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Masimo Announces TFA-1(TM) Transflectance Adhesive Forehead Sensor

IRVINE, CA -- (Marketwired) -- 06/25/14 -- Masimo (NASDAQ: MASI) today announced CE Mark of the new TFA-1 transflectance forehead adhesive sensor, offering clinicians the power of Masimo SET® Measure-through Motion and Low Perfusion™ Pulse Oximetry on an alternative monitoring site for rapid detection of oxygen saturation changes during low perfusion.

TFA-1 single-use sensors for adult and pediatric patients provide SpO2, pulse rate, perfusion index, and PVI® measurements.

TFA-1 sensors utilize Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology proven by more than 100 independent and objective studies and used on more than 100 million patients a year in leading hospitals worldwide, including eight of the top 10 on the U.S. News & World Report Best Hospitals Honor Roll (2013-2014). Masimo SET® significantly reduces false alarms (specificity), accurately detects true alarms (sensitivity), and provides measurements when other pulse oximeters fail.(2,3) Most importantly, the accuracy of Masimo SET® pulse oximetry in real-world conditions has been clinically proven to improve patient outcomes and reduce cost of care by helping clinicians:

  • Decrease retinopathy of prematurity (ROP) in neonates by avoiding giving too much oxygen based on inaccurate SpO2 measurements(4,5)
  • Increase detection of critical congenital heart disease (CCHD) in newborns by accurately identifying low SpO2 measurements(6,7)
  • Reduce ventilator weaning time by titrating FiO2 faster and reduce arterial blood gas measurements in the ICU through more reliable SpO2 measurements(8)
  • Decrease rapid response activations and ICU transfers to save lives and costs in post-surgical patients on the medical-surgical floors through earlier identification of patients in distress through low SpO2 and abnormal pulse rate measurements.(3,9)

"The TFA-1 transflectance forehead adhesive sensor offers clinicians yet another way to leverage the breakthrough measurement capability in Masimo SET® pulse oximetry," said Joe Kiani, founder and CEO of Masimo. "By continuing to take Masimo's breakthrough technologies to new sites and applications, we are helping improve patient outcomes and safety while reducing cost of care."

TFA-1 transflectance forehead adhesive sensor is CE marked and available for purchase in CE countries.

(1) Redford DT et al. Anesth Analg, 2004;98(2S):S-94.
(2) Shah N, Ragaswamy HB, Govindugari K, Estanol L "Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers" .J Clin Anesth. 2012 Aug;24(5):385-91.
(3) Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2. Available online here.
(4) Castillo A, et al. Acta Paediatr. 2011 Feb.;100(2):188-92.
(5) Bizzarro MJ, Li FY, Katz K, Shabanova V, Ehrenkranz RA, Bhandari V. Temporal quantification of oxygen saturation ranges: an effort to reduce hyperoxia in the neonatal intensive care unit. Journal of Perinatology (2014) 34, 33-38; doi:10.1038/jp.2013.122; published online 26 September 2013
(6) de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
(7) Ewer A, et al. Health Technol Assess. 2012;16(2):1-184.
(8) Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
(9) Anesthesia Patient Safety Foundation. APSF Newsletter. "No Patient Shall be Harmed by Opioid-Induced Respiratory Depression." 2011; 26(2):21-40. Available online here.

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 related to the new TFA-1 disposable transflectance forehead sensors, including our belief the sensors offer faster response to saturation changes compared to digit sensors during low perfusion, and our belief in the breakthrough ability of Masimo SET® pulse oximetry to measure-through motion and low perfusion; 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 are trademarks or registered trademarks of Masimo Corporation

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