Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin Monitor
Success in Limited Market Release Hospitals Highlights Early Clinical Benefits and Patient Impact
Irvine, California – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that it has initiated the full market release of its breakthrough noninvasive and continuous hemoglobin (SpHb™) monitoring technology. As the first noninvasive and continuous hemoglobin monitoring technology to receive FDA 510(k) clearance and be available for widespread commercial adoption, Masimo SpHb is already transforming the way hemoglobin testing is performed at over 40 hospitals in the U.S., Europe, Asia, and Africa, that have participated in the technology's limited market release initiated in September of 2008.
The availability of noninvasive, continuous, and immediate hemoglobin measurements is expected to have wide ranging clinical impact, from surgery and intensive care to less acute care settings, including the emergency department, physician office, ambulatory surgery center, and long-term care facility by facilitating prompt detection of internal bleeding and more appropriate administration of blood transfusions. Early benefits and impact of Masimo SpHb were evident in feedback received from clinicians at hospitals around the world who participated in the limited market release.
Ronald Miller, MD, Chief of Anesthesia, Professor and Chairman of the Dept. of Anesthesia and Perioperative Care at the University of California, San Francisco, stated, "Masimo SpHb is an impressive new tool that helps us to more safely guide patients in surgery through to recovery. With it, not only can we spot hemoglobin changes as they occur, but we can see where they are heading. This ability to identify an upward or downward hemoglobin trend on a second-by-second basis as it occurs has been of tremendous value."
Randy Marcel, MD, Medical Director and Chief of Anesthesiology at The Heart Hospital Baylor Plano in Plano, Texas, stated, "In the past, we've only received glimpses of our patients' hemoglobin levels from lab measurements, but now we have complete and real-time hemoglobin visibility. We initially purchased SpHb for use during cardiac surgeries in the OR, and brought in additional units for the ICU, where post-operative monitoring of internal bleeding is critical to patient recovery."
Javed Akhtar, MD, FAAP, Medical Director, Pediatric Intensive Care Unit at Creighton University Medical Center in Omaha, Nebraska, stated, "We purchased the SpHb monitor after seeing it in a hands-on demonstration, and I'm glad we did! SpHb has reduced the traumatic experience for pediatric patients, increased the satisfaction of parents, and reduced the workload on our nursing staff, phlebotomist and laboratory personnel."
Madhava Karunarathna, MD, OB/GYN at Balangoda Hospital in Sri Lanka, stated, "With SpHb, we now have accurate hemoglobin measurements available at our fingertips, around the clock. In cases of severe hemorrhaging during and after childbirth, SpHb has enabled us to immediately identify and continuously assess blood loss severity to better manage internal bleeding, prevent overloading of fluid, and decrease maternal death."
Adi Abdussalam Adham, MD, Chief Manager at Accidents Hospital Abu Saleem in Tripoli, Libya reinforced Dr. Karunarathna's comments, adding that: "In the operating room, Masimo SpHb has enabled us to more effectively monitor blood loss and better manage transfusions in surgery, while routine screening in the ED has helped us to more rapidly identify patients with anemia or internal bleeding."
Bertrand Debaene, MD, Anesthesiologist at the University Hospital Center of Poitiers in Poitiers, France believes the combination of SpHb and PVI may prove to have significant clinical benefits, saying that "SpHb, along with PVI, have been important improvements for both the department and our patients. The ability to track hemoglobin and fluid volume in real-time allows us to be more precise in our clinical routine."
SpHb is part of the Masimo Rainbow SET Pulse CO-Oximetry patient monitoring platform—the first-and-only upgradable technology platform capable of continuously and noninvasively measuring multiple blood constituents and helping to predict fluid responsiveness in patients previously requiring invasive procedures. Masimo Rainbow SET noninvasive measurements—including: total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI™, oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI)—have the potential to facilitate faster, easier and safer health decisions.
Currently available in bedside Masimo Radical-7® and Rad-87® Pulse CO-Oximeter patient monitors, SpHb will also be offered in handheld monitors and select multiparameter patient monitoring brands through Masimo Rainbow SET Pulse CO-Oximetry technology license agreements.
Joe Kiani, Founder and CEO of Masimo said, "SpHb's success during the limited market release phase at hospitals around the world illustrates its expected significant impact on clinical practice and patient care. In addition and as we expected, our limited market release program provided us with the opportunity to enhance the robustness in low perfusion situations and broaden the cross section of individuals on which the technology performs. The ability for clinicians in hospitals, private practices, and other healthcare settings to perform immediate and continuous noninvasive hemoglobin monitoring creates new opportunities to save lives, optimize decision making, improve care, and reduce costs."
SpHb has received regulatory clearance in the U.S., Canada, Europe and Australia, and is now available for sale in most of the countries in the world.
Masimo (NASDAQ: MASI) develops innovative 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 Masimo Rainbow SET® Pulse CO-Oximetry™, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI™, in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo 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.
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 the commercial availability of SpHb technology and products will serve to increase adoption, market share and/or revenues for the company, risks that limited market release clinical results may not be duplicated in the full market launch, risks related to our assumption that SpHb technology and products will provide faster, easier and safer means for measuring total hemoglobin and will lead to additional device sales, and risks related to our assumptions that Rainbow measurements will deliver a sufficient level of clinical improvement over alternative capabilities to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended January 3, 2009, filed with the Securities and Exchange Commission ("SEC") on March 4, 2009, 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 forward-looking statements or the "Risk Factors" contained in our Annual Report on Form 10-K for the fiscal year ended January 3, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.