Study Compares Performance of Masimo Acoustic Respiration Rate (RRa®) and Nellcor Plethysmographic Respiration Rate in Volunteers

Masimo (NASDAQ: MASI) announced today that researchers at the Tokyo Women’s Medical University, Department of Anesthesiology, in Japan have published a study investigating the measurement of respiration rate in volunteers. Masimo acoustic respiration rate (Masimo), using the Masimo Radical-7^® Pulse CO-Oximeter^®, was studied alongside Nellcor plethysmographic respiration rate (Nellcor), using the Nellcor PM1000N.¹

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Dr. Kitsiripant and colleagues enrolled 50 healthy adult volunteers in the study. Respiration rate, pulse rate, and oxygen saturation (SpO₂) values were measured using the two technologies: Nellcor respiration rate, pulse rate, and SpO₂ on PM1000N (version 2.0.20.0) were measured using an SpO₂ adhesive sensor on the left index finger; Masimo respiration rate on Radical-7 (V.7910, processor V1.3.06i) was measured using the RAS-125c (rev D) acoustic sensor on the left side of the neck, with an R1-25L adhesive sensor on the right index finger measuring Masimo pulse rate and SpO₂.

Both devices were configured to alarm in the event of respiratory pause (Masimo) or low respiration rate (Nellcor) for 30 seconds, respiration rate under 10 breaths/minute, and SpO₂ of 90% or below. The volunteers were required to breathe at a rate of 12 breaths/minute for 3 minutes, then hold their breath until one of the device’s respiratory pause/low respiration rate alarms was triggered, then resume breathing. Because of the difficulty for some volunteers of completely stopping airflow for 30 seconds, a smaller group of 10 volunteers was recruited to perform the same procedure but with respiratory pause/low respiration rate alarms set to 15 seconds.

Of the 143 procedures in which breathing was successfully held for more than 30 seconds, Masimo alarmed 114 times and Nellcor alarmed 15 times. The average time to alarm for Masimo was 35 seconds and for Nellcor, 59 seconds. Most of the alarms for Nellcor followed from SpO₂ being < 90%, whereas most for Masimo were caused by respiration rate < 10 breaths/minute (which tended to occur prior to the drop in SpO₂). Of the 29 procedures in which breathing was held for 15 seconds, Masimo alarmed 29 times, with an average time to alarm of 21 seconds, and Nellcor did not alarm at all.

The researchers concluded that Masimo acoustic respiration rate provided faster detection of respiratory pause than Nellcor, but it should be noted as a limitation of the study that the measurements were taken using volunteer participants who maintained a fixed breathing rate and then abruptly held their breath.

rainbow Acoustic Monitoring^® sensors and cables are indicated for the continuous, noninvasive monitoring of respiratory rate (RRa^®). The RAS-125c sensor is indicated for adult and pediatric patients, in hospitals, hospital-type facilities, mobile and home environments.

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Reference

1. Kitsiripant C et al. Comparison of Nellcor™ PM1000N and Masimo Radical-7^® for detecting apnea in volunteers. J Anesth. 9 July 2017. DOI: 10.1007/s00540-017-2385-4.

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^®), 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/cpub/clinical-evidence.htm.

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;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 RRa^®. 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 RRa, 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