New Study Of Masimo Corporation Noninvasive and Continuous SpHb® Monitoring Demonstrates Accuracy And Utility In Double-Jaw Surgery

IRVINE, CA--(Marketwired - June 18, 2014) -

Masimo (NASDAQ: MASI) announced today that in a new clinical study published in the Journal of Oral Maxillofacial Surgery, Masimo’s noninvasive and continuous hemoglobin (SpHb®) technology provided clinically acceptable accuracy and helped determine when to perform invasive laboratory hemoglobin measurements in patients undergoing double-jaw surgery when massive hemorrhage is anticipated.(1)

In the study, Dr. Sung-Hoon Kim, M.D., et al., at the Asan Medical Center, College of Medicine, University of Ulsan in Seoul, Korea, compared SpHb measurements using SpHb Adhesive Sensors (Revision E) and the Masimo Radical-7® Pulse CO-Oximeter with laboratory hemoglobin measurements from a CO-Oximeter (Stat Profile pHOx Plus) in elective Le Fort I osteotomy and bilateral sagittal split ramus osteomy (BSSO) jaw surgery.

Of 51 patients, the average laboratory hemoglobin (tHb) and SpHb values were 12.6 +/- 1.2 and 12.7 +/- 1.6 g/dL before incision, respectively. These values decreased significantly over the course of the surgery to 10.0 +/- 1.2 and 9.1 +/- 1.3 g/dL at closure, respectively. The difference between the SpHb and tHb was less than 1 g/dL for 53 to 75% of measurements and less than 2 g/dL for 92 to 96% of measurements, respectively, at each time point. The difference between the SpHb and tHb data pairs was not affected by patients’ mean arterial pressure, which was significantly decreased to a level of 50 to 60 mmHg during controlled hypotensive anesthesia.

The researchers stated that SpHb, “had a clinically acceptable bias compared with the conventionally measured tHb in the steady state,” adding that, “Continuous monitoring of hemoglobin may help to determine the appropriate time to perform an invasive measurement of hemoglobin in patients undergoing double-jaw surgery when using controlled hypotensive anesthesia.”

Background

Clinicians administer red blood cell transfusions based on a variety of factors including invasive hemoglobin measurements.(2) However, laboratory measurements are intermittent and often delayed, leaving clinicians without any indication of hemoglobin status for extended periods of time.(3)

While SpHb monitoring is not intended to replace blood draws, it nonetheless identifies significant changes in trends and lack of significant changes in hemoglobin between invasive blood sampling and laboratory analysis. SpHb monitoring enables clinicians to determine the real-time, directional trend of hemoglobin -- whether it is stable, rising, or falling. This can help clinicians avoid unnecessary transfusions when the SpHb trend is stable even though the clinician may otherwise perceive hemoglobin to be dropping, or when the SpHb trend is rising but the clinician may otherwise believe that it’s not rising fast enough. Inside and outside the operating room, a declining SpHb trend may also allow clinicians to identify internal bleeding and permit earlier interventions.(4)

SpHb is available with Masimo’s rainbow® SET monitoring platform enabling the noninvasive assessment of multiple blood constituents and physiologic parameters that previously required invasive or complicated procedures, in addition to providing Masimo SET® Measure through Motion and Low Perfusion™ pulse oximetry. The rainbow® SET® platform -- including RRa®, SpCO® and SpMet® -- offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.

1 Kim S-H, Choi J, Kim H, Choi S, Choi I. “Continuous Noninvasive Hemoglobin Measurement Is Useful in Patients Undergoing Double-Jaw Surgery.” Journal of Oral Maxillofacial Surgery. Published online March, 31 2014. doi:10.1016/j.joms.2014.03.011. Available online here
2 Zwart A, van Assendelft OW, Bull BS, et al: Recommendations for reference method for haemoglobinometry in human blood (ICSH standard 1995) and specifications for international haemiglobinocyanide standard (4th edition). J Clin Pathol 49:271, 1996
3 Vos JJ, Kalmar AF, Struys MM, et al: Accuracy of non-invasive measurement of haemoglobin concentration by pulse COoximetry during steady-state and dynamic conditions in liver surgery. Br J Anaesth 109:522, 2012
4 Awada W.F.N., Maher F. Reduction in Red Blood Cell Transfusions during Neurosurgery with Noninvasive and Continuous Hemoglobin Monitoring. Proceedings of the Society for Technology in Anesthesia Annual Meeting ; 2013 Jan 9-12; Phoenix AZ.

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 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 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). 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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