Masimo Announces Pathway(TM), a Newborn Oxygenation Visualization Mode for the Root® Patient Monitoring and Connectivity Platform

Masimo (NASDAQ: MASI) today announced Pathway™, a feature for the Root^® Patient Monitoring and Connectivity Platform. Pathway provides clinicians with a way to visualize a hospital’s recommended resuscitation protocol for a newborn’s oxygen saturation (SpO₂) while continuously monitoring SpO₂ and pulse rate (PR) during the first ten minutes after birth. Use of Pathway is intended to help streamline clinician workflow and improve protocol adherence during this critical period. Pathway was invented by Dr. Yacov Rabi, MD, Associate Professor in the Department of Pediatrics at the Cumming School of Medicine, University of Calgary, Canada, and licensed to Masimo.

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Root® with Pathway™ (Photo: Business Wire)

The International Liaison Committee on Resuscitation (American Heart Association) has developed treatment recommendations outlining time-based SpO₂ targets that reflect a healthy newborn’s oxygenation during the first ten minutes after birth.¹ Current hospital practice relies on manually referencing charts or clinician recollection for adherence to protocols based on these recommendations. The ability to display local oxygen saturation targeting guidelines while still actively monitoring SpO₂ and PR via Pathway’s intuitive interface is intended to help clinicians more easily adhere to their institution’s resuscitation protocols. While Pathway is active, Root displays SpO₂ values alongside a visualization of the hospital-defined SpO₂ targets over time. To help clinicians track time since birth, Pathway displays an easily adjustable timer bar so that clinicians no longer need to mentally track the difference between the time of birth and the start of monitoring. Pathway can also provide hospitals with the ability to monitor and capture data involving adherence to their chosen newborn resuscitation protocols.

Dr. Rabi commented, “We created Pathway to simplify decision making during newborn resuscitation. I’m especially excited by the ability to review oxygen-saturation-targeting performance post-resuscitation as a means of supporting quality improvement and quality assurance initiatives at each institution.”

Pathway’s visualization on Root works in tandem with continuous SpO₂ monitoring powered by Masimo SET^® Measure-through Motion and Low Perfusion™ technology, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Crucially for newborn health, SET^® has been shown to help clinicians reduce severe retinopathy of prematurity in neonates³ and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns.^4-5

Masimo Root is a powerful, versatile, and ever more expandable monitoring and connectivity hub designed for use across the continuum of care. Root integrates an array of technologies, devices, and systems to provide multimodal monitoring and automation solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with core Masimo technologies such as SET^® pulse oximetry and rainbow^® Pulse CO-Oximetry while incorporating additional modalities such as SedLine^® brain function monitoring, O3^® regional oximetry, NomoLine^® capnography, and more – all via an easy-to-interpret, customizable display that can also be set to Vital Signs Check mode and now Pathway mode. Using Root in combination with Patient SafetyNet™ or Iris Gateway™, monitoring data can be automatically charted in electronic medical records (EMRs).

Joe Kiani, Founder and CEO of Masimo, said, “From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET^® pulse oximetry was designed with newborns and infants in mind. These patients were never an afterthought, and we continue to seek new ways to help clinicians provide them with the best care possible. One such result is Pathway, which visualizes the reliable, accurate data harnessed by SET^® in an innovative and intuitive new manner. We hope that Pathway will help clinicians more efficiently and easily keep track of a newborn’s status during the critical first minutes after birth.”

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-8 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET™ sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. 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^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius™ PPG, portable devices like Rad-67™, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97™. Masimo hospital automation and connectivity solutions are centered around the Iris^® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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/evidence/featured-studies/feature/.

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

References

1. https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000267.
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. 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.
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.
9. Estimate: Masimo data on file.
10. 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 Pathway™, SET ^®, and 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 Pathway™, SET ^®, and Root, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

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