Masimo Nabs FDA Clearance of O3 Regional Oximetry for Pediatric Patients

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ:MASI) announced today FDA 510(k) clearance for the pediatric indication for O3™ regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With the clearance of the O3 pediatric sensor, O3 regional oximetry monitoring, which was already available for adult patients in the United States, is now also available for pediatric patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).

“Cerebral and somatic venous oximetry in adults and infants.”

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO₂) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain are important tools in helping patients avoid postoperative morbidity and adverse outcomes.¹

“O3 regional oximetry provides access to valuable data about cerebral oxygen saturation,” said Joe Kiani, Founder and CEO of Masimo. “With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively,² without controlling CO₂, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old.²”

In addition, Masimo O3 regional oximetry and SedLine^® brain function monitoring are both available on a single platform, Masimo Root^® – opening up a path to better understanding of the brain.

@MasimoInnovates | #Masimo

References
1.		Booth, Dukatz, Ausman, and Wider. “Cerebral and somatic venous oximetry in adults and infants.” Surg. Neurol Int. 2010; 1: 75.
2.		Masimo data on file.

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 by taking noninvasive monitoring to new sites and applications. 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,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.⁷ 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^®), and more recently, Pleth Variability Index (PVi^®) and 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/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1.		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.
2.		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;338.
3.		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.
4.		Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5.		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.
6.		Estimate: Masimo data on file.
7.		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 O3™ Regional Oximetry. 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 O3 Regional Oximetry, contribute to positive clinical outcomes and patient safety; 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.