Masimo Announces Limited Market Release of Radius VSM™

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that Radius VSM™, a wearable, tetherless vital signs monitor, has received CE marking and is being released in limited European markets. The versatile, expandable Radius VSM provides the ability to monitor a wide variety of physiological measurements, including continuous SET^® pulse oximetry, noninvasive blood pressure, body temperature, respiration rate, and electrocardiography (ECG). Designed on a wearable, modular platform, Radius VSM features can be scaled to accommodate surges in patient volume and for use across the continuum of patient care, based upon each patient’s needs and level of acuity. For additional versatility, Radius VSM can operate as a self-contained device or be used wirelessly with Masimo bedside monitors and patient surveillance systems—automating the integration of expanded monitoring and the transfer of continuous monitoring data to electronic medical records (EMRs).

As a comprehensive, scalable solution, Radius VSM has potential clinical utility in a multitude of care scenarios while also encouraging ambulation and freedom of movement, which studies have shown to be a key factor in more rapid patient recovery.^1-2 Configurable with a variety of modules and noninvasive sensors designed to prioritize comfort and ergonomics, care teams can seamlessly increase or decrease the technologies monitored based on each patient’s needs, without additional bedside equipment, infrastructure, or tethered connections. Radius VSM offers the following wearable technologies:

• Clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry,³ including oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), PVi^® fluid responsiveness, and RRp^® plethysmographic respiration rate
• ECG with heart rate, respiration rate, and advanced lethal arrhythmia detection using 3-leadwire single-patient-use electrodes offering 6 ECG waveforms: I, II, III, aVR, aVL, and aVF
• Measure-on-inflation noninvasive blood pressure that features single-patient-use cuffs, customizable scheduling (eliminating the need for periodic manual clinician measurement), and variable inflation speeds; for example, quicker for ambulating patients and slower for resting patients, minimizing the possibility of sleep disruption
• Continuous body temperature measurements with notifications when clinician-specified temperature thresholds are breached
• RRa^® continuous acoustic respiration rate monitoring using rainbow Acoustic Monitoring^®, which converts the acoustic patterns caused by the patient’s airflow into breath cycles to calculate respiration rate and visualize an acoustic respiration waveform

Radius VSM features a high-resolution touchscreen and the ability to store and display up to four hours of trend and waveform data on the device itself, providing additional clinical context at the point of care for nurses, therapists, and doctors when interacting directly with patients. In addition, Radius VSM’s rechargeable battery lasts over twelve hours between charges; two devices are supplied for each bedside to provide uninterrupted functionality. Radius VSM has a rugged, durable exterior designed to withstand busy hospital environments and drops of up to one meter, and is water resistant.

Radius VSM can communicate via Bluetooth^® to the Root^® Patient Monitoring and Connectivity Hub at the bedside, for enhanced visibility on Root’s display. The device can also independently communicate via Wi-Fi to the Patient SafetyNet™ Supplemental Remote Monitoring and Clinician Notification system, enabling use as a patient surveillance system monitored from central viewing stations. The ability to track continuous vital signs and telemetry data from afar is an especially relevant feature for clinicians in the context of COVID-19 and other contagious conditions, where staying informed of patient status while minimizing the risk of cross-contamination can be essential to effective patient care. In addition, automated remote data transfer from Radius VSM to electronic medical records (EMRs) ensures that up-to-date physiological data is always available to clinicians and systems throughout the hospital, without the need for time-consuming manual transcription.

Joe Kiani, Founder and CEO of Masimo, said, “Radius VSM offers the reliability and accuracy of a bedside monitor with the flexibility of a wearable device, thus opening the door to numerous new uses, made possible by its unique scalability and broad range of automated, continuous measurements. We’re excited for clinicians and patients in Europe to experience the advantages of Radius VSM, and look forward to making it available to the rest of the world as regulatory clearances are obtained.”

@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.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 according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹¹ 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^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. 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. Needham D et al. Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
2. Ronnenbaum J et al. J Acute Care Phys Ther. 2012;3(2):204-210.
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. 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 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.
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 Radius VSM™, SET^®, and RRa^®. 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 Radius VSM, SET^®, and RRa, 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; 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.