SOURCE: Masimo

Masimo

May 02, 2014 08:02 ET

Masimo Celebrates 25th Anniversary of Its Incorporation With Major Initiatives to Improve Patient Safety

Actions Include Day of Volunteering, $2.5 Million Donation and New Clinically Significant Product Announcements

IRVINE, CA--(Marketwired - May 2, 2014) - Masimo (NASDAQ: MASI), the innovator of breakthrough patient monitoring technologies clinically shown to saves lives and the eyesight of newborns, and to help clinicians reduce unnecessary medical procedures and make better, faster decisions, today announced it will celebrate its Silver 25th Anniversary with major initiatives to improve patient safety.

Starting with a worldwide Day of Volunteering in the name of eliminating preventable patient deaths, teams of Masimo volunteers from across the globe will call on the world's acute-care hospitals to make public commitments to patient safety and report the measurable steps they have taken or will take to eliminate preventable patient deaths, aiding the Patient Safety Movement Foundation's goal of zero preventable deaths by 2020. The Day of Volunteering to eliminate preventable patient deaths is June 5, 2014.

More than 3 million preventable patient deaths occur each year worldwide, with more than 200,000 in U.S. hospitals.1 Masimo has been the presenting sponsor of the Patient Safety, Science & Technology Summit, which is the annual meeting of The Patient Safety Movement Foundation -- a nonprofit 501(c) founded by Joe Kiani and the Masimo Foundation for Ethics, Innovation and Competition in Healthcare -- dedicated to eliminating preventable patient deaths in U.S. hospitals by 2020.

Masimo volunteers seek to help the Patient Safety Movement Steering Committee enlist 1,000 hospitals. The hospitals that make public commitments will be announced at the third-annual Patient Safety, Science & Technology Summit in January 2015. At the conclusion of this year's Summit, the Patient Safety Movement announced that more than 60 hospitals and healthcare systems made commitments to help reduce preventable patient deaths, and at least one and 601 lives had been saved as a direct result of previous commitments.

As part of the 25th Anniversary, Masimo also announced the donation of $2.5 million to the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Foundation, founded in 2010, supports programs, initiatives, and research designed to improve patient safety and outcomes, promote efficient and cost-effective healthcare delivery, and provide advanced healthcare to people worldwide who may not otherwise have access to lifesaving technologies.

And in a long-planned move in anticipation of the 25th Anniversary, Masimo also will unveil at least one new clinically significant product a month for the remainder of this year, in an engineering push to accelerate innovative technologies that improve patient outcomes and safety, while reducing the cost of care.

These new products will build on the company's consumer product line, the Root® patient monitoring platform, and on revolutionary Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, the pioneering technology Masimo unveiled nearly two decades ago to solve the "unsolvable" problem of pulse oximetry's unreliability when it was needed most -- during patient motion and low perfusion -- as well as breakthrough rainbow® Pulse CO-Oximetry,™ allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), and methemoglobin (SpMet®).

"We are humbled and honored to celebrate 25 years of medical technology innovation with the help of our dedicated global team and the support of our valued clinical and OEM partners," said Joe Kiani, founder and CEO of Masimo. "People have described us over the years as the company that puts patients first, the company that solves the unsolvable, the company that is not afraid of taking a stand for what is right, the company that has endured David vs Goliath obstacles, and even the 'Masters of Light.' But nothing means more to us than each and every story we hear of how we have helped save or improve the lives of individual patients and their families. Through our Day of Volunteering, the donation to the Masimo Foundation, and a planned release of new clinically relevant medical products, we are re-setting the bar even higher to help improve patient outcomes, not just through innovation, but what we can do through a higher social calling and action."

The performance of Masimo SET® pulse oximetry is proven by more than 100 independent and objective studies and thousands of clinical evaluations. It is estimated that Masimo SET® helps clinicians monitor more than 100 million patients each year and is the primary pulse oximetry technology for eight of the top 10 hospitals on the U.S. News & World Report Best Hospitals Honor Roll (2013-2014).

Compared to other pulse oximeters, during patient motion and low perfusion, Masimo SET® provides measurements when other pulse oximeters cannot, dramatically reduces false alarms, and accurately detects true alarms2 that can indicate a deteriorating patient. ECRI Institute consistently ranks alarm management atop its annual Top 10 Technology Hazards list, noting that "caregivers can become overwhelmed trying to respond to the alarms, or they can become desensitized, which can lead to missed alarms or delayed response, placing patients at risk." Masimo SET® revolutionized pulse oximetry by reducing false alarms by 95% and improving the detection of true alarm conditions, not by long averaging or freezing, but by extracting the true signal in the presence of overwhelming noise.

Most importantly, Masimo SET® pulse oximetry has been shown to improve patient outcomes by enabling clinicians to reduce retinopathy of prematurity (ROP) in neonates,3 screen newborns for critical congenital heart disease (CCHD),4,5 reduce ventilator weaning time and arterial blood gas measurements in the ICU,6 and save lives and costs while reducing rapid response activations and intensive care unit transfers on the general floor.7

"Since its introduction, it is estimated that Masimo SET pulse oximetry has prevented at least 25,000 potential cases of severe ROP and blindness in newborns worldwide, and has saved hundreds of thousands of lives of patients of all ages," said Dr. Augusto Sola, Vice President of Medical Affairs for Neonatology at Masimo. "Additionally in the past few years, Masimo SET pulse oximetry has saved from death or severe morbidities a significant number of infants with congenital heart disease and the number will grow as SET Pulse Oximetry screening is implemented more widely."

Meanwhile, Masimo rainbow® technology has been shown to make a clinical difference by improving patient safety and reducing cost of care. Noninvasive and continuous total hemoglobin (SpHb®), for example, has been shown to help clinicians reduce both the frequency of often-unnecessary multi-unit red blood cell (RBC) transfusions and the average number of RBC units transfused, and in cases where transfusions are needed, to help clinicians initiate transfusions faster.8

The American Medical Association and The Joint Commission have identified RBC transfusions, which can lead to higher mortality and infection rates,9 as one of the top five overused procedures in medicine.10

Another major noninvasive monitoring advancement has been SpCO®, shown in many independent clinical studies to be an effective front-line assessment tool to help clinicians identify more potential carbon monoxide (CO) poisonings -- the leading cause of accidental poisoning deaths11 -- more quickly, enabling faster intervention to improve patient outcomes.12,13,14,15

Joe Kiani, Concluded: "None of Masimo's achievements would have been possible without early believers in the company's vision. Special gratitude goes to the engineers, investors, as well as legal, healthcare and industry professionals who helped propel Masimo. Although too numerous to list here, a few are: Ammar Al-Ali, Steve Barker, Jim Bergman, Abbas Bolandgray, Anne de Wahl Granelli, Mohamed Diab, Robert Feibusch, Mitch Goldstein, Steve Jensen, Mary Kiani, Jack Lasersohn, Katsuyuki Miyasaka, Christian Poets, Joe Re, Larry Saper, Jim Scopa, Augusto Sola, Bob Smith, and Walt Weber. We thank them immensely!" A more comprehensive roster will be available in Masimo's upcoming Annual Report and posted at www.masimo.com.

1 http://www.ncbi.nlm.nih.gov/pubmed/23860193
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 Castillo A, et al. Acta Paediatr. 2011 Feb.;100(2):188-92.
4 de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
5 Ewer A, et al. Health Technol Assess. 2012;16(2):1-184.
6 Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
7 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.
8 Wael NA, Mahmoued 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.
9 Marik PE.et.al. Crit Care Med. 2008;36(9):2667-74
10 Joint Commission Perspectives. The Joint Commission Continues to Study Overuse Issues. Volume 32, Number 5, 2012: 4-8(5).
11 Hampson N., Weaver L. "Carbon Monoxide Poisoning: A New Incidence for an Old Disease." Undersea Hyperb Med 2007;34:163-168.
12 Zorbalar N, Yesilaras M, Aksay E. "Carbon monoxide poisoning in patients presenting to the emergency department with a headache in winter months." Emerg Med J Published online ahead of print Oct. 15, 2013
13 Sebbane M, Claret PG, Mercier G, Lefebvre S, Thery R, Dumont R, et al. "Emergency Department Management of Suspected Carbon Monoxide Poisoning: Role of Pulse Co-Oximetry." Respir Care. Published online ahead of print Mar 19, 2013.
14 Suner S, Partridge R, Sucov A, et al. "Noninvasive Pulse CO-Oximetry Screening in the Emergency Department Identifies Occult Carbon Monoxide Toxicity." J. Emerg Med. 2008; 34(4): 441-450.
15 Hampson N. "Noninvasive pulse CO-oximetry expedites evaluation and management of patients with carbon monoxide poisoning." The American Journal of Emergency Medicine 2012 (10.1016/j.ajem.2012.03.026)

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 indepensdent 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 belief that Masimo SET provides real-time results for all patients to help clinicians to more rapidly assess, diagnose, and treat every patient; 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: continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; risks related to our belief that Masimo SpCO will provide an accurate and effective noninvasive method of screening for CO poisoning; risks related to our belief that SpCO offers an effective front-line assessment tool; 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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