Medical Monitoring Pioneer Announces the Limited Market Release of the Masimo W1™ Watch for Consumers

Incorporated on May 2, 1989 as a garage startup dedicated to solving the “unsolvable” problem of inaccurate and unreliable conventional pulse oximetry under real-life conditions such as patient movement, Masimo and its breakthrough Measure-through Motion and Low Perfusion™ SET^® pulse oximetry today touch hundreds of millions of lives around the world each year.¹ SET^® pulse oximetry has been shown in more than 100 independent studies to outperform other pulse oximetry technologies,² and is the only pulse oximetry shown in numerous large studies – involving more than 300,000 infants – to improve critical congenital heart disease (CCHD) screening in newborns.^3-13 SET^® pulse oximetry has also been shown to improve outcomes for patients on opioids in post-surgical wards,^14-17 reduce eye damage and blindness in the neonatal intensive care unit,¹⁸ and reduce mortality among Covid patients remotely monitored at home.¹⁹ Through Masimo’s continued focus on innovation and improvement, SET^® has evolved to feature the industry’s highest accuracy specifications, on the new RD line of patient sensors; become tetherless, with the secure Bluetooth^®-equipped continuous Radius PPG™; and now, as the foundational technology driving the W1, has become a truly lifestyle-friendly technology for consumers outside hospitals.

For the limited market release of W1, Masimo is inviting a select group of early adopters to help evaluate and refine the product over the coming months. Masimo will provide up to 10,000 W1s on a first-come, first-served basis, at a 50% discount, to users who agree to the program details and to provide feedback and data to Masimo. For additional information and to express interest in the program, please go to www.masimo.com/w1.

With this consumer release of W1, Masimo is bringing its expertise in medical monitoring, connectivity, and automation to consumers looking to take control of their personal health, including those wanting to fine-tune their athletic training and recovery, the quality of their sleep, and their overall physiological status. Paired via secure Bluetooth^® to the Masimo Personal Health smartphone app, W1 provides continuous health data and guidance with accuracy heretofore unknown in a wrist-based device, unlocking meaningful, actionable insights—all in the convenient and discreet form of a durable watch.

Tommy Haas, former professional tennis player, commented, “I’ve always believed in the power of data to improve my performance. Accurate vital sign measurements have helped me track my activity and recovery both on and off the court. Now with Masimo W1, I have a convenient way to continuously track my vitals right on my wrist.”

In addition to use by consumers, W1 is also available outside the U.S. for telehealth applications, benefiting from Masimo’s expertise not only in noninvasive monitoring but in hospital connectivity and automation innovations. For patients recovering at home after surgery or illness, as well as patients with chronic conditions (such as heart failure, COPD, or cancer), W1 represents a convenient, reliable remote patient monitoring and telehealth solution enabling clinicians to 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, W1 enables wireless transmission of patient data to the Masimo SafetyNet smartphone app and Masimo’s secure data cloud.

Dr. Abeer Bakhsh, Head of the Heart Function Unit at Prince Sultan Cardiac Center in Saudi Arabia, which has been using W1 for telehealth monitoring of patients, commented, “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.”

Joe Kiani, Founder and CEO of Masimo, said, “As we celebrate our 33^rd year, and as we embark on the next chapter of our expansion through the recent acquisition of Bowers & Wilkins, Denon, Marantz, Polk Audio and their home automation technologies, it is only fitting that we are today debuting the first wearable device to offer accurate and continuous physiological measurements based on the technology we’ve honed for use in hospitals for more than three decades. From our own original breakthrough technology, SET^® pulse oximetry, to our advanced hospital monitors like Root^®, to our Hospital Automation™ platform and its many innovative connectivity and remote monitoring systems, to our tetherless Masimo SafetyNet remote and home patient management and telehealth solutions, and now to W1, we are excited to be able to bring our technologies directly to even more people everywhere.”

The Masimo W1 is not FDA cleared.

@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.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹⁸ improve CCHD screening in newborns,^4-13 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^14-17 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.²⁰ 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. Estimate: Masimo data on file.
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. 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. Lancet. 2014;384(9945):747-54.
5. Gunaratne CR et al. Sri Lanka J Child Health. 2021;50(1):04-11.
6. Slitine N et al. Int J Neonatal Screen. 2020;6(53).
7. Ewer AK et al. Lancet. 2011;378(9793):785-94.
8. de-Wahl Granelli A et al. Acta Paediatr. 2007;96(10):1455-9.
9. Meberg A et al. J Pediatr. 2008;152:761-5.
10. Schena F et al. J Pediatr. 2017;183:74-79.
11. Hamilçıkan S, Can E. J Perinat Med. 2018;46(2):203-207.
12. Jawin V et al. PLoS One. 2015;10(9):e0137580.
13. Gopalakrishnan S et al. Med J Armed Forces India. 2021;77(2):214-219.
14. 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.
15. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
16. 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.
17. 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.
18. 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.
19. Pronovost P, Cole M, Hughes, R. Remote Patient Monitoring During COVID-19: An Unexpected Patient Safety Benefit. JAMA. Published online February 25, 2022. doi:10.1001/jama.2022.2040.
20. 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.