Masimo Announces FDA Clearance of Radius PPG™, the First Tetherless SET® Pulse Oximetry Sensor Solution

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance of Radius PPG, a tetherless sensor solution powered by Masimo SET^® that represents a significant breakthrough in patient monitoring. Radius PPG eliminates the need for a cabled connection to a pulse oximetry monitor, allowing patients to move freely and comfortably while still being continuously monitored reliably and accurately. Via wireless connection, measurements are displayed on Masimo host devices or third-party multi-parameter monitors with integrated Masimo technology, making Radius PPG immediately available for approximately two million monitors around the world. Coupled with the proven benefits of Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, Radius PPG is suited for use anywhere patients can benefit from mobility.

Radius PPG gives patients freedom of movement without interrupting continuous monitoring. Wireless connection to a host device is simple to establish and each Radius PPG can easily pair with multiple devices (maintaining connection to any one device at a time), simplifying transfers between care areas. Radius PPG works with its integrated battery for about four days and stores up to four days (96 hours) of patient data; in the event of wireless interruption, Radius PPG provides seamless retransmission once the connection is restored. Automated by Masimo’s connectivity solutions, patient data can be used for remote clinician notifications of changes in patient condition and automatically transferred to the patient’s EMR.

Studies have shown that patient mobility is a key factor in more rapid patient recovery.^1,2 In addition, the removal of cables has been shown to contribute to greater patient comfort, convenience, and patient satisfaction compared to tethered patient monitoring.³ Radius PPG allows patients to move throughout the hospital room, to the bathroom, and to other care areas without the need for physical disconnection and reconnection. In places like the neonatal ICU, care providers and parents can hold infants without interrupting monitoring or risking an uncomfortable tug on the patient. Radius PPG not only offers patients improved comfort and convenience but improves clinician workflows.

Radius PPG harnesses the power of clinically proven Masimo SET^® technology to provide accurate measurement even while patients move. Over 100 independent and objective studies have shown that SET^® outperforms other pulse oximetry technologies during conditions of motion and low perfusion.⁴ When used in conjunction with Patient SafetyNet™, continuous monitoring using SET^® in post-surgical wards has been shown to reduce rapid response team activations and transfers back to the ICU.^5-7 Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity (ROP) in neonates⁸ and improve critical congenital heart disease (CCHD) screening in newborns.⁹ Today, Masimo SET^® is estimated to be used on more than 100 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 listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.¹¹

Joe Kiani, Founder and CEO of Masimo, said, “We are excited to announce the Radius PPG tetherless, wearable SET^® pulse oximetry sensor solution. Accurate, high-quality monitoring data can now travel from an ambulating patient to a variety of monitoring platforms, allowing a patient’s physiological status to be continuously monitored when it’s needed most.”

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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.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁸ improve CCHD screening in newborns,⁹ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-7 Masimo SET^® is estimated to be used on more than 100 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 listed in the 2018-19 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^®, 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. 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. Fensli R et al. J Med Syst (2010) 34: 767. https://doi.org/10.1007/s10916-009-9291-8.
4. 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.
5. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. 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.
9. 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.
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 PPG™ and SET^®. 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 PPG and SET^®, 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.