study recently published in Anesthesia & Analgesia in which researchers at the University of Groningen, the Netherlands and Ghent University, Belgium investigated the ability of Masimo ORi™ (Oxygen Reserve Index) to show trends in oxygenation in the moderate hyperoxic region (partial pressure of oxygen in arterial blood [PaO2] in the range of 100 to 200 mmHg).1 ORi is available outside the U.S. and is intended as a noninvasive, relative indicator of a patient's oxygen reserve during moderate hyperoxia. ORi can be trended and has optional alarms to notify clinicians of changes in oxygenation.

Masimo Root with Radical-7 and ORi

Masimo Root® with Radical-7® and ORi™

Noting that monitoring oxygenation using pulse oximetry alone "gives little information on PaO2" during conditions of normoxia and hyperoxia, Dr. Jaap Jan Vos and colleagues sought to evaluate the correlation of ORi to PaO2 during moderate hyperoxia. They collected data from 20 healthy adult volunteers, who breathed a series of standardized oxygen concentrations ranging from mildly hypoxic (inspired oxygen = 14%) to extremely hyperoxic (inspired oxygen = 100%). ORi and SpO2 were noninvasively and continuously measured by sensors on both the second and fourth fingers and displayed on a Masimo Radical-7® Pulse CO-Oximeter®. At baseline and at each induced oxygenation stage, arterial blood samples were taken for blood gas analysis and PaO2 was measured invasively using a Siemens Rapidpoint 405 CO-Oximeter.

The researchers collected 1090 paired data points of simultaneous ORi and PaO2 values. In the "ORi-sensitive" range of 100-200 mmHg, the mean ORi value was 0.16, with associated oxygen saturation (SpO2) values of ≥ 97% at all points. Correlation between ORi and PaO2 was positive at all points (p < 0.0001), with R values of 0.78, 0.83, and 0.84 for sensor 1, sensor 2, and mean of both sensors, respectively. To assess ORi's trending ability, the researchers used a 4-quadrant plot and calculated that ORi trending of PaO2 within the range of 100-200 mmHg had a concordance rate of 94%.

The researchers concluded, "In this prospective volunteer validation study, a strong and positive correlation between PaO2 and ORi was found, together with a good trending ability. Based on these data, the future use of ORi as a continuous noninvasive monitoring tool for assessing oxygenation status in patients receiving supplemental oxygen might be supported." They also noted that "in healthy volunteers, ORi provides reasonable trending information of PaO2 around the moderate hyperoxic range of PaO2 for which its use is intended. Also, changes in PaO2 are well reflected by changes in ORi, with good concordance. The trend in ORi can be used to track changes in PaO2 levels in the moderate hyperoxic region, and absolute values should not be interpreted for PaO2 levels."

The researchers noted several limitations of the study, including that "additional studies are required to confirm these findings in a clinical setting" and that the influence of factors such as patient comorbidity and clinical circumstances requires further research. In addition, the researchers observed differences between the absolute values of simultaneously measured ORi values from sensors placed at different sites on the subject, which may require further studies in order to clinically rely on absolute ORi values as a direct measure of oxygen reserve, especially in situations where accurate oxygenation assessment may be necessary.

Study co-author Professor Thomas Scheeren commented, "ORi fills a gap in the monitoring of patients receiving supplemental oxygen by noninvasively and continuously trending the course of arterial oxygen tension. It may help to better titrate oxygen therapy to avoid both hypoxia and unintended hyperoxia."

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

@MasimoInnovates || #Masimo

Reference
1. Vos JJ, Willems CH, Van Amsterdam K, van den Berg J, Spanjersberg R, Struys MMRF, and Scheeren TW. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 22 Aug 2018. DOI: 10.1213/ANE.0000000000003706.

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 Investigates the Utility of Home Monitoring Using Masimo SET® Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies

Southampton, United Kingdom – August 13, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers investigated whether home pulse oximetry monitoring might be a useful initial screening method of determining which children with down syndrome (DS) – who are at high risk of obstructive sleep apnea (OSA) – be recommended to undergo multichannel sleep studies to diagnose the condition. The home monitoring was conducted using Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.1

Masimo Radical-7

Masimo Radical-7® Pulse CO-Oximeter®

Noting that OSA "can only be reliably diagnosed using multichannel sleep studies, which are expensive, demanding for families and only available in specialist centres," Dr. Hill and colleagues at the University of Southampton and Southampton Children's Hospital sought to determine whether home pulse oximetry monitoring could identify children at high risk of OSA, and in particular which parameters could most sensitively detect this risk, as an initial screening step. To that end, they studied 161 children with DS, aged 0.5 to 6 years, of whom 25 were separately diagnosed with OSA. The patients were monitored overnight using Masimo Radical-7® Pulse CO-Oximeters®, with pulse oximetry sensors placed on the great toe. Recorded measurements included: total artifact-free time analyzed, mean oxygen saturation (SpO2), minimum SpO2, 3% oxyhemoglobin desaturation index (ODI), delta 12s index (the absolute difference between successive 12 second interval recordings, a measure of baseline SpO2 variability) and the number of minutes per hour that SpO2 was below 90%.

Receiver operating curves (ROC) and area under the curve (AUC) statistics were calculated to determine which measurements, alone and in combination, best predicted OSA status. During data analysis, researchers were blinded to which children had separately received a diagnosis of OSA. The researchers found that "The greatest AUC was achieved by the delta 12s index. At a threshold of >0.555, this identified 23/25 (sensitivity 92%) OSA cases and 89/136 true negatives (specificity 65%). The same sensitivity was achieved for 3% ODI with marginally lower specificity of 63% (86/136 true negatives)." The combined model (delta 12s index, 3% ODI, mean and minimum SpO2) detected all true positives (100% sensitivity) but with lower specificity (53%). This result would lead 60% of the sample population (12 true positives and 18 false negatives) to confirmatory multichannel studies.

The researchers concluded that "Universal screening for OSA in children with DS using simple pulse oximetry parameters could halve the number of children requiring specialist multichannel studies. Pulse oximetry is widely available, well tolerated, readily acquired in the home and its adoption could reduce the burden on health services and families alike."

The researchers noted that "Our findings specifically apply to parameters generated by Masimo oximeters and cannot be generalised to other devices. Masimo technology extracts motion artefact, this is important in children with DS who are restless sleepers." They also noted that "the use of a retrospective clinical dataset, with anonymous data shared for this analysis, limits our information on the wider sampling frame, demographic and clinical characteristics of these children."

Masimo pulse oximetry is not cleared in the United States to screen children with Down syndrome for risk of obstructive sleep apnea.

@MasimoInnovates || #Masimo

Reference
1. Hill C, Elphick H, Farquhar M, Gringras P, Pickering R, Kingshott R, Martin J, Reynolds J, Joyce A, Gavlak J, and Evans H. Home oximetry to screen for obstructive sleep apnoea in Down syndrome. Arch Dis Child. doi:10.1136/archdischild-2017-314409.

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.

 

H Michael Cohen Joins Masimo's Board of Directors

IRVINE, Calif – August 02, 2018 – Masimo (NASDAQ: MASI), a global medical technology developer and manufacturer of innovative noninvasive patient monitoring technologies, announced today that H Michael Cohen, former Vice Chairman of Healthcare Investment Banking at Deutsche Bank Securities, has been elected to Masimo's Board of Directors.

Mr. Cohen has almost 30 years of experience in the healthcare industry. Over the past 19 years, he has held various roles at Deutsche Bank, including Global Head, Healthcare Investment Banking and most recently Vice Chairman, Healthcare Investment Banking. Prior to joining Deutsche Bank, Mr. Cohen worked at SG Cowen, Union Bank of Switzerland, and Booz Allen Hamilton. Mr. Cohen began his career in healthcare at Hambrecht & Quist, where he was a member of the equity research team covering biotechnology, medical device, and diagnostic companies. He received his B.A. in Economics from the University of Vermont and his M.B.A. from Columbia University.

Joe Kiani, Founder, Chairman and CEO of Masimo, said, "We're thrilled to welcome Michael to our Board of Directors. With his vast experience in healthcare investment banking and deep understanding of the medical technology industry and the complexities of global healthcare, he'll be an excellent addition. We look forward to benefiting from his expertise and insight as Masimo continues to grow."

"I'm honored to join Masimo's Board," said Mr. Cohen. "It's been a privilege to observe Masimo grow from its humble beginning in 1989 into the global leader in noninvasive monitoring it has become today, and I'm excited to help shape the next stage of its journey while driving long-term value for Masimo and its shareholders."

@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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

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


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 Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorectal Surgery

IIzmit, Turkey – July 16, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Kocaeli University in Turkey compared the performance of conventional fluid management (CFM) to goal-directed fluid management (GDFM) using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing elective colorectal surgery. The primary points of comparison were the amount of crystalloids administered and blood lactate and serum creatinine levels during the intraoperative period.1



Masimo Radical-7® with PVi®, SpHb®, and RD rainbow SET™ Sensor (Photo: Business Wire)

In the study, Dr. Cesur and colleagues, noting the importance of intraoperative fluid management in terms of postoperative organ perfusion and complications, sought to compare the effects of CFM (guided by clinical assessment and heart rate, arterial blood pressure, and invasively measured central venous pressure) with GDFM (guided by clinical assessment and noninvasive Masimo PVi monitoring). They enrolled 70 ASA I-II adult patients undergoing elective colorectal tumor surgery, who were divided randomly into CFM and GDFM groups. PVi was measured using a Masimo Radical-7® Pulse CO-Oximeter® with software version 7.0.3.3 and SET® sensors. In the CFM group, an NaCl solution was administered at the rate of 4-8 ml/kg/h; when mean arterial pressure (MAP) fell below 65 mmHg or 30% baseline MAP, the speed of infusion was increased, colloid was initiated, and ephedrine was administered. In the GDFM group, the same solution was administered at the rate of 2 ml/kg/h; if PVi rose above 13% for more than 5 minutes, colloid and then ephedrine were administered. Treatments in both groups were continued until values were restored to each protocol's pre-treatment threshold.

The researchers found that intraoperative crystalloid administration, urine output, and end-surgery fluid balance were significantly lower in the GDFM (PVi) group:

Characteristic Median value (25-75 percentile values): CFM group Median value (25-75 percentile values): GDFM (PVi) group P-value
Intraoperative crystalloid administration 1946 ml (1500-2500 ml) 900 ml (800-1060 ml) <0.001
Urine output 400 ml (250-600 ml) 300 ml (200-400 ml) 0.018
End-surgery fluid balance 1400 ml (960-2250 ml) 620 ml (410-1000 ml) <0.001

Durations of anesthesia and of surgery, as well as the amounts of intraoperative bleeding and administered colloid, were similar. The length of hospital stay was also found to be similar between the two groups.

The researchers noted that a limitation of the study was that they chose the number of subjects based on the needs of their primary objective, the comparison of intraoperative fluid volume between the two protocols, so they may not have evaluated enough subjects to effectively compare secondary outcomes such as length of stay: "We determined the primary goal of this study as the amount of intraoperative fluid volume and established 35 patients were needed for each group; if postoperative complications, the length of hospital stay[, were] determined as the primary goal, perhaps our numbers [in] each group [w]ould be different."

@MasimoInnovates || #Masimo

References
1. Cesur S, Cardakozu T, Alparslan K, Turkyilmaz N, and Yavuz O. Comparison of conventional fluid management with PVI-based goal-directed fluid management in elective colorectal surgery. J Clin Mon. 14 June 2018. https://doi.org/10.1007/s10877-018-0163-y

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 http://www.masimo.com/evidence/featured-studies/feature/.

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 Vital Signs Check Application for the Root® Patient Monitoring and Connectivity Platform

Irvine, California – July 9, 2018 – Masimo (NASDAQ: MASI) announced today the worldwide release of the Vital Signs Check Application, an integrated patient data collection and workflow application for the Masimo Root® patient monitoring and connectivity platform. Vital Signs Check, available for new and existing Root customers through a software upgrade, augments Root's versatility by helping to automate hospital vital signs testing workflows.

Masimo Root Vital Signs Check

Masimo Root® Vital Signs Check

Root is a powerful, expandable platform that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions – in a single, clinician-centric hub. Root's plug-and-play expansion capabilities allow clinicians to simplify patient monitoring by bringing together advanced rainbow SET™ Pulse CO-Oximetry, brain function monitoring, regional oximetry, capnography, and vital signs measurements on an easy-to-interpret, customizable display, empowering clinicians with important information for making patient assessments.

Root Vital Signs Check allows clinicians to streamline vital signs measurement workflows and optimize patient data management through:

  • Automated patient association, with the ability to quickly associate clinicians with their measurement sessions and patients with their data using barcode scanning or a drop-down menu that pulls data from a hospital's HL7 Admit Discharge Transfer (ADT) system.
  • Centralized data collection using a single device. Root, with the use of its optional roll stand, serves as a convenient, mobile data collection point for a variety of integrated measurements, including oxygen saturation (SpO2), pulse rate, respiration rate, noninvasive hemoglobin (SpHb®), and noninvasive blood pressure and temperature (including, in the U.S., non-contact thermometry via the newly announced TIR-1™). Clinicians can also enter up to 30 additional measurements for immediate documentation and validation at the patient's bedside, configured for each care area's protocols.
  • Early Warning Scores. Configurable early warning scores (EWS) can be calculated using up to 14 Root-measured and manually-entered contributors, as determined by hospital protocol.
  • Immediate electronic charting at the bedside, with the ability to send complete, comprehensive data to the hospital electronic medical record (EMR) with the touch of a button. If a network connection is interrupted or only available at an access point, Root can store up to 1,000 sessions and automatically push all data to the EMR once network access becomes available, saving time and minimizing the need for manual documentation. Local storage, coupled with unique patient identifiers, also allows clinicians to trend and review progress over time from the bedside, which may help to identify patterns of deterioration.

Joe Kiani, Founder and CEO of Masimo, said, "From the operating room to the emergency room, from the ICU to the med-surg unit, Root is streamlining care, simplifying access to critical data, and improving hospital workflows, all so that clinicians can stay focused on their patients. With the Vital Signs Check app, Root's utility is further enhanced, taking an important aspect of hospital care – the repetitive, data-and-labor-intensive measurement of patient vitals – that can benefit greatly from automation and bringing it in line with the best that modern technology offers."

@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 http://www.masimo.com/evidence/featured-studies/feature/.

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 Investigates the Utility of Masimo ORi™ (Oxygen Reserve Index) in Providing Early Detection of Blood Oxygenation Decrease During One-Lung Ventilation

Morioka, Japan – July 2, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a study in which researchers evaluated the ability of Masimo ORi™ (Oxygen Reserve Index) to detect declining blood oxygenation prior to standard oxygen saturation (SpO2) monitoring in patients undergoing elective thoracic surgery requiring one-lung ventilation (OLV).1

Masimo Root with Radical-7 and ORi

Masimo Root® with Radical-7® and ORi™

ORi is a noninvasive, 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 study, Dr. Koishi and colleagues at Iwate Medical University in Morioka, Japan sought to evaluate whether ORi could serve as an early warning of desaturation in patients undergoing OLV, as such patients are often prone to hypoxemia. To this end, they assessed whether ORi decreased earlier than SpO2 during OLV, and evaluated how well ORi correlated with an invasive PaO2 measurement. ORi and SpO2 were measured every 2 seconds using a Masimo Root® with Radical-7® Pulse CO-Oximeter® and rainbow® sensors (revision L). The anesthesiologist was blinded to the ORi values. For data analysis, the researchers defined the start of the decrease in ORi as when its value fell below 0.05 less than its highest value after OLV began, and the start of the decrease in SpO2 as when it was 1% less than the maximum SpO2 value. PaO2 was calculated as part of blood gas analysis and performed every 3 minutes during OLV, resulting in 101 pairs of measurements.

The researchers found that from the start of OLV, ORi started decreasing significantly sooner than SpO2, a mean of 171 seconds vs. a mean of 372 seconds, p<0.01 (standard deviation of 102 and 231 seconds, respectively). They also found "a significant, strong correlation" between ORi and PaO2: r2=0.671, p<0.01.

The researchers concluded, "ORi decreased significantly earlier than SpO2 during OLV, suggesting that monitoring ORi might allow earlier detection of a deterioration of blood oxygenation than monitoring SpO2 alone, contributing to a reduction in the patient's risk of exposure to complications from OLV. However, further studies in different clinical and experimental settings are needed to evaluate the superiority of the ORi over SpO2."

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

@MasimoInnovates || #Masimo

Reference
1. Koishi W, Kumagai M, Ogawa S, Hongo S, and Suzuki K. Monitoring the Oxygen Reserve Index can contribute to the early detection of deterioration in blood oxygenation during one-lung ventilation. Minerva Anestesiologica. 14 May 2018. DOI: 10.23736/S0375-9393.18.12622-8.

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. 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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

 

United Arab Emirates Ministry of Health & Prevention Adopts National CCHD Newborn Screening Program Using Masimo Rad-97™ Pulse CO-Oximeters® with Eve™

Dubai, United Arab Emirates – June 26, 2018 – Masimo (NASDAQ: MASI) announced today that the United Arab Emirates (UAE) Ministry of Health & Prevention (MOHAP) is adopting a national screening protocol for critical congenital heart disease (CCHD) for all newborns. As part of the program launch, the MOHAP is equipping 9 hospitals across 5 emirates, serving 50% of the UAE population, with Masimo Rad-97™ Pulse CO-Oximeters® with Eve™ CCHD Newborn Screening Application. Newborns delivered at these hospitals will now be screened for CCHD using Eve – the first large-scale installation of Eve on Rad-97, which received CE marking earlier this year.

Masimo Rad-97 with Eve

Masimo Rad-97™ with Eve™

CCHD affects approximately 2.5 to 3 newborns per 1000 live births1 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.2 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.3 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.4

Eve, also available on the Radical-7® Pulse CO-Oximeter, combines the power of Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry with an automated pre- to post-ductal synchronization algorithm designed to reduce calculation errors. In addition, Eve simplifies the CCHD screening process by providing visual instructions, animations, 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.5

Masimo worked closely with the UAE to implement the MOHAP program, including onsite training for doctors, nurses, and midwives at each hospital. H.E. Dr. Yousif Al Serkal, Assistant Undersecretary for the Hospitals Sector, emphasized the Ministry's strategy of "providing comprehensive and innovative health services in accordance with the highest standards of excellence, professionalism, and leadership in the health sector. The goal of the 'Newborn Critical Congenital Heart Screening Program' is to ensure that all UAE newborns are screened, and all affected infants receive appropriate confirmatory testing, counseling, and treatment to prevent complications and reduce mortality." He noted that the program has a comprehensive database and e-system for the registration of all screening test results, as well as helping to control quality and track performance through periodic reporting. Dr. Kalthoom Al Balooshi, Director of the Hospitals Department, explained that "the screening initiative will be implemented in nine main hospitals, which includes screening with pulse oximetry, a CCHD screening database, integrated EMR solutions, and awareness programs for physicians, nurses, and parents."

Jon Coleman, President of Worldwide Sales, Professional Services, and Medical Affairs for Masimo, said, "We are honored that the UAE chose Masimo to help implement this vital newborn screening process for their citizens. Masimo SET® performance and accuracy have helped to usher in reliable and cost-effective CCHD screening, as shown in the multiple studies concluding that SET® pulse oximetry, combined with clinical assessment, significantly improved CCHD screening sensitivity. We believe that Masimo SET® pulse oximetry and the Eve CCHD Screening App make for a compelling combination, and hope that more institutions and governments around the world will recognize the importance of helping their youngest patients get a great start in life."

Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion SET® pulse oximetry and upgradeable rainbow® technology, in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities. In addition to Eve, Rad-97 is also available in configurations with integrated noninvasive blood pressure measurement and integrated NomoLine™ capnography.

@MasimoInnovates || #Masimo

References
1. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
2. 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygiene, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7.
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;Jan 8;338.
4. 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.
5. 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.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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 and PositiveID Announce the U.S. Release of TIR-1™

Irvine, California and Delray Beach, Florida – June 18, 2018 - Masimo (NASDAQ: MASI) and Thermomedics, a PositiveID (OTCQB: PSID) company, announced today the debut and U.S. market release of TIR-1™, a non-contact Bluetooth®-enabled thermometer that integrates seamlessly with the Masimo Root® patient monitoring and connectivity platform.

Masimo TIR-1

Masimo TIR-1™

TIR-1 is an easy-to-use, clinical-grade infrared thermometer that provides forehead temperature measurements across all patient populations. As a non-contact device, the thermometer reduces the possibility of cross-contamination and eliminates the need to purchase additional disposables such as probe covers, reducing cost and waste. Its simple, one-button operation delivers patient temperature results in seconds, reducing the time needed to take temperature measurements compared to traditional methods. Bluetooth connectivity, available exclusively in the customized thermometer developed by Thermomedics for Masimo, enables wireless data transfer to a connected Root monitor, automating efficient integration of an important patient vital sign into bedside devices, including early warning scores, and from there to hospital EMRs via Masimo Patient SafetyNet™* or Iris Gateway™.

Masimo Root is a powerful, expandable patient monitoring and connectivity hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions – in a single, clinician-centric platform. Root's plug-and-play expansion capabilities allow clinicians to centralize patient monitoring by bringing together advanced rainbow SET™ Pulse CO-Oximetry, brain function monitoring, regional oximetry, capnography, and vital signs measurements – now including non-contact thermometry – on an easy-to-interpret, customizable display, empowering clinicians with more information for making patient assessments.

Joe Kiani, Founder and CEO of Masimo, said, "TIR-1 is a great example of the powerful expandability and versatility of the Root platform, and of our commitment to improving patient care through streamlined and automated workflows. This thermometer makes it easy to efficiently take the temperatures of multiple patients without having to manually record data. We're delighted to have partnered with Thermomedics to develop an additional, easy-to-use thermometry option for Root customers."

William J. Caragol, Chairman and CEO of PositiveID, said, "Our team worked diligently to develop the TIR-1, the first Bluetooth-wireless non-contact thermometer to be paired with a vital signs monitoring system. We are very proud to bring this product to market with a world-class company like Masimo and introduce non-contact thermometry to the Root platform."

@MasimoInnovates || #Masimo

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

About Thermomedics/PositiveID
About Thermomedics/PositiveID Thermomedics, Inc. designs, develops and markets medical diagnostic equipment for professional healthcare providers. Our products are specifically designed for use in a wide range of medical settings, delivering nearly instantaneous diagnostic information. Our goal was simple from the start. We wanted to build the best equipment and bring the most cutting edge technology to frontline medical professionals. Thermomedics, Inc. is a wholly owned subsidiary of PositiveID Corporation™ (OTCQB: PSID), a life sciences tools and diagnostics company. PositiveID specializes in the development of microfluidic systems in order to detect biological threats and outbreaks, whether airborne, in a healthcare setting, or at the point of need through its ExcitePCR subsidiary. For more information on PositiveID, please visit www.psidcorp.com, or connect with PositiveID on Twitter, Facebook or LinkedIn.

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.

Allison Tomek
Thermomedics/PositiveID
Phone: (561) 805-8044
Email: atomek@psidcorp.com

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 Utility of Masimo SedLine® Patient State Index in Monitoring Anesthesia Depth of Patients with Healthy and Cirrhotic Livers

Copenhagen, Denmark – June 11, 2018 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at Euroanaesthesia 2018 in which researchers compared Masimo Patient State Index (PSi), a processed EEG parameter provided by SedLine® brain function monitoring (in this study, first generation SedLine), to Medtronic Bispectral Index (BIS™) in monitoring the depth of anesthesia of two groups of patients: healthy volunteers undergoing hepatotomy for liver donation and cirrhotic patients undergoing liver resection. The researchers found "excellent" agreement between the two methods as well as similar sevoflurane consumption, and found that PSi 1.0 was less affected by electrocautery.1

Masimo MightySat
Masimo Root® with SedLine® PSi and O3® Regional Oximetry

In the study, Dr. Yassen and colleagues at Menoufia University in Shibin El Kom, Egypt sought to test agreement between two brain function monitoring indices, Masimo PSi and Medtronic BIS. They monitored 60 patients in 4 sub-groups: with healthy livers undergoing hepatotomy (15 PSi, 15 BIS) and with cirrhotic livers undergoing resection (15 PSi, 15 BIS). Sensors for both technologies were simultaneously applied and anesthetists monitoring PSi were blinded to BIS results and vice versa. To measure the level of interference from electrocautery on each index, the researchers noted whether BIS and PSi values were present (displayed) or absent each time the electrocautery unit was activated.

The researchers found "An excellent degree of reliability between PSi and BIS at all measuring points." With 804 data pairs total, they calculated an overall intra-class correlation of 0.92 (95% confidence interval of 0.91-0.93, p<0.001). Using Bland-Altman analysis, they calculated overall mean bias difference of 2.19 (95% confidence interval of 1.40-2.98, p<0.0001). PSi-guided and BIS-guided sevoflurane consumption were similar: 65.67ml±31.60ml and 68.47ml±27.63ml respectively, p=0.983.

The researchers found the following rates of incidence of electrocautery interference:

Diathermy interference? PSi 1.0 BIS Test of significance
No 96.67% 31.67% Z=7.4246 (p≤0.001)
Yes 3.33% 68.33%

The researchers concluded, "Agreement between PSi and BIS during surgery is excellent among patients with healthy or cirrhotic livers. Both can be used to monitor trends of anaesthesia depth changes and equally consumed similar sevoflurane volumes. However PSi allowed for continuous monitoring without interruptions from electrocautery."

SedLine brain function monitoring 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, now available worldwide, features an enhanced PSi with less susceptibility to EMG interference and improved performance in low power EEG cases, as well as an enhanced Multitaper Density Spectral Array (DSA).

@MasimoInnovates || #Masimo

Reference
1. Yassen K, Elsheikh M, Helal S, Badawy E, and Metwally A. Patient State Index versus Bispectral Index in cirrhotic patients and non-cirrhotics undergoing hepatic resection: A controlled randomized study. Proceedings from Euroanaesthesia 2018, Copenhagen, Denmark. #1167.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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 Investigates the Utility of Continuous Noninvasive Hemoglobin Measurement with Masimo SpHb® for Reflecting Real-time Iatrogenic Hemodilution During Incremental Fluid Administration

Copenhagen, Denmark – June 4, 2018 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at Euroanaesthesia 2018 in which researchers compared Masimo noninvasive and continuous hemoglobin (SpHb®) to intermittent and invasive lab hemoglobin (LabHb) in reflecting iatrogenic hemodilution during incremental fluid administration of patients undergoing major surgery.1

Masimo MightySat
Masimo Root® with Radical-7® and SpHb®

In the study, Dr. Azriel Perel, Dr. Serban Bubenek, and colleagues at the Emergency Institute for Cardiovascular Diseases in Bucharest examined the effects of incremental fluid loading on oxygen delivery and on LabHb and SpHb as markers of possible iatrogenic hemodilution, which can necessitate blood transfusions that might otherwise be avoided. 40 adult patients undergoing major gastrointestinal or vascular surgery were enrolled. Oxygen saturation (SpO2) and SpHb were continuously measured using a Masimo Radical-7® Pulse CO-Oximeter®. LabHb and partial pressure of oxygen (PaO2) were intermittently, invasively measured using an ABL800 Radiometer. Cardiac output (CO) and stroke volume (SV) were continuously, invasively measured using an Edwards Vigileo monitor. Oxygen delivery (DO2) was calculated as: CO*((Hb*1.38*SpO2)+PaO2*0.0031)). Parameter values were recorded after induction of anesthesia (T0), and 5 minutes after successive 250 ml colloid fluid challenges (FC) (T1, T2, and T3). Patients were given the second and third fluid challenges if at each stage SV increased by at least 10%.

All 40 patients received the first FC, 33 received the second, and 22 received the third. The researchers found that there was "a statistically significant decrease in mean SpHb and LabHb after each FC." For patients who received all 3 FCs, they noted that "SpHb and LabHb decreased significantly and similarly after each FC." After infusion of the full 750 ml, SpHb and LabHb decreased by 1.66±0.67 g/dL and 1.7±0.7 g/dL, respectively, a decrease in Hb values which "explains the observed decrease in the DO2."

The researchers concluded, "Fluid loading as part of goal-directed therapy may cause a paradoxical decrease in DO2 due to the development of iatrogenic hemodilution. The development of iatrogenic hemodilution is reflected by a real-time decrease in the SpHb trend, which is similar to the intermittent LabHb trend."

Dr. Azriel Perel commented, "In many studies on perioperative and septic patients, the patients who received more fluids seem to have received significantly more blood transfusions. The most probable reason for that is the development of acute dilutional anemia causing the hemoglobin value to decrease below the 'transfusion threshold.' This study clearly shows that fluid administration, given as part of the conventional perioperative goal-directed strategy aimed at maximizing the cardiac output, does indeed cause a significant acute decrease of the hemoglobin concentration, leading to a paradoxical decrease in oxygen delivery. This iatrogenic decrease in hemoglobin concentration may cause physicians to administer otherwise avoidable RBC transfusions. Our study also demonstrates that continuous monitoring of hemoglobin (SpHb) through Masimo Pulse CO-Oximetry sensors may detect the development of such iatrogenic hemodilution in real time."

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

References
1. Bubenek S, Valeanu L, Popescu M, Cacoveanu M, Tomescu D, and Perel A. Optimization of cardiac output by incremental fluid administration is associated with iatrogenic hemodilution and a paradoxical decrease in oxygen delivery. Proceedings from Euroanaesthesia 2018, Copenhagen, Denmark.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

 

Women's Tennis Association to Use Masimo MightySat™ Fingertip Pulse Oximeters to Advance Player Health and Performance

St. Petersburg, Florida and Irvine, California – May 21, 2018 – The Women's Tennis Association (WTA) and Masimo (NASDAQ: MASI) announced today that the WTA's Sport Sciences and Medicine (SS&M) team will immediately begin using Masimo MightySat™ as part of their mission to provide comprehensive care for athletes on the women's professional tennis circuit.

Masimo MightySat
Masimo MightySat™

MightySat is a fingertip pulse oximeter designed for general wellness and health applications including sports, fitness, and relaxation management. MightySat provides noninvasive measurements of oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), PVi® (studies show changes in PVi may indicate changes in hydration, breathing effort, perfusion, or other factors1-3) and RRp™ (respiration rate based on the plethysmographic waveform). MightySat features Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry. MightySat displays all noninvasive measurements in real time, and users can also display and track their data through the Masimo Personal Health app for iOS® and Android® compatible devices.

The WTA SS&M team's primary health care providers (PHCPs – licensed physical therapists and certified athletic trainers) will use MightySat at WTA tournament events to help support the general health, wellness, and fitness of elite women's tennis players. "We're fortunate to have this new technology in the training room and on the court at the WTA. This equipment will aid our PHCPs in assessing player health and allow them to better service the immediate needs of our athletes," said Kathleen Stroia, SVP SS&M and Transitions for the WTA.

Coco Vandeweghe

Coco Vandeweghe

"We have been encouraged by the feedback we have received from elite athletes and trainers about how MightySat helps them improve their health and performance. For example, they use Masimo's unique accuracy to decide on how hard to train," said Joe Kiani, Founder and CEO of Masimo. "We are excited to work with the WTA to help them use Masimo's breakthrough noninvasive technologies to make a meaningful difference in women's tennis. We have long been big fans of the sport and are excited to help these peak performing athletes reach even greater heights."

MightySat is intended for general wellness and health applications. For medical applications, Masimo offers MightySat Rx, which is available to medical professionals.

@MasimoPersonalHealth || #MightySat

References
1. Schooljans A et al. Pleth Variability Index Combined with Passive Leg Raising-Induced Pulse Pressure Variation to Detect Hypovolemia in Spontaneously Breathing Patients. Acta Anaesth Belg. 2010 (61), 147-150.
2. Mathews D et al. PVi Decreases Following a Fluid Bolus Administered in the PACU to Treat Hypotension. ASA 2014. A1124.
3. Perel A. Anesth Analg. 2014 Dec;119(6):1288-92.

About the WTA
The WTA is the global leader in women's professional sport with more than 2,500 players representing nearly 100 nations competing for a record $146 million in prize money. The 2018 WTA competitive season includes 54 events and four Grand Slams in 30 countries. In 2017, the WTA was watched around the world by a total TV audience of 500 million. The 2018 WTA competitive season concludes with the BNP Paribas WTA Finals Singapore presented by SC Global from October 21-28, 2018 and the Hengqin Life WTA Elite Trophy in Zhuhai, China from October 30-November 4, 2018. Further information on the WTA can be found at ww.wtatennis.com, facebook.com/WTA and twitter.com/WTA.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

Heather Bowler
WTA
Email: hbowler@wtatennis.com

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 Economic Impact and Utility of Continuous Noninvasive Hemoglobin Measurement with Masimo SpHb® in Reducing Unnecessary Blood Transfusions

Madrid, Spain – May 14, 2018 – Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers evaluated the utility of Masimo noninvasive and continuous hemoglobin (SpHb®) in reducing the number of unnecessary blood transfusions, thus reducing costs and improving quality of care.1

In the study, Dr. Ribed-Snchez and colleagues at HM Hospitales, ETSII-Universidad Nacional de Educaon a Distancia (UNED), and CEU San Pablo University in Spain compared the transfusion outcomes of two groups of patients undergoing hip trauma surgery: those whose hemoglobin levels were measured using traditional invasive blood draws and those whose levels were monitored continuously using Masimo SpHb. The researchers' goal was to determine whether there was a difference in the percentage of patients transfused and the number of units transfused per patient between the two groups. 115 control group patients had hemoglobin levels intermittently checked through invasive blood draws and laboratory analysis. 122 experimental group patients had hemoglobin levels monitored continuously with Masimo Radical-7® Pulse CO-Oximeters® with SpHb.

The researchers found a decrease in the percentage of patients receiving a transfusion from 48.7% in the control group to 45.1% in the experimental (SpHb) group, a 7.4% reduction. The number of units transfused per patient dropped from 1.322 to 1.156, a 12.56% decrease. Based on the average cost of a unit of blood in Spain and taking sensor cost into account, they calculated that on an annual and national level, the reduction could lead to an estimated savings of 1.756 million euros and 13,500 fewer units of blood transfused.

The researchers concluded, "Constant monitoring of the value of hemoglobin during surgeries with significant blood loss significantly reduces blood transfusions. Based on the reduction of transfusions by using this measurement technology, health facilities can significantly reduce their costs while improving quality of care."

Joe Kiani, Founder and CEO of Masimo, commented, "This is the fifth SpHb study showing a reduction in blood transfusion,1-5 which is not only expensive, but associated with mortality. In fact, all six of the clinical outcome studies on SpHb that we are aware of to date have been positive.6 In addition to blood transfusion reduction, three of the studies showed faster time to transfusion for patients who needed it."3,5,7

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

References
1. Ribed-Snchez B, Gonzlez-Gaya C, Varea-Daz S, Corbacho-Fabregat C, Prez-Otoyza J, and Belda-Iniesta C. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
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. Abstract #PR607.
5. Kamal A et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice during Abdominal Cancer Surgery. Open Journal of Anesthesiology, 6, 13-19. DOI: 10.4236/ojanes.2016.63003
6. Published clinical studies and abstracts on Masimo SpHb can be found at http://www.masimo.com/evidence/pulse-co-oximetry/sphb/.
7. 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. 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 http://www.masimo.com/evidence/featured-studies/feature/.

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 SET® Pulse Oximetry Helps Form Basis of Utah Senate Resolution on Postoperative Oxygen Saturation Home Monitoring for Patients Prescribed Opioids

Salt Lake City, Utah – May 7, 2018 – The Utah State Legislature and Governor Gary Herbert have recently signed into law the Concurrent Resolution on Deaths From Opioid-Induced Postoperative Respiratory Depression (SCR4). The resolution urges hospitals, clinicians, and researchers to examine and identify possible links between opioids and respiratory depression following surgery and encourages doctors to prescribe home monitoring for applicable patients, which may alert caregivers to low oxygen saturation (SpO2) and changes in breathing which can precede cardiac arrest and death. Pulse oximetry technology was used in the case studies that helped shape the legislation, providing lawmakers with compelling evidence of the need for postoperative home SpO2 monitoring of patients who are prescribed opiate painkillers.

SCR4 is commonly referred to as "Parker's Bill" in memory of Parker Stewart, a 21-year-old newlywed who tragically passed away in his sleep three days after tonsillectomy surgery, as a result of respiratory depression believed to be caused by opioid painkillers, of which he had taken only half the prescribed dose.

Researchers at Uintah Basin Medical Center and Intermountain Healthcare – Dr. Michael Catten, Shay Uresk, BSRT, RRT, SDS, and Kim Bennion, MsHS, RRT, CHC – have been investigating the utility of home pulse oximeter use on postoperative patients. Several case studies – using Masimo (NASDAQ: MASI) SET® Measure-through Motion and Low Perfusion™ pulse oximetry and rainbow Acoustic Monitoring® with RRa® – helped illustrate the benefits of postoperative monitoring for respiratory depression. Their work formed the basis for what became "Parker's Bill," SCR4.

"Even at normal doses, opioids can cause respiratory depression and death, and yet, the technology to monitor patients who are taking opioids is minimally expensive," commented Dr. Catten. "Home monitoring can save thousands – not a few, thousands – of lives a year. SCR4 passed unanimously through all committees and houses of the Utah legislature, without dissent, and I hope we'll be able to get other states onboard with similar home monitoring resolutions."

Moving forward and in accordance with the recommendations made in SCR4, clinicians at Uintah Basin Medical Center and Intermountain Healthcare are now prescribing home SpO2 monitoring using Masimo technology and devices, such as Rad-97™ Pulse CO-Oximeters®. Taking advantage of Rad-97's advanced connectivity capabilities when used together with Masimo Patient SafetyNet™*, a remote supplemental patient surveillance and clinician notification system, doctors are able to remotely monitor their at-home patients for signs of respiratory depression in real time, as an added precaution.

"This technology is a game changer," notes Dr. Catten. "The ability to observe and communicate with patients from afar is key. It's like having your own EMT by your side at home, watching to make sure you're okay after surgery. I'm so grateful to the engineers who work so hard to develop this technology, which has the potential to save so many lives."

In a landmark study at Dartmouth-Hitchcock Medical Center in New Hampshire, researchers found that continuous monitoring of adult post-surgical patients using Masimo SET® on Masimo bedside devices, in conjunction with Masimo Patient SafetyNet, resulted in a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU.1 Over five years, they achieved their goal of zero preventable deaths or brain damage due to opioids,2 and over ten years, they maintained a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increase in patient acuity and occupancy.3

Joe Kiani, Founder and CEO of Masimo, commented, "We are so happy to see Utah lawmakers recognize the suffering and death that unmonitored postoperative use of prescription painkillers can lead to – and the lives that continuous SET® pulse oximetry monitoring can help to save. Masimo is honored to have been part of the research and the solution surrounding passage of this historic legislation. We hope other states and countries will follow in addressing this important patient safety issue."

@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 http://www.masimo.com/evidence/featured-studies/feature/.

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 Reports First Quarter 2018 Financial Results

  • Total revenue, including royalty and other revenue was $213.0 million
  • Product revenue was $204.4 million
  • Shipments of noninvasive technology boards and monitors were 53,600
  • GAAP net income of $45.6 million, or $0.82 per diluted share. Non-GAAP net income of $41.9 million, or $0.75 per diluted share.

Irvine, California, May 2, 2018 – Masimo (NASDAQ: MASI) today announced its financial results for the first quarter ended March 31, 2018.

First Quarter 2018 Results:
First quarter 2018 total revenue, including royalty and other revenue, increased to $213.0 million. Product revenues for the first quarter of 2018 increased to $204.4 million.

The Company's worldwide direct product revenue, which accounted for 87.5% of total product revenue, increased to $178.9 million in the first quarter of 2018. OEM sales, which accounted for 12.5% of total product revenue, increased to $25.5 million in the first quarter of 2018.

GAAP net income for the first quarter of 2018 was $45.6 million, or $0.82 per diluted share.

Non-GAAP net income for the first quarter of 2018 was $41.9 million, or $0.75 per diluted share.

As a result of the strong performance in the first quarter, Masimo is raising its fiscal year 2018 product revenue guidance from $808 million to $818 million, its GAAP EPS guidance from $2.90 to $3.01 and its non-GAAP EPS guidance from $2.80 to $2.88.

During the first quarter of 2018, the Company shipped approximately 53,600 noninvasive technology boards and monitors.

As of March 31, 2018, total cash and cash equivalents were $369.5 million. During the first quarter of 2018, the Company repurchased approximately 0.2 million shares of common stock at a total cost of $16.5 million.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "We had another record quarter for product revenues and earnings, demonstrating once again the clinical and economic value of our innovative technologies for improving patient care. We achieved another strong quarter of shipments of our noninvasive monitoring technologies, at 53,600. Our positive outlook is visible in our higher guidance for sales and earnings in 2018 as we introduce important new products and gain new customers around the world."

2018 Financial Guidance
The Company provided the following updated estimates for its full year 2018 guidance:

1. Updated guidance provided May 2, 2018. Prior guidance provided February 27, 2018.

  • Total revenue, including royalty and other revenue, increasing to $846 million;
  • Product revenue increasing to $818 million;
  • GAAP diluted earnings per share increasing to $3.01; and
  • Non-GAAP diluted earnings per share increasing to $2.88

Impact of Adoption of New Revenue Accounting Standard:
During the first quarter of 2018, the Company adopted Financial Accounting Standards Board (FASB) Accounting Standards Update No. 2014-09, Revenue (Topic 606): Revenue from Contracts with Customers (ASU 2014-09). The new revenue recognition standard requires the Company to make numerous assumptions that are based upon historical trends and management judgment. These assumptions may change over time and may have a material impact on our revenue recognition, guidance and results of operations. In accordance with the full retrospective method of adoption, the Company has adjusted certain amounts previously reported in its unaudited condensed consolidated financial statements to comply with the new standard, as indicated by the notation, "As Adjusted". For additional information with respect to the impact of the adoption of this new accounting standard and reconciliations to the prior reported amounts, please reference Note 2 to our condensed consolidated financial statements that will be included in Part I, Item 1 of our Quarterly Report on Form 10-Q (Form 10-Q) for the quarter ended March 31, 2018 once filed with the Securities and Exchange Commission (SEC) and Exhibit 99.3 that was included in our Current Report on Form 8-K that was filed with the SEC today.

Supplementary Non-GAAP Financial Information
For additional non-GAAP financial details, please visit the Investor Relations section of the Company's website at www.masimo.com to access Supplementary Financial Information.

Non-GAAP Financial Measures

The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with U.S. GAAP. The non-GAAP financial measures presented exclude the items described below. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results. Furthermore, management also believes that these items are not indicative of the Company's on-going core operating performance. These non-GAAP financial measures have certain limitations in that they do not reflect all of the costs associated with the operations of the Company's business as determined in accordance with GAAP.

Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.

The Company has presented the following non-GAAP measures to assist investors in understanding the Company's core net operating results on an on-going basis: (i) non-GAAP net income, (ii) non-GAAP diluted earnings per share, (iii) non-GAAP gross profit, (iv) non-GAAP operating income and (v) adjusted EBITDA. These non-GAAP financial measures may also assist investors in making comparisons of the Company's core operating results with those of other companies. Management believes non-GAAP gross profit, non-GAAP operating income, non-GAAP net income, non-GAAP net income per diluted share and adjusted EBITDA are important measures in the evaluation of the Company's performance and uses these measures to better understand and evaluate our business.

The non-GAAP financial measures reflect adjustments for the following items, as well as the related income tax effects thereof:

Acquisition-related costs, including depreciation and amortization.

Depreciation and amortization related to the revaluation of assets and liabilities (primarily intangible assets, property, plant and equipment adjustments, inventory revaluation, lease liabilities, etc.) to fair value through purchase accounting related to value created by the seller prior to the acquisition rather than ongoing costs of operating our core business. As a result, we believe that exclusion of these costs in presenting non-GAAP financial measures provides management and investors a more effective means of evaluating historical performance and projected costs and the potential for realizing cost efficiencies within our core business. Depreciation and amortization related to the revaluation of acquisition related assets and liabilities will generally recur in future periods.

Litigation damages, awards and settlements.

In connection with litigation proceedings arising in the course of our business, we have recorded expenses as a defendant in such proceedings in the form of damages, as well as gains as a plaintiff in such proceedings in the form of litigation awards and settlement proceeds; most recently in connection with our November 2016 settlement agreement with Koninklijke Philips N.V. We believe that exclusion of these expenses and gains is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. In this regard, we note that these expenses and gains are generally unrelated to our core business and/or infrequent in nature.

Realized and unrealized gains or losses from foreign currency transactions.

We are exposed to foreign currency gains or losses on outstanding foreign currency denominated receivables and payables related to certain customer sales agreements, product costs and other operating expenses. As the Company does not actively hedge these currency exposures, changes in the underlying currency rates relative to the U.S. Dollar may result in realized and unrealized foreign currency gains and losses between the time these receivables and payables arise and the time that they are settled in cash. Since such realized and unrealized foreign currency gains and losses are the result of macro-economic factors and can vary significantly from one period to the next, we believe that exclusion of such realized and unrealized gains and losses are useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. Realized and unrealized foreign currency gains and losses are likely to recur in future periods.

Excess tax benefits from stock-based compensation.

Current authoritative accounting guidance requires that excess tax benefits or costs recognized on stock-based compensation expense be reflected in our provision for income taxes rather than paid-in capital. Since we cannot control or predict when stock option awards will be exercised or the price at which such awards will be exercised, the impact of such guidance can create significant volatility in our effective tax rate from one period to the next. We believe that exclusion of these excess tax benefits or costs is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. These excess tax benefits or costs will generally recur in future periods as long as we continue to issue equity awards to our employees.

Tax impacts that may not be representative of the ongoing results of our core operations.

The Tax Cuts and Jobs Act of 2017 (2017 Tax Act) was signed into law in December 2017, and became effective January 1, 2018. The 2017 Tax Act included a number of changes to existing U.S. federal tax law impacting businesses including, among other things, a permanent reduction in the corporate income tax rate from 35% to 21%, a one-time transition tax on the "deemed repatriation" of cumulative undistributed foreign earnings as of December 31, 2017 and changes in the prospective taxation of the foreign operations of U.S. multinational companies. We believe that exclusion of the tax charges related to the 2017 Tax Act is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. In this regard, we note that this tax charge is unrelated to our core business and non-recurring in nature.

First Quarter 2018 Actuals versus First Quarter 2017 Actuals:

Full Year 2017 Actuals versus Full Year 2018 Guidance:

1. Estimated effective tax rate of 22% applied to GAAP earnings and 25% applied to non-GAAP earnings.
2. As previously reported in February 2018, the 2017 Tax Act resulted in an unfavorable charge of $43.5 million in the fourth quarter of 2017. The amount recognized was a provisional estimate and subject to change, possibly materially, due to, among other things, refinements of the Company's calculations, changes in interpretations and assumptions the Company has made or additional guidance issued by the U.S. Treasury, Securities and Exchange Commission or Financial Accounting Standards Board.
3. Includes adjustments related to the full retrospective application of ASC 606 of $2.1 million, or $0.04 per diluted share.

1. Other (income)/expense consists primarily of interest (income)/expense and net foreign currency (gains)/losses.

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 4776719. After the live webcast, the call will be available on Masimo's website through May 30, 2018. In addition, a telephonic replay of the call will be available through May 9, 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 4776719.

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®), 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. Masimo is also taking an active leadership role in mobile health applications (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 http://www.masimo.com/evidence/featured-studies/feature/.

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.

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 O3® Regional Oximetry and SedLine® Brain Function Monitoring Power Two Investigations into Postoperative Delirium Presented at IARS

Chicago, Illinois – May 1, 2018 – Masimo (NASDAQ: MASI) announced today the use of Masimo technologies – O3® regional oximetry and SedLine® brain function monitoring – in two abstracts presented at the 2018 Annual Meeting of the International Anesthesia Research Society (IARS). Both studies investigated links between postoperative delirium and particular biomarkers.

O3 Regional Oximtery

In the first study1, Dr. Aymen Benkreira and colleagues at the Montreal Heart Institute sought to identify a possible link between venous congestion from right ventricular failure and postoperative delirium after cardiac surgery. As a proxy for venous congestion, they investigated whether there was a link between portal vein pulsatility (evaluated by point-of-care Doppler ultrasound) and postoperative delirium and associated features. In addition to daily cognitive and delirium evaluations for five consecutive days, the patients were evaluated for asterixis and bilateral cerebral oximetry values using Masimo O3. Of the 145 adult patients enrolled in the study, an abnormal cognitive status was identified in 36.9% of assessments and portal vein pulsatility in 42.3% of assessments. The researchers found significant associations between portal pulsatility and:

  • the development of cognitive dysfunction (odds ratio of 2.10, confidence interval of 1.25-3.53, p=0.005)
  • the development of asterixis (OR of 2.23, CI of 1.13-4.41, p=0.02)
  • a more than 15% decrease in cerebral oximetry values from pre-operative baseline (OR of 2.23, CI of 1.12-4.71, p=0.02).

The researchers concluded, "This data presents for the first time an association between an objective sign of portal hypertension of cardiac origin and delirium in cardiac surgery patients. This suggests that delirium may have a congestive origin in some patients."

In the second study2, Reine Ibala and colleagues at Massachusetts General Hospital sought to identify EEG biomarkers that could aid clinicians in preemptively identifying patients at risk for postoperative delirium. Such biomarkers – particular alpha and beta band oscillatory dynamics that may reflect the robustness of cortical circuits underlying cognitive processes – are commonly present in patients with clinically diagnosed cognitive impairment (dementia). The researchers theorized that there might be a link between dementia and postoperative delirium and thus also between postoperative delirium and cognitively normal patients whose EEG data exhibit similar biomarkers under anesthesia. They analyzed EEG data, collected using Masimo SedLine brain function monitoring, from 24 patients (21 cognitively normal, 3 with dementia). Analysis demonstrated a significant association between EEG point estimates for alpha/beta power and dementia (odds ratio of 1.43, 95% confidence interval of 1.14 to 1.79). Postoperative delirium for cognitively normal patients was associated with "visually evident decreased alpha/beta power," passing the threshold of statistical significance.

The researchers concluded, "Decreased alpha/beta oscillation power during sevoflurane general anesthesia is strongly associated with known cognitive impairment. This dynamic may be used to develop principled neurophysiological-based approaches to aid the preemptive identification and care targeting of vulnerable patients. Cognitively normal patients who developed postoperative delirium demonstrated a similar neurophysiological profile – but to a lesser extent – compared to patients with dementia to suggest that postoperative delirium may be more closely associated with sub-clinical cognitive impairment than previously appreciated."

SedLine brain function monitoring 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, recently released, features an enhanced signal processing engine, driving a variety of performance improvements, and an enhanced Multitaper Density Spectral Array (DSA). Next Generation SedLine can be used simultaneously with O3 regional oximetry on the Root® patient monitoring and connectivity platform for a more complete picture of the brain. O3 may help clinicians monitor cerebral oxygenation of adult and pediatric patients in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

@MasimoInnovates || #Masimo

References
1. Benkreira A, Beaubien-Souligny W, Denault A, and Mailhot T. Postoperative delirium and hepatic venous congestion: a prospective study. Proceedings from the 2018 IARS Annual Meeting, Chicago, Illinois. #1470.
2. Ibala R, Hahm, E, Maher S, Nebreda M, Garcia E, Nozari A, and Akeju O. Decreased EEG alpha/beta power during sevoflurane general anesthesia is associated with pre-existing cognitive impairment. Proceedings from the 2018 IARS Annual Meeting, Chicago, Illinois. #1173.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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 Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices

Lisbon, Portugal – April 19, 2018 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Annual Meeting of the Network for the Advancement of Patient Blood Management, Haemostatis and Thrombosis (NATA), in which researchers investigated the utility of Masimo noninvasive and continuous hemoglobin (SpHb®) in supporting and enhancing red blood cell (RBC) transfusion best practices as part of post-operative patient blood management (PBM).1

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

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

In the study, Prof. Baricchi and colleagues in the Transfusion Medicine Unit, AUSL-IRCCS of Reggio Emilia and at the Department of Medicine and Surgery at the University of Parma, Italy, sought to evaluate the appropriateness of post-operative RBC transfusion over a three-year period (2013-2015), before and after implementation of a patient blood management (PBM) program. The PBM policy consisted of three months of training followed by the introduction of noninvasive, continuous point-of-care (POC) monitoring of patient hemoglobin using Masimo SpHb on Masimo Radical-7® Pulse CO-Oximeters®. An initial audit of RBC transfusion appropriateness was conducted prior to the introduction of the PBM policy, on 168 patients. A final audit, after the policy was in place, was conducted on 205 patients. To determine transfusion appropriateness, investigators used the guidelines established by the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI).

The researchers found that prior to the introduction of the PBM policy, 37.7% of RBC transfusions were appropriate. After the introduction of the PBM policy, including use of noninvasive and continuous hemoglobin monitoring with Masimo SpHb, they found 65.4% of RBC transfusions were appropriate, a significant increase in transfusion appropriateness.

The researchers concluded that, "In our experience, the PBM strategies introduced improved RBC transfusion appropriateness in the post-operative period. We believe that our PBM policy and introduction of POC testing are a valuable support for the healthcare workers in the transfusion decision-making process. This enhancement of transfusion appropriateness implies clinical and managerial advantages, such as reduced transfusion-related risks, optimization of the health care resources and reduction of the costs."

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. Baricchi R, Marraccini C, Merolle L, Berni P, Bonini A, Mazzi A, Pertinhez T.A., and Di Bartolomeo E. Patient blood management: transfusion appropriateness in the postoperative period. Proceedings from the 2018 NATA Annual Meeting, Lisbon, Portgual. #P30.

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 http://www.masimo.com/evidence/featured-studies/feature/.

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 CE Marking of Rad-97™ Pulse CO-Oximeter® with Integrated NomoLine™ Capnography

Continuous Oxygenation and Ventilation Monitoring with Upgradeable rainbow® Parameters in a Compact, Standalone Device

Irvine, California – April 10, 2018 – Masimo (NASDAQ: MASI) announced today the CE marking of the Rad-97™ Pulse CO-Oximeter® with integrated NomoLine™ capnography. With this clearance, Rad-97 is now available both within and outside the United States in three configurations: Rad-97, Rad-97 with integrated noninvasive blood pressure, and now Rad-97 with NomoLine capnography. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion™ SET® pulse oximetry, upgradeable rainbow® technology, and NomoLine capnography in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.

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

Masimo Rad-97™ Pulse CO-Oximeter® with NomoLine™ Capnography

Rad-97 with NomoLine 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) values with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate. With both integrated capnography and Masimo acoustic respiration rate (RRa®) available on a single device, clinicians have the flexibility of choosing the most appropriate respiration monitoring method for each patient.

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 and capnography measurements to care areas where a small footprint or high portability is desired. 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.

"We're delighted to bring the full family of Rad-97 products to markets outside the United States," said Joe Kiani, Founder and CEO of Masimo. "We believe Rad-97, with its versatility and customizability, will play an especially important role in helping hospitals improve their monitoring capabilities with convenient, easy-to-use device and technology solutions – ultimately helping to improve patient care and safety."

Rad-97, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine capnography have received FDA 510(k) clearance and are also 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. 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 UniView™

UniView Aggregates and Displays Patient Data From Multiple Devices to Minimize Clinician Cognitive Overload and Maximize Patient Safety

Irvine, California – April 2, 2018 – Masimo (NASDAQ: MASI) announced today the release of UniView™, an integrated display of real-time data and alarms from multiple Masimo and third-party devices, designed to reduce clinician cognitive overload and improve patient safety. UniView promotes data sharing and team coordination among multiple clinicians.

In operating rooms (ORs), in intensive care units (ICUs), and in other areas which involve multiple clinical disciplines, clinicians are often unable to simultaneously view data from all of the various medical devices in use, resulting in information that remains siloed among, for example, anesthesiologists, surgeons, and nurses. In addition, the plethora of displays and user interfaces adds to cognitive overload that can cause clinician burnout and suboptimal patient care.

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

Masimo UniView™

UniView solves these problems by bringing together data from a variety of sources – such as patient monitors, ventilators, anesthesia gas machines, and IV pumps – and providing a supplementary display for them, clearly organized, on one or more large, central monitors, so that all clinicians can simultaneously view and act upon the same, comprehensive real-time patient status and historical trends. Visual alarm indicators, relayed from the connected devices, help clinicians recognize patient distress and target areas for immediate focus. UniView is suitable for any area where comprehensive, logically organized, and timely data are key to supporting good clinical care.

  • In Overview layout, view monitoring data from all connected point-of-care and therapeutic devices including waveforms and alarms, for an overview of patient status.
  • In Hemodynamics layout, view trend data for noninvasive hemoglobin (SpHb®), pleth variability index (PVi®), and pulse rate to aid in visualizing patient status over time.
  • In Oxygenation layout, view ventilator waveforms alongside noninvasive trended hemoglobin (SpHb) and oxygen saturation (SpO2) to monitor a patient's oxygenation status.
  • In Sedation layout, view high-fidelity EEG waveforms, patient state index (PSi), and anesthesia machine data to monitor a patient's sedation.

In addition, hospitals will be able customize the view as preferred and even take advantage of individual customization using Masimo MyView™ technology.

Joe Kiani, Founder and CEO of Masimo, said, "We are answering clinicians' calls for logical, clinically transformational cockpits for the collaborative ORs and ICUs of the future. UniView is a great example of Masimo's ongoing commitment to automating patient care, whether it's making pulse oximeters accurate when you need that accuracy most, creating new noninvasive monitoring technologies such as SpHb, or in this case, unsiloing data, enhancing connectivity, and communicating patient data as effectively and efficiently as possible, so that clinicians can focus more on their patients. We look forward to introducing additional enhancements soon – helping to bring automation and connectivity to the next level."

UniView builds on the success of Kite™, which projects data from Root® on a larger screen, by aggregating data from all of the connected devices in a room, including third-party ones, so that a supplemental display of all monitoring data can be viewed by all. UniView works in conjunction with Masimo Iris Gateway™ and Patient SafetyNet™* connectivity platforms. Complementing UniView, the recently announced Masimo Replica™ allows clinicians to view similar monitoring data for multiple patients, as well as view and respond to alarms and alerts, all from a smart phone, regardless of location.

@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 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 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 – Ma