In New Study EMMA™ Capnograph Has Comparable Accuracy to Sidestream Capnography Against Gold-Standard Blood Gas Analysis

Masimo (NASDAQ: MASI) announced today that in a new study that compared the end tidal carbon dioxide values (EtCO₂) from both the Masimo EMMA capnograph and a conventional sidestream capnography device to the gold-standard carbon dioxide measurement, arterial blood gas (PaCO₂), EMMA produced “reliable” values and had similar accuracy as sidestream capnography.¹

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Carbon dioxide levels in the blood reflect the degree of gas exchange occurring in the lungs and provide a critical indicator of cardio-respiratory function that aids in the assessment of the adequacy of ventilation. PaCO₂ is considered the gold standard to measure carbon dioxide levels but requires invasive blood sampling and laboratory analysis that can provide intermittent and delayed measurements. EtCO₂ monitoring with capnography provides a noninvasive and continuous estimate of PaCO₂ and has become a standard of care in the operating room and other critical care areas.² Since 2010, the American Heart Association (AHA) has recommended the use of EtCO₂ during cardiopulmonary resuscitation (CPR) for “confirmation and monitoring of endotracheal tube placement.”³ Conventional capnography monitors require warm-up time to calibrate and measure EtCO₂ from a sampling line connected to the breathing circuit. In contrast to bulkier and slower-to-calibrate sidestream capnography monitors, the EMMA is a compact and lightweight mainstream capnograph that clips directly onto the breathing circuit with no sampling line and minimal warm-up time.

The study, published in the Journal of Clinical Monitoring and Computing by Dr. Kyung Woo Kim and colleagues from Seoul Park Hospital, College of Medicine, Seoul, Korea, compared 100 EtCO₂ values from both the EMMA and sidestream capnography (Datex Ohmeda S5 Anesthesia Monitor) in 35 patients undergoing general anesthesia to PaCO₂ values measured from blood gas analysis (GEM Premier 3000) of simultaneously collected arterial blood samples. Compared to PaCO₂, EMMA had a bias of 6.0 mm Hg with a percent error of 18% and sidestream capnography had a bias of 3.8 mm Hg with a percent error of 20%.

The authors concluded “EMMA capnometers are viable and lighter weight alternatives to legacy capnometers, as they produce capnographs and reliable EtCO₂ values rapidly despite their small size and light weight.” The authors also noted that “the data used in this study were only collected in situations of stable and normal respiration under general anesthesia,” and “that the limitations affecting the prediction of the PaCO₂ values are in accordance with the condition of the patient.”

For more information on the EMMA capnograph, go to www.masimo.com.

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1. Kim (et al.), Comparison of end-tidal CO2 measured by transportable capnometer (EMMA capnograph) and arterial pCO₂ in general anesthesia. J Clin Monit Comput 2015; published online.
2. ASA Standards for Basic Anesthetic Monitoring. 2011.
3. Field (et al.), Part 1: executive summary: 2010 American Heart Associated ion guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010; 122: S640-56.

About Masimo

Masimo (NASDAQ: MASI) is the 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. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). The indications for EMMA include the following: 1) The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 2) The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. Additional information about Masimo and its products may be found at www.masimo.com.

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 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: total hemoglobin (SpHb®) 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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Masimo
Media Contact:
Irene Paigah, 858-859-7001
irenep@masimo.com