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Independent Study Concludes Masimo Engineering Prototype is the First Technology to Measure Total Hemoglobin Continuously and Noninvasively, Wins STA Technology Award

01/25/2007
Irvine, California January 25, 2007 - Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that an independent study concluding that a preliminary Masimo engineering prototype can accurately measure total hemoglobin continuously and noninvasively has won the prestigious "Excellence in Technology Innovation" award at the 2007 Annual Meeting of the Society for Technology in Anesthesia (STA). In the study, conducted by M. R. Macknet, MD and a team of researchers at Loma Linda University's Department of Anesthesiology, an engineering prototype from Masimo designed to measure total hemoglobin noninvasively was compared to invasive laboratory CO-Oximetry in its ability to accurately measure total hemoglobin levels in 19 patients scheduled to undergo surgery and nine healthy volunteers undergoing a hemodilution protocol. After reviewing 458 data pairs collected from the 28 patients, researchers concluded that the Masimo technology accurately delivered total hemoglobin levels, with the study showing bias, precision and ARMS of -0.039, 1.09, and 1.09 respectively when compared to invasive laboratory CO-Oximetry.1 Researchers concluded, "This device is the first device developed that can continuously and non-invasively measure hemoglobin concentration in addition to the other common hemoglobin species, and therefore provides a significant expansion to existing physiologic monitoring technology." The same group of researchers from Loma Linda also presented a case study where the Masimo engineering prototype was used to track total hemoglobin during a liver and kidney transplant procedure. During the 16 hour procedure in which the Masimo device gave continuous readings, 17 blood samples were taken to correlate total hemoglobin levels. The researchers stated, "SpHb correlated well with CO-Oximeter determined Hb during most of this complicated procedure. Measurements showed good correlation during times of rapidly changing Hb concentration related to surgical blood loss and transfusion. Continuous and noninvasive hemoglobin monitoring would be an extremely useful tool in many clinical scenarios. This technology has the potential to greatly improve patient care and safety during surgical procedures."2 Masimo intends for this application to become part of the Rainbow SET platform. Masimo Rainbow SET is a platform which currently allows for the measurement of many blood constituents that have never before been measured noninvasively. Carboxyhemoglobin (SpCO) and methemoglobin (SpMet), as well as oxyhemoglobin (SpO2) that is accurate during motion and low perfusion, are currently commercially available to clinicians with Masimo Rainbow SET Radical-7. Extensive engineering and additional clinical research is currently underway to finalize the measurement of total hemoglobin with the plan to have SpHb ready for commercial use in 2007. Total hemoglobin content is one of the most frequently ordered lab tests and is critical to maintaining adequate oxygenation. A noninvasive method of quantifying total hemoglobin, oxygen saturation, methemoglobin and carboxyhemoglobin would speed diagnosis and proper treatment of patients. According to the Loma Linda research team, "rapid measurement of hemoglobin would be an extremely useful tool in many clinical scenarios. This technology (Masimo Rainbow SET) in combination with methemoglobin and carboxyhemoglobin measurements should allow for significant advances in patient care." Joe E. Kiani, Founder & CEO of Masimo stated, "This is the third time Masimo technology has won such a prestigious award from the Society of Technology in Anesthesia. In 1995, we won the Excellence in Technology Innovation award for the foundational technology of Masimo SET, the first pulse oximetry technology to provide accurate and reliable SpO2 measurements during motion and low peripheral perfusion. Last year Masimo Rainbow SET won the Application of Technology award for creating the first technology to provide noninvasive measurement of carboxyhemoglobin and methemoglobin levels in the blood, and this year we are honored with the Excellence in Technology Innovation award for our latest work on continuous and noninvasive hemoglobin monitoring." "We thank the STA for encouraging and supporting our zeal for innovation for the betterment of patient care. We also extend our gratitude and congratulations to both our engineering team, and the independent clinical researchers, such as Dr. Mark Macknet. Without their passion for helping patients, we could not accomplish anything", continued Mr. Kiani. About Masimo Masimo develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-Through Motion and Low Perfusion pulse oximetry, known as SET and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations-establishing the technology as the "gold standard" pulse oximetry and substantially contributing to improved patient outcomes. In 2005 Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Masimo, founded in 1989, has the mission of "Improving Patient Outcomes 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. 1 Continuous Non-Invasive Measurement of Hemoglobin via Pulse CO-oximetry. M. R. Macknet MD, S. Norton MD, P. Kimball-Jones MD, R. Applegate II MD, R. Martin MD, M. Allard M.B.Ch.B FRCA. Loma Linda University, Department of Anesthesiology 2 Continuous Non-Invasive Measurement of Hemoglobin via Pulse CO-oximetry During Liver Transplantation, a Case Report. M. R. Macknet MD, P. Kimball-Jones MD, R. Applegate II MD, R. Martin MD, M. Allard M.B.Ch.B FRCA. Loma Linda University, Department of Anesthesiology Contact: Tom McCall Masimo Corporation 949-297-7075 Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.

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