Masimo Announces International Availability of Pronto-7™-a Palm-sized Spot-Check Device for Noninvasive Total Hemoglobin Measurement

IRVINE, California, August 8, 2011 /PRNewswire/ --

Masimo (NASDAQ: MASI) today announced CE Mark clearance for the international release of the Masimo Pronto-7®-a palm-sized handheld device designed for quick and easy noninvasive spot-checking of total hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index.  New features and product enhancements include the addition of Max Sensitivity Mode and expanded sensor size options to accommodate a wider range of finger sizes.

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New Features Improve Performance & Range of Testing

Several new features are now available and were designed to enhance performance. A Max Sensitivity Mode has been added that allows measurement over a broader range of patients.  In addition, the Pronto-7 now offers three noninvasive sensor sizes to accommodate the range of finger diameters.  Each sensor is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White).  Lastly, the new sensors are optimized to improve performance in low ambient temperatures.

Hemoglobin is one of the most commonly ordered tests in both hospital and non-hospital settings because it is critical to assessing blood loss. However, traditional lab testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results. The Pronto-7 offers a breakthrough solution for measuring hemoglobin in less than one minute-without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests.  With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1" x 2.8" x 1") and weight of 296 grams (10.5 ounces), the palm-sized Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, pulse rate, and perfusion index, into any clinician's hands in various clinical settings, including physician offices, hospitals, clinics, and on the scene of medical emergencies.  Because of the device's embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled and future upgrades will allow for wireless transmission to electronic health record (EHR) systems.

Dr. Ignacio Zuazua, Head of the Transfusion Department at the Hospital de Cruces in Barakaldo, Spain, who recently acquired Pronto-7 stated, "Pronto-7's noninvasive technology is helping blood donors avoid pre-donation needle sticks and allow department staff to reduce biological sample orders, cross contamination risks, and eliminate biohazard waste as no blood residues are generated during this noninvasive test."

"I am pleased to be using the Pronto-7 as it is a noninvasive and accurate device/solution," stated Dr. Eliane Petitpas, Anesthesiologist at Clinique Ste Isabelle in France. "I am using it mainly in the obstetrical environment where this measurement should lead to an enhanced security for the patient and our medical staff finds that the Pronto-7 is also very easy to use and practical."

"The Pronto-7 is the answer I have been looking for and dreaming of to enable us to test the haemoglobin of the children in our care without hurting them," said Sister Maureen Yunus, RN, Head Nurse at Sabah Women's & Children's Hospital in Malaysia.  "At the same time, the Pronto-7 will encourage children to get the test because it is noninvasive and painless."

According to Mark Ansermino, MD, Director of Pediatric Anesthesia Research at British Columbia's Children's Hospital: "The ability to screen children for anemia prior to surgery without the need to draw blood would increase the rate of screening and reduce the stress of this procedure for children and their families. I could see this as a routine procedure performed on every child before surgery. The potential global impact is even more important. A spot check of children for anemia would identify children with infective diseases such as malaria and tuberculosis but also screen for nutritional deficiencies and abnormal variants of hemoglobin such as sickle cell disease and thalassemia."

Prior to the introduction of the Pronto-7, Masimo received U.S. FDA 510(k) and CE mark clearance and first introduced the ability to noninvasively and continuously measure total hemoglobin (SpHb) in 2008 using its Radical-7 bedside Pulse CO-Oximeter.  In 2009, Masimo launched Pronto®-its first handheld noninvasive hemoglobin spot-check device for point-of-care hemoglobin testing-worldwide.  And in 2010, Masimo established Medicare reimbursement for transcutaneous hemoglobin measurement in the United States.  The international availability of the Pronto-7 device and new finger sensor sizes will enable clinicians throughout Europe, Middle East, Africa, and Australia to quickly and conveniently measure hemoglobin, SpO2, perfusion index, and pulse rate without removing a drop of blood.

Masimo Founder and CEO, Joe Kiani, stated: "The potential impact of noninvasive hemoglobin spot-check measurements offers healthcare providers around the world the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients. We believe that Pronto-7's latest features and enhancements will help clinicians to better assess more patients and make better clinical decisions based on the availability of quick and noninvasive hemoglobin measurement."

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 http://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 of the repeatability of clinical results obtained using the enhanced Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, 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 http://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: +1-949-297-7348
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.