New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™

Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the recent International Anesthesia Research Society (IARS) Annual Meeting in Washington, DC. In the study, researchers at the UC Davis School of Medicine evaluated the potential clinical utility of Masimo Oxygen Reserve Index™ (ORi™) as an early warning of arterial hemoglobin desaturation in critically ill patients.¹

ORi is a relative indicator of the partial pressure of oxygen in arterial blood (PaO₂) in the range of 100 to 200 mmHg. ORi is intended to supplement, not replace, oxygen saturation (SpO₂) monitoring and PaO₂ measurements. As an “index” parameter with a unit-less scale between 0 and 1, ORi can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.

In the prospective, collaborative, observational study, Dr. Leonard Lee and colleagues enrolled 40 adult critically ill patients who were scheduled for elective surgical procedures requiring endotracheal intubation and planned arterial pressure monitoring catheter placement prior to induction of general anesthesia. The patients’ ORi values were measured using a Masimo Radical-7^® Pulse CO-Oximeter^®. The researchers recorded the time elapsed from the start of ORi alarming (triggered by decrease in the absolute value and rate of change in ORi) to 94% oxygen saturation, as well as the time elapsed from 98% to 94% saturation. The average time interval between the start of ORi alarming and 98% saturation was considered to be the average increase in warning time provided by ORi.

The researchers found that among the patients, the average time from the start of ORi alarming to 94% oxygen saturation was 80±38 seconds (ranging from 29 to 227 seconds). The average time from 98% to 94% saturation was 46±23 seconds (ranging from 12 to 108) seconds. Therefore, the average increase in warning time provided by ORi was 34±23 seconds (ranging from 4 to 119) seconds. On a percentage basis, the increase provided by ORi was 96%±92% (ranging from 5% to 479%).

The researchers concluded that the study “demonstrates the potential utility of ORi as an advanced warning of arterial desaturation and as an adjunct to SpO₂. This additional warning time can potentially translate to improved patient safety by allowing earlier calls for help, assistance from a more experienced person, or modification of airway management. For this analysis we defined the advance warning to end at 98% SpO₂. In clinical situations this SpO₂ might not be considered to be critical. Using a lower SpO₂ as the alarm level would increase the advance warning provided by ORi. Further analysis of the correlation of ORi and PaO₂, the use of ORi as a guide to pre-oxygenation, and its utility in the morbidly obese are areas for future study.”

In another recent study, researchers at Children’s Medical Center in Dallas, Texas concluded that ORi could provide clinicians with a median of 31.5 seconds advanced warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation.²

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates | #Masimo

References
		1.		Lee L, Singh A, Applegate R, and Fleming N. Oxygen Reserve Index: An early warning for desaturation in critically ill patients. Proceedings from the 2017 IARS Annual Meeting, Washington, DC. Abstract #A1406.
		2.		Szmuk P et al. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.

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,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 and is the primary pulse oximetry at 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 ORi™. 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 ORi, 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.

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Contact information

Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com