New Clinical Study Reports Relationship Between Masimo’s Oxygen Reserve Index (ORI™) and Arterial Partial Pressure of Oxygen During Surgery

Thursday, March 31, 2016

NEUCHATEL, Switzerland--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) announced today that a new retrospective study reports the relationship between Masimo’s Oxygen Reserve Index (ORI™) and arterial partial pressure of oxygen (PaO2) during surgery. The study suggests that ORI may provide an advanced indication of impending desaturation in adults undergoing surgery based on trends in the relationship between ORI and PaO2.1

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Masimo Root with ORI (Photo: Business Wire)

Masimo Root with ORI (Photo: Business Wire)

ORI, Masimo’s 11th rainbow® parameter2, which is available outside of the United States, is a relative index of the PaO2 operating in the range of 100 to 200 mm Hg. ORI can provide a calculated oxygen reserve index that may add to information from pulse oximetry when oxygen saturation (SpO2) is >98%. ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements.

In the study, published in the journal Anesthesia & Analgesia and conducted at Loma Linda University, Dr. Applegate and colleagues studied 106 patients in which arterial catheterization and intraoperative arterial blood gas analysis were planned during surgery. Multiwavelength Pulse CO-oximetry data from multiple sensors on each patient were continuously collected (Masimo Radical-7® with Root®). A retrospective analysis was then conducted to evaluate the ORI to PaO2 relationship.

Regression analysis showed a positive ORI to PaO2 relationship for PaO2 values up to 240 mm Hg (r2 = 0.536), but not for PaO2 over 240 mm Hg (r2 = 0.0016). Measured PaO2 was ≥100 mm Hg for all ORI values over 0.24, and when ORI was higher than 0.55, the measured PaO2 was ≥150 mm Hg in 96.6% of samples.

The investigators concluded, “This study suggests that intraoperative ORI can distinguish PaO2 between 100 and 150 mm Hg when SpO2 is >98%. Decreases in ORI to near 0.24 may provide advance indication of falling PaO2 when SpO2 is still >98% and above the PaO2 level at which SaO2 [arterial oxygen saturation] declines rapidly. Usefulness of ORI >0.24 to distinguish PaO2 ≥100 mm Hg and ORI >0.55 to distinguish PaO2 ≥150 mm Hg should be tested prospectively in a range of clinical settings.” Additionally, the investigators noted that “the clinical utility of interventions based on continuous ORI monitoring should also be studied prospectively,” and that other clinical or feasibility limitations may not have been identified. The authors also noted that the study was limited by a small number of subjects and samples with PaO2 values <100 mm Hg, and that the study results did not apply to intensive care settings.

The Loma Linda University School of Medicine, Department of Anesthesiology received a grant from Masimo to support the data collection for this study.

Radical-7 with Root has a CE Mark with the ORI parameter. ORI has not received FDA 510(k) clearance and is not available for sale in the United States.

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1. Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Mar 22. [Epub ahead of print] PubMed PMID: 27007078.

2. The 11 rainbow® parameters include: 1) oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI®); 5) Respiration Rate from the pleth (RRp®); 6) Total hemoglobin (SpHb®); 7) Oxygen Content (SpOC™); 8) Carboxyhemoglobin (SpCO®); 9) Methemoglobin (SpMet®); 10) Fractional oxygen saturation (SpfO2®); 11) Oxygen Reserve Index (ORI™)

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® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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’s Oxygen Reserve Index (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’s Oxygen Reserve Index (ORI™), contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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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