New Study Evaluates the Ability of Masimo ORi™ to Help Clinicians Reduce Hyperoxemia in Mechanically Ventilated ICU Patients

Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Congress of the French Society of Anesthesia and Resuscitation (SFAR) in Paris in which researchers at CHU Angers in France investigated the ability of Masimo ORi™ (Oxygen Reserve Index) to help clinicians reduce the number of days ICU patients experience hyperoxemia while on mechanical ventilation.¹ ORi, available outside the U.S., is a noninvasive and continuous parameter intended as a relative indicator of a patient’s oxygen reserve during moderate hyperoxia (partial pressure of oxygen in arterial blood [PaO₂] in the range of 100 to 200 mmHg). ORi can be trended and has optional alarms to notify clinicians of changes in oxygenation.

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Noting that hyperoxemia can lead to patient morbidity and mortality in ICU patients, and that oxygen saturation (SpO₂) cannot detect hyperoxemia, Dr. Brochant and colleagues sought to evaluate whether ORi might be useful in helping clinicians determine when to reduce the fraction of inspired oxygen (FiO₂) during oxygen therapy, so as to avoid hyperoxemia. In this initial analysis, the first 131 patients in the study, whose data were collected between May 2017 and March 2018, were randomly assigned into an ORi and a control group. In the ORi group, FiO₂ was reduced if ORi was > 0. In the control group, the FiO₂ level was adjusted according to SpO₂. Clinicians recorded blood gas results, episodes of atelectasis, and the length of time spent on mechanical ventilation, for up to 28 days. The principal point of comparison was the proportion of ventilated days with hyperoxemia.

The researchers found that the percentage of days with hyperoxemia was significantly lower in the ORi group: median 14% [interquartile range 0-31%], vs. 29% [IQR 11-50%] in the control group, p=0.005. Average daily PaO₂ and FiO₂ values were not significantly different between the two groups, suggesting that FiO₂ was not systematically lowered in the ORi group. The average number of days without ventilation and median time spent in the ICU were also not significantly different.

The researchers concluded that the use of ORi may help clinicians reduce the percentage of days with hyperoxemia, that analysis of the full group of patients may allow assessment of its effect on the occurrence of atelectasis, and that additional studies may be useful in evaluating the impact of this monitoring on the morbidity and mortality of patients.

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

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Reference

1. Brochant A, Dupre P, Gaillard T, Lemarie P, Gergaud S, and Lasocki S. “ORi pour moins d’hyperoxie en reanimation.” Proceedings from SFAR 2018, Paris, France. #R244.

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 9 of the top 10 hospitals listed in the 2018-19 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^®), 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

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;Jan 8;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; 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.

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Contact information

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