Medical Pioneer Masimo Announces the Full Market Consumer Release of the Masimo W1™, the First Watch to Offer Accurate, Continuous Health Data

Also Available, in Limited Market Release, Is Masimo W1 with Hydration Index, Designed to Provide Insight Into an Individual’s Hydration

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the full market release of the Masimo W1™ health watch for consumer use. The first of its kind, the Masimo W1 offers accurate, continuous measurements and insightful health data – from the leader in hospital pulse oximetry – in a personal, lifestyle-friendly, wrist-worn wearable. Building on Masimo’s decades of leadership in creating revolutionary noninvasive blood parameter monitoring solutions, Masimo W1 provides for the first time in a watch format, accurate, continuous monitoring of oxygen saturation (SpO₂), as well as pulse rate, respiration rate, and more, and, in a limited market release, hydration index – for consumers wanting to better understand their overall health, improve their fitness, or share their health data with friends and family. Taking 86,400 measurements a day for second-by-second trending, the Masimo W1 watch represents the future of personal health.

Known for its exceptional accuracy and reliability during challenging conditions, such as motion and low perfusion, Masimo is bringing its expertise in signal processing, photonics, and bio-sensing to consumers looking to take control of their personal health, make better health decisions, and monitor their overall physiological status. Paired via secure Bluetooth^® to the Masimo Health™ smartphone app, Masimo W1 provides continuous health data, unlocking meaningful, actionable insights, with accuracy unheard of in a wearable or watch.

Launching alongside the Masimo W1 is Personal SafetyNet™, a paid subscription service integrated within the Masimo Health app that gives users access to sophisticated reporting tools to help them review their physiological status over time. In addition, Personal SafetyNet facilitates sharing data with family members, fitness trainers, wellness coaches, and where allowed, healthcare providers, and even allows users the ability to set up virtual visits with doctors.

The Masimo W1 for consumers will be available for direct-to-consumer purchase starting immediately at www.masimo.com/masimo-w1. Masimo W1 comes with the Personal SafetyNet subscription service for consumers. Besides arterial oxygen saturation and pulse rate, Masimo W1 can also measure respiration rate, pleth variability index (PVi^®), perfusion index, pulse rate variability (PRV), heart rate variability (HRV), steps, and, under limited market release terms, Hydration Index (Hi™). As part of a future update, Masimo W1 will also be able to measure temperature and VO₂Max and provide 24/7 health data tracking and oversight.

Hydration level has been one of the most sought out parameters by athletes, vocalists, and others seeking to optimize their performance. Since creating PVi – which allows clinicians to assess fluid responsiveness of mechanically ventilated patients – nearly 15 years ago, Masimo has been working to invent a way to bring that measurement to consumers and those not on ventilators. Proper hydration is widely recognized as an important aspect of health and performance, and lack of proper hydration affects many physiological parameters, as the body works to restore homeostasis. Masimo W1 establishes your hydration baseline, helping you understand your hydration level, which not only affects athletic performance and fatigue, but can carry significant risks, especially for users with conditions like congestive heart failure. Whether you’re an elite athlete, a vocalist, living with a chronic illness, or just keen to gain more insight into your body’s physiological status, Masimo W1 with Hydration Index represents a breakthrough solution to better understanding and management of hydration.

Olympic silver medalist Morgan Pearson commented, “Masimo W1 is a gamechanger. As a professional triathlete, I’m always looking to optimize my performance in every way possible. With Masimo W1 I can continuously monitor lots of vital signs, even my level of hydration. This essential continuous data will help me track and improve my physiological performance in the most demanding of race conditions.”

Dotsie Bausch, also an Olympic silver medalist, added, “Masimo W1 delivers the next generation of accuracy in wearables. I trusted Masimo technology to catapult me onto the Olympic podium as the oldest competitor in history in my discipline. Masimo delivers superior accuracy through movement, which is the golden edge any athlete is looking for to produce their very best, every single time.”

Masimo is also entering the general launch phase of a medical version of Masimo W1 for use in medical applications outside the U.S., with additional measurement capabilities such as spot-check electrocardiogram (ECG), atrial fibrillation (A-fib) detection, and more. Benefiting from Masimo’s expertise in hospital connectivity and hospital automation, the medical Masimo W1 will also be available for use in telehealth and telemonitoring applications via Masimo SafetyNet^® and Personal SafetyNet for healthcare providers and payers, as well as individual use. For patients taking opioids to reduce pain or recovering at home after surgery or illness, as well as patients with chronic conditions (such as heart failure, COPD, or cancer), Masimo W1 will represent a convenient, reliable remote monitoring and telehealth solution enabling hospitals and clinicians to proactively keep track of their patients’ physiological status from afar, even as patients go about everyday tasks at home. A natural complement to the Masimo SafetyNet remote patient monitoring platform, Masimo W1 enables wireless transmission of patient data to the Masimo SafetyNet app and Masimo’s secure data cloud, where it will be reviewed in near-real time by remote monitoring teams in centralized locations for signs of physiological decline or sudden changes, such as falls or spikes in heart rate.

In Saudi Arabia, where Masimo W1 is already approved for use in medical applications, Dr. Bakhsh, Head of the Heart Function Unit at Prince Sultan Cardiac Center, said, “We have begun using Masimo W1 with Masimo SafetyNet for remote patient monitoring of our chronic heart failure patients. The watch is very comfortable to wear, and the continuous Masimo measurements give us confidence to help keep our patients safe.”

Dr. Chaudhry, Chief Clinical Information Officer (CCIO) and Chief Information Officer (CIO) at Cambridge University Hospitals NHS Foundation Trust (CUH), said, “We have deployed Masimo Patient SafetyNet™ on our Intermediate Dependency Care Unit for continuous monitoring with pulse oximetry, and believe it has made a genuinely positive impact on the safety of our patients. My initial experience with Masimo W1, the Masimo Health app and Personal SafetyNet monitoring service has been very positive. As we go forward caring for patients, whether in the hospital or at home as part of the virtual wards we are setting up, I am sure that this technology will be an excellent addition, supporting us in the delivery of ever increasing high-quality remote care for patients underpinned by personal, timely, and accurate clinical information.”

Dr. Amin, Professor of Medicine and Endowed Chair of Medicine at the University of California, Irvine, noted, “Masimo continues to innovate elegant noninvasive solutions to complex problems. The release of the Masimo W1 watch raises the bar on home wearables by providing pulse oximetry based on industry-leading SET^® technology and continuous monitoring features in a wrist-worn device. By doing so, we can follow our health and fitness beyond the home, to any location that has cell phone connectivity. I have personally worn Masimo W1 and am impressed by its comfort and stylish look—while able to continuously monitor my oxygen level, follow my step count, and track other health parameters, both at rest and during activity.”

Joe Kiani, Founder and CEO of Masimo, said, “With over 30 years of experience in medical monitoring and telemedicine, we are excited to bring the first wearable device to offer accurate and continuous pulse oximetry, hydration index, and other health measurements to consumers. The SET^® technology we invented for hospitals transformed patient monitoring, saved lives, and reduced the cost of care. Based on the feedback we have received from those who have tested Masimo W1 during the limited market release phase, we believe this watch will improve lives.”

In the U.S., Masimo W1 for use in medical applications is pending FDA clearance.

@Masimo | #Masimo

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.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 250 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ 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 Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION™, UniView^®, UniView :60™, and Masimo SafetyNet^®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies. 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. 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. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
4. 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.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. 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.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
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 W1^™. 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 technologies, including W1, contribute to positive clinical outcomes and patient safety; risks that Masimo W1 fails to be available as planned; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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.