Masimo Announces the Limited Market Release of Visual Clinical Activity Monitoring (VCAM™)

AI-Based Video Analysis System Promotes Hand Hygiene Compliance, Integrates with Masimo Hospital Automation™ Platform

Masimo (NASDAQ: MASI) today announced the limited market release of Visual Clinical Activity Monitoring (VCAM™), a video analysis system that uses artificial intelligence to help facilitate compliance with hospital hand hygiene protocols. VCAM, which integrates seamlessly with the Masimo Hospital Automation™ platform of solutions, including Masimo Patient SafetyNet™, Replica^®, and Root^®, is designed to help hospitals and other care facilities optimize protocol adherence, with real-time notifications at the point-of-care about current hand hygiene status and powerful analytics around protocol compliance – with the ultimate goal of helping institutions decrease the incidence of hospital-acquired infections (HAIs).

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Masimo VCAM™ with Root® (Photo: Business Wire)

Hand hygiene is well known to be an important factor in infection control activities, with numerous studies showing that washing one’s hands is the “single most important, simplest, and least expensive means of reducing the prevalence of HAIs and the spread of antimicrobial resistance.”¹ A recently published study conducted across multiple sites over eight years in Finland, for example, found a direct correlation between increased compliance with hand hygiene protocols and decreased incidence of HAIs.² However, in the absence of “active” hand hygiene initiatives – programs, for example, designed to measure and automate compliance – the compliance rate with such protocols rarely exceeds 40% in hospitals and other healthcare institutions.¹

Masimo VCAM, powered by Masimo’s expertise in AI-enabled algorithms and based on each facility’s standards, makes it easier for hospitals to optimize staff adherence to hand hygiene protocols by providing notifications on the spot, tracking compliance, and automating reporting. VCAM detects when clinicians are performing hygiene activities, such as washing hands or using an alcohol-based sanitizer, and identifies when they interact with people and objects, as well as when they touch or pick up an object from a potentially unclean surface such as the floor. Immediate notifications about current hygiene status are relayed to individual clinicians on bedside Root monitors and on Replica-equipped smartphones, prompting them, for example, to wash or sanitize their hands when they may have neglected to do so. In turn, VCAM’s rich reporting capabilities provide detailed analysis, such as the rates of clean vs. dirty incidents (which can be filtered by room and by department), helping leadership target opportunities for workflow improvements.

Vijay Dhar, MD, Chief of Neonatology at Children’s Hospital of Orange County (CHOC), California, said, “We, at CHOC, are eagerly anticipating the deployment of Masimo VCAM, the innovative artificial intelligence (AI) system that can characterize hand hygiene compliance. We hope VCAM will be able to help us to decrease hospital-acquired infections (HAIs), including viral pathogens such as respiratory syncytial virus (RSV), bacterial organisms such as MRSA, and other nosocomial organisms responsible for central line associated blood stream infections (CLABSI), the most common form of nosocomial infection affecting neonates. With Masimo VCAM helping us maintain hand hygiene, we aim to diminish these totally preventable HAIs and improve the safety and wellbeing of our neonates.”

Joe Kiani, Founder and CEO of Masimo, said, “VCAM adds an important new tool to the growing Masimo ecosystem of Hospital Automation products, building on our experience developing breakthrough algorithms and next-generation connectivity solutions, to help streamline hospitals’ ability to meet compliance goals with as fundamental and critical a task as hand-washing. VCAM aligns with our continued mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.”

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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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.¹¹ 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^®, Radius PPG^®, and Radius VSM™, 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 and home 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^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and the Masimo W1™ watch. 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, RPVi, and Radius VSM 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. Mathur P. Hand hygiene: back to the basics of infection control. Indian J Med Res. 2011 Nov;134(5):611-20.
2. Ojanperä H, Ohtonen P, Kanste O, Syrjälä H. Impact of direct hand hygiene observations and feedback on hand hygiene compliance among nurses and doctors in medical and surgical wards: an eight-year observational study. J Hosp Infect. 2022 Sep;127:83-90.
3. 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.
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 A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. McGrath S, Perreard I, Garland M, Converse K, and Mackenzie T. Improving patient safety and clinician workflow in the general care setting with enhanced surveillance monitoring. J Biomed Health Infor. DOI 10.1109/JBHI.2018.2834863.
9. 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.
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 VCAM™, Hospital Automation™, Patient SafetyNet™, Replica^®, 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 VCAM, Hospital Automation, Patient SafetyNet, Replica, and Root, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; 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.

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