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

 

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.