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Masimo Announces FDA Clearance of RRp®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter

MASI | January 28, 2019

Masimo Announces FDA Clearance of RRp^®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter

Masimo MightySat Rx, Now Also Indicated for Use at Home, is the First Fingertip Pulse Oximeter with SET^® and the First to Measure Respiration Rate

Masimo (NASDAQ: MASI) announced today FDA clearance of the measurement of respiration rate from the pleth (RRp^®) on the MightySat™ Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment. The addition of RRp to MightySat Rx, which also measures functional oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi^®), makes it a more thorough and versatile spot-check solution.

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Masimo MightySat™ Rx with RRp® (Photo: Business Wire)

Respiration rate, or the number of breaths taken per minute, typically requires manually counting breaths with a timer and then converting to a rate per minute, or being fitted with chest leads or straps that can be inconvenient. With RRp, respiration rate can conveniently be measured using the same optical sensor that measures SpO₂, PR, Pi, and PVi. RRp is provided only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during certain conditions, such as very irregular breathing and excessive movement.

With the introduction of RRp to the U.S., Masimo now offers clinicians more ways to accurately measure breathing rate than ever, helping to ensure they have the right tools for each patient scenario. RRp on MightySat Rx offers a convenient, fast, and portable option, adding to the portfolio of respiratory solutions from Masimo that includes continuous, acoustic respiration rate monitoring using RRa^® and capnography-based solutions using NomoLine^®.

Alongside RRp, PVi, PR, and Pi, MightySat Rx features the same Measure-through Motion and Low Perfusion™ SET^® pulse oximetry available in a variety of bedside Masimo and OEM monitors. SET^® has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies,¹ is estimated to be used on more than 100 million patients a year,² 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.³ The benefits of SET^® are maximized by choosing the correct sensor type for each use scenario: adhesive sensors for continuous monitoring, reusable sensors for short-term monitoring, and MightySat Rx fingertip oximeters for spot-check measurements.

MightySat Rx is small and light, weighing less than 100 grams (with batteries), but also durable and long-lasting, with an IP23 ingress rating (protected from water spraying from up to 60 degrees from vertical) and providing approximately 1,800 spot-checks with each set of 2 AAA batteries. Available in both black and white, MightySat offers a high-resolution color display, including display of plethysmographic waveforms, as well as a Bluetooth^® wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements.

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About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. 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 activations and costs.^6-8 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,² 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.³ 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^®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect^® (MOC-9^®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7^® wearable patient monitor, iSpO₂^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

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.
Estimate: Masimo data on file.
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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.
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.
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.
Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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.

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 MightySat™ Rx and RRp^®. 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 MightySat Rx and RRp, 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.