Masimo Achieves New Milestone—Ships One Millionth Oximeter

Milestone Event Celebrates Wellness and Commitment to Advancing the Standard-of-Care

Sep 29, 2011, 19:30 ET from Masimo Corporation

IRVINE, Calif., Sept. 29, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it shipped its 1,000,000th Masimo SET® pulse oximeter and rainbow® SET Pulse CO-Oximeter (excluding hand-held units).  The one millionth oximeter went to Sisters of Charity Hospital in Buffalo, New York, as part of a new NICU, Labor & Delivery and Nursery technology conversion.   To celebrate this milestone, Masimo held a Millionth Oximeter Celebration at its corporate headquarters in Irvine, California today.

(Photo:  http://photos.prnewswire.com/prnh/20110929/LA77902)

Joe Kiani, Founder, Chairman and CEO of Masimo, stated "We are excited to achieve this milestone and share the moment with the Sisters of Charity Hospital and our local community.  As the recipient of our millionth Masimo rainbow SET oximeter, Sisters of Charity Hospital joins an ever-growing list of premier hospitals that have chosen Masimo to provide the new standard-of-care in patient monitoring.  And, celebrating our millionth oximeter is a reminder of how our technologies have advanced patient care and improved patient safety for millions."

Founded with the goal of solving the 'unsolvable' problems plaguing patient care, Masimo innovations have revolutionized pulse oximetry and noninvasive blood constituent, hemodynamics, and respiration monitoring.  When conventional pulse oximetry technologies failed to measure accurately and reliably during patient motion and low perfusion and other companies could not solve the problem, Masimo succeeded with the invention of Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry technology.  When conventional pulse oximetry failed to measure accurately in the presence of dyshemoglobins (like carboxyhemoglobin and methemoglobin) and other pulse oximetry technologies could not isolate and measure dyshemoglobins, Masimo succeeded again.  With Masimo rainbow® SET Pulse CO-Oximetry™ clinicians can now continuously measure and monitor multiple blood constituents, dyshemoglobins, and physiological parameters that previously required invasive procedures.  And, thanks to Masimo Patient SafetyNet™, continuous patient monitoring on general care floors—where 80% of the hospital population is cared for—is now finally a reality at hospitals worldwide.    

"When we started Masimo, our mission was to 'improve patient outcome and reduce cost of care by taking noninvasive monitoring to new sites and applications.'  While we feel like we have just begun, I am proud that we have already accomplished every aspect of our mission," continued Joe Kiani.  

Today, Masimo medical breakthroughs and technology innovations allow more patients to be accurately and reliably monitored and are transforming lives in ways that were not possible with conventional pulse oximetry.  Spanning every care area and clinical setting, Masimo solutions are helping clinicians to improve patient safety and clinical outcomes by dramatically increasing the early detection of physiological abnormalities and life-threatening conditions, reducing retinopathy of prematurity (ROP), enabling the screening of congenital heart defects (CHD) in newborns, and decreasing risky blood transfusions in the operating room, as well as rescue events and costly ICU transfers on general care floors are just some of the ways Masimo is making a measureable difference for patients around the world.    

According to Antonio Garcia at Frost & Sullivan, "Masimo simply takes the guess work out of pulse oximetry, so clinicians never have to guess what brand is the most reliable.  Masimo's novel product portfolio has added a new dimension to noninvasive patient monitoring equipment that has considerably facilitated early detection of challenging patient conditions."

The superior performance and innovative capabilities of Masimo SET and rainbow SET technologies and products have produced more than 12 medical firsts, garnered over 60 industry awards, and fueled the growing adoption of Masimo at hospitals around the world.  In just four years, Masimo has doubled its 2007 milestone of 500,000 oximeters shipped on the heels of its 200,000th oximeter milestone, achieved in 2004. And, today more than half of the top hospitals listed on the U.S. News & World Report Best Hospitals Honor Roll have converted to Masimo technology.

Masimo SET has been clinically proven in over 100 independent studies to provide the most accurate and reliable SpO2 and pulse rate measurements, even under the most challenging conditions of patient motion and low peripheral perfusion. Utilizing patented signal processing technologies, including parallel engines and adaptive filters, Masimo SET delivers accurate and reliable measurements of a patient's true oxygenation status when conventional pulse oximetry technologies don't—reducing false patient monitor alarms by over 95% (sensitivity) and expanding true alarm detection to over 97% (specificity).(1)  Before Masimo SET, pulse oximetry was a fair weather friend—useful only under ideal conditions, but unreliable when accurate monitoring was needed most.  With Masimo SET, pulse oximetry is now not only a foul weather friend, but is being used in places and care areas it couldn't before. As a result, the industry has not only come to depend on continuous noninvasive physiologic monitoring by Masimo SET pulse oximetry, but has made it the leading Measure-Through Motion and Low Perfusion SpO2 solution incorporated into over 100 multiparameter monitors and 50 monitoring brands.

In addition, Masimo has taken noninvasive monitoring to new applications by bringing new noninvasive capabilities and solutions to the point-of-care that eliminate the pain, complexity, and delays associated with  invasive blood draws and procedures.  Masimo rainbow SET® Pulse CO-Oximetry™, a breakthrough technology platform featuring the accuracy and reliability of Masimo SET, is continuing to revolutionize patient monitoring by significantly expanding the ability to noninvasively capture, continuously track and monitor multiple blood constituents that previously required invasive procedures, including: total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), perfusion index (PI), and acoustic respiration rate (RRa™), in addition to the 'gold standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), and pulse rate (PR).

Over the Years, Leading Clinicians Have Recognized Masimo Innovations as Medical Breakthroughs

In 2002, Dr. Charles Durbin, Department of Anesthesiology, at the University of Virginia Health System in Charlottesville, Virginia, warned clinicians of the impact of conventional pulse oximetry on patient care and safety, stating that, "Monitors providing false alarms distract caregivers from other tasks and require attention to trouble shoot or fix the monitor. This decreases efficiency, increases costs, and increases the likelihood that monitoring will not be continued because of caregiver distrust of the device. Ultimately, patient safety may be adversely affected. This is particularly important because oximetry is being used outside the ICU on the general ward where the effects of false alarms are even more likely to negatively affect patient outcome. Recent studies on human error and patient safety point to caregiver cognitive overload and distraction (termed latent conditions) as one cause of patient injury or error."  In contrast to conventional oximetry, Dr. Durbin's research studies concluded that "Masimo SET pulse oximetry technology was more reliable and accurate than conventional pulse oximetry, has been shown to perform well in poor perfusion states and during motion, resulted in far less monitoring failure time than conventional oximetry, and presented more reliable oximetry data to clinicians, which resulted in 68% faster weaning of FI02 with 34% fewer arterial blood gas draws (ABGs)."(2)

In 2003, Dr. Augusta Sola, lead researcher and author of a breakthrough protocol to reduce ROP using Masimo SET pulse oximetry stated, "I tell my friends, my family, and my neighbors in America and overseas, a good thing happened in 1989—Masimo SET technology changed the way we can use pulse oximetry." Studies conducted at Cedars-Sinai Medical Center in Los Angeles showed that Masimo SET helped to reduce the rate of ROP from 12% to 2.5% and the need for ROP laser treatment from 4.5% to 0%.(3)

In 2005, Dr. Steven Barker, Head of the Department of Anesthesiology at the University of Arizona College of Medicine, commented that, "In the 25-year history of pulse oximetry, no one has produced an instrument that will function accurately on patients suffering from carbon monoxide poisoning.  The development of a pulse oximeter that can separately measure carboxyhemoglobin and oxyhemoglobin will be a major advance in healthcare...and would soon become a standard of care in emergency rooms, ambulances, and many other critical care settings."(4)

Numerous lifesaving accounts have highlighted the impact of noninvasive carboxyhemoglobin (SpCO) measurements from Masimo's handheld Rad-57, including one from Wake County EMS Chief, Skip Kirkwood, M.S., J.D., EMT-P, who said, "We believe that all 50+ hotel guests might have been dead at dawn if it were not for this lifesaving intervention from Masimo."

Masimo's First Customers are Still Ardent Supporters and Users of the Technology Almost 20 Years Later

One of Masimo's first installations was at Hannover Medical School in Hannover, Germany, where Prof. Christian F. Poets, M.D. was the Director of the Neonatal Intensive Care Unit (NICU) at the time.  Now the Medical Director for the Department of Neonatology at Tubingen University Hospital (Germany), Dr. Poets stated, "In my view, Masimo has revolutionized the continuous, noninvasive measurement of oxygenation by making it much more motion-resistant and capable of producing reliable measurements at low perfusion. This has been made possible by excellent engineering and their willingness to listen to their customers' needs."

Dr. Katsuyuki Miyasaka, Director of the Perioperative Center at St. Luke's International Hospital in Tokyo, Japan, is another one of Masimo's very first customers, responsible for the first hospital-wide installation of Masimo SET pulse oximeters at the National Center for Child Health and Development (Tokyo).  "When I first experienced using a Masimo SET pulse oximeter on a hyperkinetic infant in 1993, I was amazed and assured that Masimo SET would be the first-ever pulse oximeter to solve the problem of patient motion artifact and low perfusion.  Congratulations to Masimo for shipping one million pulse oximeters.  I am sure that SpHb and other emerging noninvasive innovations enabled by Masimo rainbow SET technology will further contribute to improved patient care and save even more patients' lives."

Peter U. Bergmann, FACHE, President and CEO of Sisters of Charity Hospital and one of Masimo's newest customers, stated, "We are honored to be the recipient hospital of Masimo's millionth oximeter. Converting the NICU, labor & delivery and nursery departments to Masimo SET provides us with the most advanced oximetry technology enabling the most advanced care for newborns. At Sisters of Charity Hospital, you can be confident that your baby is receiving the most advanced medical and nursing care available using state-of-the-art technology with a family-centered approach to care.  Our number one priority is to ensure that you and your baby receive the best care possible during your stay with us and Masimo oximeters are an important part of monitoring our tiniest patients."

(1) Shah N., Estanol L. "An Evaluation of Three New Generation Pulse Oximeters during Motion & Low Perfusion in Volunteers." Anesthesiology 2006; 102: S-75.

(2) Durbin C.G .Jr., Rostow S.K.  "More Reliable Oximetry Reduces the Frequency of Arterial Blood Gas Analyses and Hastens Oxygen Weaning after Cardiac Surgery: A Prospective, Randomized Trial of the Clinical Impact of a New Technology."  Crit Care Med. 2002 Aug;30(8):1735-40.

(3) Chow L.C., Wright K.W., Sola A.; CSMC Oxygen Administration Study Group. "Can Changes in Clinical Practice Decrease the Incidence of Severe Retinopathy of Prematurity in Very Low Birth Weight Infants?" Pediatrics. 2003 Feb;111(2):339-45.

(4) Barker S.J., Curry J., Redford D., Morgan S. "Measurement of Carboxyhemoglobin and Methemoglobin by Pulse CO-Oximetry: A Human Volunteer Study." Anesthesiology. 2006 Nov;105(5):892-7.

To see a summary of all known clinical studies and abstracts on Masimo technologies, please visit: http://www.masimo.com/cpub/clinicals.htm.

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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, 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).  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 noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices.  Masimo SET and Masimo rainbow SET technologies can be also 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.

About Sisters of Charity Hospital

Sisters of Charity Hospital was Buffalo's first hospital, with a tradition of superior care dating back to 1848.  Today, the hospital is part of the Catholic Health system that provides care to Western New Yorkers across a network of hospitalsprimary care centersimaging centers, and several other community ministries.  With 290 licensed beds, Sisters of Charity Hospital provides comprehensive medical care and treatment to more than 15,000 inpatients, 33,000 emergency room visitors, and 560,000 outpatients each year.

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 the superior performance of Masimo SET pulse oximetry and the clinical importance of the upgradeable Masimo rainbow® SET Pulse CO-Oximetry™ technology platform have contributed to the growth and adoption of Masimo technologies, risks related to our belief that Masimo technologies help hospitals to improve patient care and enhance patient safety initiatives , 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.

Media Contacts: Dana Banks Phone: (949) 297-7348 Email: dbanks@masimo.com

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.

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