Multicenter Study Shows Clinical Value of rainbow(R) Acoustic Monitoring (RAM)

Researchers Conclude RAM Has Potential to Increase Pediatric Patient Safety

Marketwired

IRVINE, CA--(Marketwired - Oct 8, 2013) - Masimo (NASDAQ: MASI) announced today a new study in Pediatric Anesthesia demonstrating Masimo's noninvasive, continuous rainbow® Acoustic Monitoring (RAM™) had similar accuracy, yet better patient tolerance compared to capnography (nasal cannula) in post-surgical pediatric patients.1

The study, which compared the performance of rainbow® Acoustic Monitoring to capnography in a pediatric patient population, adds to the growing body of evidence that shows the efficacy of RAM (including accuracy, precision, and better patient tolerance) in adult and pediatric patient populations.2,3,4,5

RAM is a breakthrough respiration rate (RRa) measurement used with a cloth adhesive sensor worn on the neck that allows clinicians to noninvasively and continuously assess patients' breathing, facilitating earlier detection of respiratory compromise and patient distress.

In the multicenter study at Cincinnati Children's Hospital Medical Center, University of Arizona Medical Center, and Children's Medical Center at Dallas, researchers found, "When compared to nasal capnography, RRa showed good agreement and similar accuracy and precision but was better tolerated in post-surgical pediatric patients."

The difference in bias and precision between the two test methods was not statistically significant (p=0.41).

Investigators concluded: "Acoustic monitoring has the potential to increase the safety of pediatric patients by providing a reliable and accurate method for the continuous monitoring of respiration rate."

STUDY RESULTS

Comparison of Methods   Bias +/- SD (bpm)   Limits of Agreement (bpm)
RRa with Capnography (Oridion Capnostream 20)   -0.3 ± 3.5   -7.3 to 6.6
RRa with Reference   -0.1 ± 2.5   -5.0 to 5.0
Capnography (Oridion Capnostream 20) with Reference   0.2 ± 3.4   -6.8 to 6.7
         

Six of the 40 patients in the study immediately removed the nasal cannula and would not permit it to be reapplied (and were not included in data collection); nine of the remaining 34 patients removed it prior to study completion (but were included in data collection). Only one patient removed the RRa sensor after 80 minutes of monitoring time.

The reliability of capnography was 92% of total monitoring time and the reliability of RRa (used with a Masimo Rad-87™ bedside monitor) was 90% of monitoring time; the difference was not statistically significant (p=0.54). Total duration of monitoring time and average per patient was 2,650 minutes and 76 minutes for capnography and 2,849 minutes and 83 minutes for RRa.

Steve Barker, M.D, Ph.D., Interim Chief Medical Officer of Masimo, stated: "This study shows that because RAM is as accurate and is better tolerated than capnography, more post-surgical pediatric patients are likely to remain monitored longer, potentially increasing patient safety and improving outcomes. Additionally, where capnography is not a standard of care -- such as PACUs and general floors -- RAM, due to its ease of use may enable continuous respiration rate monitoring which could improve patient safety considerably."

1 Patino M., Redford D.T., Quigley T.W., Mahmoud M., Kurth C.D., Szmuk P. Accuracy of acoustic respiration rate monitoring in pediatric patients. Pediatric Anesthesia. 2013 Sep 3.
2 Macknet M.R., Kimball-Jones P.L., Applegate R.L., Martin R.D., Allard M.W. Accuracy and Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric Patients. Anesthesiology 2007; 107: A84.
3 Ramsay M. Usman M. Lagow E. Mendoza M. Untalan E. De Vol E. The Accuracy, Precision and Reliability of Measuring Ventilatory Rate and Detecting Ventilatory Pause by Rainbow Acoustic Monitoring and Capnometry. Anesthesia & Analgesia. July 2013
4 Mimoz et al. Accuracy of respiratory rate monitoring using a non-invasive acoustic method after general anaesthesia Br. J. Anaesth. (2012) 108(5): 872-875 first published online February 8, 2012
5 Goudra B.G., Penugonda L. Monitoring Respiration in Upper GI Endoscopy Anesthesia. Proceedings of the 2011 Annual Meeting of the American Society of Anesthesiologists. A246.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care--helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." 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, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results and performance of Masimo rainbow® Acoustic Monitoring; our belief that the breakthrough acoustic respiration rate monitoring capabilities of Masimo's proprietary RRa technology will provide sufficient sensitivity and specificity to measure respiratory rate in a variety of patients and monitoring conditions, enabling clinicians to detect and treat respiratory compromise and patient distress earlier; 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

Contact:
Media
Mike Drummond
Masimo Corporation
(949) 297-7434
mdrummond@masimo.com

Rates