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New Studies Presented at European Society of Anaesthesia Further Validate Masimo PVI™ for Noninvasive and Continuous Fluid Monitoring Irvine, California – June 12, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that three new independent studies demonstrating the clinical accuracy and utility of Masimo PVI as a noninvasive and continuous measure of patient fluid status and responsiveness were presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Milan, Italy. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality. Traditional invasive measurements such as central venous pressure are not reliable to predict whether a patient will benefit from fluid administration, and newer more reliable methods to predict fluid responsiveness are also invasive and costly. Multiple recent studies have shown that Masimo PVI provides a simple and cost-effective method for accurate, noninvasive, and continuous monitoring of fluid responsiveness. The three studies presented at the ESA reinforce the accuracy of PVI compared to invasive measures and highlight its value for before, during, and after anesthesia. Does the Pleth Variability Index correlate with stroke volume variation? The Change of Upper Limbs PVI in Spinal Block (Comparison in High Spinal Block and Non-High Spinal Block) Perfusion Index and Pleth Variability Index After Administration of General Anesthetic Agents Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated; "These studies confirm what previous results have shown—that PVI's accuracy at predicting fluid responsiveness is better than traditional measurements and similar to the newer invasive monitoring techniques at fraction of the cost and complexity. Because PVI is noninvasive and is available from the same sensor used with Masimo Rainbow SET® Pulse CO-Oximeters, it has the strong potential to expand and improve fluid monitoring and management in patients who would otherwise not be monitored with the newer invasive techniques." PVI is available as part of Masimo Rainbow SET Pulse CO-Oximetry™—the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: noninvasive and continuous total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI, in addition to the 'gold standard' Measure-Through Motion and Low-Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI). 1 Y. Kawashima, Y. Shiraishi, S. Sato. Does the Pleth Variability Index correlate with stroke volume variation?. Eur J Anaesthesiol 2009; 26 (Suppl 45): 3AP5-9 About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Flo Trac is a registered trademark of Edwards Lifesciences.
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Masimo Debuts New Rad-8® Pulse Oximeter to Largest Gathering of Sleep Specialists from Around the World at SLEEP 2009 New Features and Design Optimize Care and Process Efficiencies for Clinicians in both the Sleep Center and Homecare Environments Irvine, California – June 9, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today the debut of its new compact, lightweight Rad-8 pulse oximeter at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies (APSS), June 6-11, 2009 in Seattle, Washington. Newly redesigned with greater clinical efficiency in mind, the new Masimo Rad-8 has a streamlined look and a host of easy-to-use special features that enable sleep clinicians to more effectively and efficiently monitor, diagnose, and care for patients with sleep disorders. Pulse oximetry is the standard method for assessing oxygenation in sleep testing and, as such, plays a critical role in treatment decisions, including whether to administer Continuous Positive Airway Pressure (CPAP) therapy or perform surgery. Inaccurate pulse oximetry data can have serious implications because false pulse oximetry desaturations can lead to misdiagnosis and inappropriate treatment or surgery, while missed true desaturations can prevent correct diagnosis and potentially lifesaving treatment. The new Rad-8 combines the unmatched sensitivity and specificity of Masimo SET® Measure-Through Motion and Low-Perfusion pulse oximetry—clinically-proven to reduce false alarms by over 90% and increase capture of true desaturation events by 98%—with enhanced functionality to help clinicians better capture, analyze, and report vital oxygen saturation, pulse rate, and perfusion data for improved sleep disorder detection. The superior fidelity of Masimo SET has been clinically-shown to outperform other pulse oximeters in the accurate identification and quantification of brief dips in oxygen saturation due to apneas and hypopneas—an important marker and measure of severity for Obstructive Sleep Apnea (OSA) diagnosis and treatment. In fact, previous research conducted at Montreal Children's Hospital in Quebec found that using a Masimo pulse oximeter with very short averaging time was not only more accurate in detecting true desaturation events, including brief dips in oxygen saturation as well as larger ones, but could also "significantly reduce workload and improve reliability of desaturation detection" over other pulse oximeters. Study findings confirmed that Masimo detected 98.6% of true desaturations, while the N-395 detected only 45.3%, leading researchers to conclude that "the sensitivity and motion artifact rejection characteristics of the Nellcor N-395 oximeter are not adequate for a pediatric sleep laboratory setting."2 1 National Institutes of Health "Frontiers of Knowledge in Sleep and Sleep Disorders: Opportunities for Improving Health and Quality of Life." March 2004. http://www.nhlbi.nih.gov/about/ncsdr/research/research-a.htm About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After Surgery Studies Advocate Blood Conservation and Appropriate Indicators for Transfusion Irvine, California – June 8, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that two new studies - one conducted in patients undergoing general surgery and published in the Journal of American College of Surgeons and another conducted in patients undergoing cardiac surgery and published in the Anesthesia & Analgesia- provide additional new evidence that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery.1,2 These studies suggest that transfusions and their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions. Blood transfusions may be necessary to ensure survival when a patient is bleeding heavily or has severe symptomatic anemia. However, transfusions are also given in the presence of stable anemia or when significant blood loss is expected but does not occur. These two new studies add to the growing evidence that transfusions carry life-threatening risks and urge that in the absence of benefit from transfusion, avoidance of transfusions through the use of more restrictive transfusion practices could improve patient outcomes. In the general surgery study, researchers evaluated 125,177 patients from 121 hospitals and showed that after adjusting for all risk variables, transfusion of a single unit of blood increased 30-day mortality by 32% and morbidity (pneumonia, sepsis, or surgical site infection) by 23%. Transfusion of two units of blood increased the mortality risk by 38% and morbidity risk by 40%. In the cardiac surgery study, researchers evaluated long-term survival of 9,079 patients at eight hospitals and showed that transfusion of one or two units of blood increased six-month mortality 67% and five-year mortality 16% . "These two new studies demonstrate that the risk of blood transfusion is significant and thus we should avoid transfusions when ever possible," stated Dr. Aryeh Shander, Clinical Professor of Anesthesiology, Medicine and Surgery at Mt. Sinai School of Medicine in New York, NY. "The current practice of using intermittent, invasive measurements of hemoglobin to help guide transfusion decisions may contribute to unnecessary blood transfusions. Blood transfusion should not simply be based on any particular level of hemoglobin but rather a thorough evaluation of the patient, including whether hemoglobin levels are stable or changing. The ability to continuously and noninvasively trend a patient's hemoglobin level offers a breakthrough in blood management. Continuous and noninvasive SpHb™ monitoring has the potential to greatly improve clinical decision-making and reduce patient exposure to allogeneic transfusion, reduce complications, and preserve a precious resource and costs." Masimo continuous and noninvasive hemoglobin monitoring (SpHb) technology is available as part of the upgradeable Masimo Rainbow SET® Pulse CO-Oximetry platform. 1 Bernard AC et al. Intraoperative transfusion of 1U to 2U of packed red blood cells is associated with increased 30-day mortality, surgical site infection, pneumonia, and sepsis in general surgery patients. Journal of the American College of Surgeons. 2009;208:931-937. About Masimo Forward Looking Statements Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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Leading University Hospital Completes System-wide Conversion to Masimo SET® Pulse Oximetry Standardizing on Masimo SET Allows Clinicians to Overcome the Limitations of Conventional Pulse Oximetry, Offering Significant Clinical Advancements Irvine, California—June 3, 2009 – Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion Pulse Oximetry, today announced it has completed the conversion of Duke University Hospital to Masimo SET pulse oximetry technology. "Ultimately, the decision to convert to Masimo SET came down to what was best for patients," said Tony Caruso, Senior Director of Clinical Engineering, Duke University Health System in Durham, North Carolina. "It is critically important for us to access technologies that result in improvements in patient care. In this case, we believe we have improved our ability to increase detection of true clinical events earlier." "In the emergency department, there are many times when we don't have time to second-guess our pulse oximeter performance, wonder whether the measurements we are getting are accurate, or take excessive time to obtain a reading," said Frank DeMarco, RN, emergency department clinical operations director, Duke University Hospital. "This technology offers us improvements over the system we had used previously and, hopefully, will contribute to more effective clinical operations." Masimo Founder and CEO, Joe E. Kiani, stated, "We are happy to be the pulse oximetry standard-of-care solution chosen by the Duke University Hospital system to noninvasively and continuously monitor their patients. With the unprecedented accuracy and performance of Masimo SET, clinicians at Duke are afforded the opportunity to better monitor, manage and treat patients using advanced pulse oximetry capabilities that allow them to detect life-threatening events earlier." About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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New NIH-Funded Study Shows Masimo Rainbow SET® May Help Clinicians Assess Oxygenation in Children with Sickle Cell Disease Study Presented at the American Thoracic Society by Researchers at The Children's Hospital of Philadelphia Confirms Accuracy and Clinical Value of Noninvasive SpCO® and SpMet® Irvine, California – May 19, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new independent clinical study, funded by the National Institutes of Health (NIH) and presented at the American Thoracic Society in San Diego, CA, shows that the noninvasive measurement of carboxyhemoglobin (SpCO) and methemoglobin (SpMet) with Masimo Rainbow SET Pulse CO-Oximetry is accurate and may help clinicians better detect hypoxemia—a potentially life-threatening lack of oxygen in the blood—in children with sickle cell disease. Sickle cell disease is an inherited blood disorder characterized by abnormally-shaped red blood cells that compromise vital blood and oxygen supply to the tissues and organs, causing life-threatening complications. The presence of carboxyhemoglobin and methemoglobin in a sickle cell patient's blood reduces oxygen supply further because these dyshemoglobins that take the place of normal oxyhemoglobin lack the ability to carry any oxygen. However, conventional two-wavelength pulse oximeters are incapable of measuring carboxyhemoglobin and methemoglobin levels and as a result cannot provide clinicians with an accurate picture of their patients' true oxygenation status in the presence of dyshemoglobins. Masimo Rainbow SET—the first-and-only technology that noninvasively and continuously measures SpCO and SpMet, in addition to total hemoglobin (SpHb™), oxygen content (SpOC™), PVI, oxyhemoglobin (SpO2), pulse rate, and PI—allows for faster and more accurate assessment of the patient's true oxygenation, which may help to advance the care and management of patients with sickle cell disease. In the study presented, Dr. Caboot and colleagues at Children's Hospital of Philadelphia simultaneously compared SpCO and SpMet measurements obtained noninvasively using the Masimo Radical-7 Pulse CO-Oximeter with invasive blood draws and laboratory analysis of carboxyhemoglobin and methemoglobin in 38 asymptomatic children (2-18 years of age) with sickle cell disease. The researchers found SpCO (with a bias of 0.1% and precision of ± 2.2%) and SpMet (with a bias of -0.19% and precision of ± 0.39%) to be closely comparable to invasive laboratory measurements. Researchers concluded that the Masimo Radical-7 Pulse CO-Oximeter "is useful in measuring carboxyhemoglobin and methemoglobin levels in pediatric patients with sickle cell disease." Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly, stated, "This research not only reinforces the clinical accuracy of SpCO and SpMet in assessing the true oxygenation of patients, but also highlights the importance of measuring these dyshemoglobins while managing and treating pediatric patients with sickle cell disease." Caboot, J.B., Jawad, A.F., McDonough, J.M., Bowdre, C.Y., Ohene-Frempong, K., Smith-Whitley, K., Allen, J.L. "Non-Invasive Measurements of Carboxyhemoglobin and Methemoglobin in Pediatric Patients with Sickle Cell Disease." Am. J. Respir. Crit. Care Med., Apr 2009; 179: A4788. Presented at the American Thoracic Society (ATS) Annual Meeting, May 19, 2009, San Diego, California. http://www.abstracts2view.com/ats09/view.php?nu=ATS09L_2057 Editor's Note: The study abstract available online depicts study data and results at the time of the "call for abstracts" submission deadline, although the study was on-going and continued beyond the submission date. The data and results captured in this press release represent the updated, final study data and results presented at the ATS International Conference on May 19, 2009. About Masimo Forward Looking Statements Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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New Study Funded by the National Institutes of Health (NIH) Finds Masimo SpCO® May Provide a Noninvasive Measure of Acute Asthma Severity in Children Study Presented at the Pediatric Academic Societies Annual Meeting by Vanderbilt University Researchers Shows a Statistically-Significant Association between SpCO and Measures of Lung Function Irvine, California – May 13, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new clinical study conducted in the Emergency Department at Vanderbilt Children's Hospital shows that the noninvasive measurement of carbon monoxide in the blood with Masimo Rainbow SET® Pulse CO-Oximetry (SpCO) may help clinicians better assess acute asthma severity during and after treatment. The study was funded by the National Institutes of Health (NIH) and presented at the Pediatric Academic Societies (PAS) Annual Meeting on May 5, 2009.1 Asthma is a life-threatening inflammatory disease of the airways that affects more than 6 million children in the U.S., leading to more pediatric hospitalizations than any other cause.2 However, a common challenge for children with asthma is the requirement of a forced expiratory test called spirometry. In contrast to spirometry, SpCO—a noninvasive measurement easily obtained from Masimo Rainbow SET Pulse CO-Oximeters and sensors already used in many hospitals—does not require patient instruction or breathing effort. As a result, SpCO may help to improve the assessment of asthma severity and response to treatment in young children and patients who are unconscious, heavily sedated, unable to understand and follow instructions, or have limitations that would interfere with vigorous respiratory efforts. "We have limited measures to assess severity of acute asthma exacerbations and the finding of an association between carboxyhemoglobin (SpCO) by multi-wavelength Pulse CO-Oximeter may have clinical importance," stated Donald H. Arnold, MD, MPH, Associate Professor of Emergency Medicine and Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee. "Our preliminary results suggest that SpCO is a measure of oxidative stress and inflammation in pediatric patients with acute asthma exacerbations." Dr. Arnold and colleagues at Vanderbilt used the Masimo Radical-7 Pulse CO-Oximeter to measure SpCO in 139 children (5-10 years of age) during acute asthma exacerbations and 2-hours after initiation of corticosteroid and bronchodilator treatment. Comparing SpCO measurements to conventional measures of airway obstruction and inflammation, researchers found a significant association between SpCO and percent predicted Forced Expiratory Volume in 1 Second (%FEV1, p = 0.001) and airway resistance (p = 0.04), as well as a trend with exhaled nitric oxide (eNO, p = 0.1). Study findings showed that for every 6% increase in SpCO, there was an associated 79% proportionate decrease in lung function (%FEV1, p=0.015) and a trend indicating SpCO may predict lung function after 2-hours of treatment, as measured by the change in %FEV1 (p = 0.06). Researchers concluded that SpCO may "represent a noninvasive, effort-independent measure of acute asthma disease severity as assessed by physiologic measures." Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly, stated, "This study adds new evidence that expands the value of Masimo's Pulse CO-Oximetry SpCO measurement. The researchers at Vanderbilt Children's Hospital have shown that the ability to easily and quickly perform SpCO measurements on almost any patient without cooperation or risk has the potential to enable more immediate, accurate, and reliable asthma severity assessment." 1 D. H. Arnold, T. Gebretsadik, D. Resha, T. V. Hartert. "Association of Carboxyhemoglobin Levels with Clinical Measures of Acute Asthma Severity." Presented at the Pediatric Academic Societies (PAS) Annual Meeting, May 5, 2009, Baltimore, Maryland. http://www.abstracts2view.com/pas/view.php?nu=PAS09L1_3201 Editor's Note: The study abstract available online via the PAS website depicts study data and results at the time of the "call for abstracts" and submission deadline (late 2008), although the study was on-going and continued beyond the submission deadline. The data and results captured in this press release represent the actual study data and results presented at the PAS Annual Meeting on May 5, 2009. About Masimo Forward Looking Statements Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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Masimo to Present at the Deutsche Bank 34th Annual Health Care Conference IRVINE, Calif., May 12, 2009 – Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced that its management is scheduled to present at the Deutsche Bank 34th Annual Health Care Conference in Boston, Massachusetts, on Tuesday, May 19, 2009, at 2:35 p.m. EDT. A live audiocast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the audiocast will be available following the live presentation. About Masimo Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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Masimo Reports First Quarter 2009 Financial Results Q1 2009 Highlights:
Irvine, California, May 5, 2009 – Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced its financial results for the first quarter of 2009. For the first quarter of 2009, Masimo reported product revenues of $74.5 million representing a 24.7% increase over $59.7 million for the first quarter of 2008. Including royalty revenues, Masimo reported total 2009 first quarter revenues of $85.5 million compared to $71.1 million for the first quarter of 2008. For the first quarter of 2009, Masimo reported earnings per share of $0.22 compared to $0.15 per common share for the first quarter of 2008. Masimo reported that it shipped 27,700 Masimo SET and Masimo Rainbow SET oximetry units, excluding handheld units, during the first quarter of 2009, resulting in at least 587,000 of Masimo SET and Masimo Rainbow SET pulse oximeters in use worldwide. In the first quarter of 2009, revenues from Masimo Rainbow SET products increased to $3.1 million from $2.7 million in the same prior year quarter. Joe E. Kiani, Chairman and Chief Executive Officer of Masimo, said, "Despite the continuing difficult economic environment, we are happy that our revenues and earning were better than we had expected in Q1. We believe that this performance is largely due to our gold standard Masimo SET pulse oximetry technology and our expanding Masimo Rainbow SET Pulse CO-Oximetry platform, including the March 23, 2009 commercial release of total hemoglobin, the world's first continuous non-invasive total hemoglobin monitor." Masimo also reported that as of April 4, 2009, cash and cash equivalents totaled $152.2 million, up from $146.9 million at January 3, 2009. Conference Call About Masimo Forward-Looking Statements Masimo Corporation Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpCO, SpMet, PVI, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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FEMA Adds Masimo Rad-57® Pulse CO-Oximeter™ to Required Medical Equipment List Citing Need for Early and Accurate Carbon Monoxide Exposure Detection Following Disasters, Agency Unanimously Approves and Authorizes Funds to Purchase Rad-57's Irvine, California – April 28, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that the Masimo Rad-57 Pulse CO-Oximeter has been added to the Federal Emergency Management Agency's (FEMA) list of required health and safety equipment for all Urban Search & Rescue (US&R) task forces throughout the United States. FEMA authorizes funding for each of its US&R task forces to purchase multiple Rad-57's, enabling them to quickly, accurately and noninvasively detect carbon monoxide (CO) poisoning on the scene of disaster recovery operations. FEMA has 28 national US&R task forces staffed and equipped to conduct round-the-clock search and rescue operations following earthquakes, tornadoes, floods, hurricanes, aircraft accidents, hazardous materials spills, and catastrophic structure collapses. Search and rescue operations often function in confined or poorly ventilated spaces with gas-powered equipment producing elevated levels of CO, which until now had been an overlooked hazard. Adding the Rad-57 to its mandatory medical equipment cache now allows FEMA's US&R task forces to quickly, noninvasively evaluate and address the significant health and safety risks associated with CO poisoning for both civilians and rescue personnel in the urban search and rescue environment—helping to save and sustain lives, minimize suffering and enhance safety. "Early and accurate CO exposure detection is important for successful mitigation and treatment of carbon monoxide poisoning," stated Neil Hampson, MD, Medical Director, Center for Hyperbaric Medicine at the Virginia Mason Medical Center in Seattle, Washington. "The Rad-57 will allow FEMA's US&R teams to swiftly, thoroughly and easily assess and diagnose CO poisoning to increase their public safety efforts in the urban search and response environment." According to the Centers for Disease Control and Prevention (CDC), carbon monoxide—a common, yet lethal poison produced whenever any carbon-based fuel, such as gas, oil, kerosene, wood, or charcoal is burned—presents a significant two-fold risk during a disaster when "chemicals are most commonly released from businesses and industries, storage tanks, agricultural facilities and homes," and "when power outages occur, the use of alternative sources of fuel or electricity cause CO to build up." The most common symptoms of CO poisoning are headache, dizziness, weakness, nausea, vomiting, chest pain, and confusion, while high levels of CO inhalation can cause loss of consciousness and death. Unless suspected, CO poisoning can be difficult to diagnose because the symptoms mimic other illnesses. Joe Kiani, Founder and CEO of Masimo, stated, "When elevated CO levels are present, disaster often strikes a second time, placing victims and their brave, unsuspecting rescuers in grave jeopardy. This is now a preventable disaster for rescuers and victims alike with Masimo Rad-57 in action on the front lines of U.S. disaster search and rescue efforts." About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners. NOTE TO REPORTERS AND EDITORS:
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Capgemini Releases New Study on Financial Impact of Masimo Noninvasive and Continuous Hemoglobin (SpHb™) Hospital-wide Implementation of Masimo Rainbow SET® Pulse CO-Oximetry™ Could Generate Nearly $500,000 in Net Annual Cost Savings and Financial Gains Irvine, California – April 16, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that Capgemini, a leading supplier of global consulting and technology services, has released a study showing that a typical 500 bed hospital incorporating Masimo Rainbow SET Pulse CO-Oximetry into its clinical standards and care pathways could generate nearly $500,000 in net annual cost savings and financial gains. Capgemini reported that significant financial benefits could be derived from incorporating noninvasive total hemoglobin (SpHb) by helping clinicians prevent unnecessary blood transfusions, identify internal bleeding earlier, and increase patient throughput. The study concluded that "whether considered on a per-patient, department, or hospital-wide analysis, there are significant clinical and financial benefits to implementing Pulse CO-Oximetry technology." Masimo commissioned the Capgemini study for a third-party evaluation of the potential financial benefits of Masimo Rainbow SET. Hospital inputs were evaluated by Capgemini through 70 in-depth one-on-one interviews with clinicians and other decision-makers at 15 U.S. acute care hospitals and then quantified through a follow-on survey of 200 hospital-based physicians. The study found that the majority of anesthesiologists and two-thirds of surgeons believed that SpHb monitoring could prevent at least one unnecessary blood transfusion in every ten surgical cases on which it was used, contributing to $93,600 in net annual cost savings in a surgical department using 20 SpHb-enabled devices. The study also found that the majority of intensivists believed that SpHb monitoring could reduce intensive care length of stay by at least one day for every 15 or fewer patients on which it was used, contributing to $67,350 in net annual cost savings in an intensive care department using 10 SpHb-enabled devices. Joe Kiani, Founder and CEO of Masimo, stated, "We believe that the Capgemini study will significantly aid hospitals seeking to evaluate the initial and ongoing investment in Masimo Rainbow SET by clearly identifying each of the various mechanisms by which SpHb can improve the clinical process of care and create net financial benefits." The Capgemini study can be downloaded at www.masimo.com/capgemini. In addition, a customized financial analysis based on a hospital's own inputs incorporated into the Capgemini financial model is available upon request. About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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Masimo to Report First Quarter 2009 Financial Results on May 5, 2009 Conference call and webcast to begin after markets close at 2:00 p.m. PT (5:00 p.m. ET) Irvine, Calif., April 14, 2009—Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced it will release first quarter 2009 financial results for the period ended April 4, 2009 after the market closes on Tuesday, May 5, 2009. A conference call to review the results will begin at 2:00 p.m. PT (5:00 p.m. ET) and will be hosted by Joe E. Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer. A live webcast of the conference call will be available online from the investor relations page of the Company's corporate web site at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 679-9937 for international callers. The reservation number for both dial-in numbers is 95073118. After the live webcast, the call will remain available on Masimo's website through June 5, 2009. In addition, a telephonic replay of the call will be available through May 19, 2009. The replay dial-in numbers are (800) 642-1687 for domestic callers and +1 (706) 645-9291 for international callers. Please use reservation code 95073118. About Masimo Masimo Corporation Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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New Clinical Study Shows Masimo PVI™ Accurately Predicts Fluid Responsiveness in the ICU First Study to Expand PVI Utility Beyond the OR Presented at the 29th International Symposium on Intensive Care and Emergency Medicine in Brussels Irvine, California – March 31, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new independent clinical study demonstrates Masimo PVI to be an "accurate index of fluid responsiveness" for critical care patients in the intensive care unit (ICU).1 The study, presented at the 29th International Symposium on Intensive Care and Emergency Medicine on March 25, 2009, in Brussels, Belgium, is the first to show the potential value of Masimo PVI to predict fluid responsiveness beyond the operating room (OR) into the ICU. Critically-ill patients are at great risk for volume depletion. Fluid administration is critical to optimizing oxygen delivery to organs and tissues, but giving too much fluid can induce life-threatening adverse effects. Therefore, parameters that aid clinicians in fluid management decisions may help improve patient outcomes. The most validated predictor of fluid responsiveness is pulse pressure variation (ΔPP). However, this parameter requires an invasive arterial pressure catheter, which is not appropriate for all patients, or special software, which is not available in all monitoring systems. Masimo PVI is not only noninvasive, enabling easy application on almost any patient, but is also easily obtained from existing or field upgradable Masimo Rainbow SET® pulse oximeters and sensors that are already being used to monitor SpO2 and pulse rate. In the study, Marc Feissel, MD, and colleagues at Le Centre Hospitalier Belfort-Montbeliard (CHBM) in Belfort, France, along with a team of researchers from Assistance Publique–Hôpitaux de Paris (AP-HP) in Le Kremlin-Bicetre, France, conducted a two-step analysis of 43 mechanically-ventilated patients with septic shock to: 1) identify the optimal Masimo PVI threshold for distinguishing fluid responders from non-responders; and 2) test the accuracy of PVI at the optimal threshold to predict fluid responsiveness. In the first step, researchers infused fluid (500 ml saline) in with pulse pressure variation (ΔPP) ≥ 15% and performed passive leg raising in patients with ΔPP <15% while simultaneously recording Masimo PVI and ΔPP. A >15% increase in velocity-time-integral (VTI) from echocardiography was used to determine fluid responsiveness. After comparing all data for the 25 enrolled ICU patients in the first step, researchers found that a "threshold PVI value of 20 identified patients with ΔPP >15% with a sensitivity of 84% and specificity of 90%." In the second step, researchers found that a PVI value of 20 was an effective threshold for discriminating fluid responders from non-responders among 18 additional ICU patients, with PVI >20 predicting all 8 fluid responders and PVI <20 predicting all non-responders. The researchers concluded that a PVI value of 20 "distinguished responders from non-responders with good sensitivity and specificity," and appeared to represent an "accurate index of fluid responsiveness" for critically-ill patients in the ICU. Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "We are pleased to see the value and significance of Masimo PVI in the ICU, where clinicians are often faced with difficult decisions about whether to administer fluid. While traditional invasive measurements offer limited accuracy at predicting fluid responsiveness, this study showed that a PVI threshold of 20 was able to accurately predict both fluid responders and non-responders, underscoring the strong potential for PVI to aid clinicians in optimizing fluid management and improving patient outcomes." 1 M. Feissel, R. Kalakhy, J. Badie, G. Robles, J. Faller, JL. Teboul. "Plethysmography Variability Index: A New Fluid Responsiveness Parameter." About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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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 – March 24, 2009 – 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. About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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New Clinical Study Finds Masimo Rainbow SET® Pulse CO-Oximetry™ Accurate in the Noninvasive Monitoring of Fluid Status During Surgery UCSF Researchers Presented Study Data Demonstrating the Unique Ability of Masimo PVI™ to Reflect Acute Changes in Intravascular Fluid Volume at the International Anesthesia Research Society Irvine, California – March 16, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announce that a new clinical study, independently conducted by researchers from the University of California-San Francisco (UCSF), demonstrates that Masimo PVI accurately and reliably reflects acute changes in intravascular fluid volume (preload).1 The study, presented at the International Anesthesia Research Society (IARS) 83rd Scientific Congress on March 14th in San Diego, Calif., affirms PVI as a highly predictive indicator of patient fluid status. Assessing whether a patient needs fluid to increase their cardiac index (amount of blood the heart pumps each minute) is one of the biggest challenges anesthesiologists face during surgery. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality2 and traditional invasive measurements are only 50 to 60% accurate at predicting improvement in cardiac index after volume administration.3 PVI—a new method for noninvasive and automatic assessment of fluid responsiveness—has been shown in multiple studies to predict fluid responsiveness in mechanically ventilated patients, helping clinicians to optimize fluid administration and improve patient outcomes.4-6 In the study, Errol P. Lobo, M.D., PhD, at UCSF in San Francisco, Calif., and colleagues used Masimo Radical-7 Pulse CO-Oximeters to noninvasively measure and continuously track PVI, perfusion index (PI) and pulse rate (PR) data during 16 consecutive liver transplant operations. Researchers extracted and analyzed the noninvasive data at three critical points where preload changes occur rapidly: 1) immediately before clamping, 2) during clamping, and 3) immediately after clamping of the inferior vena cava (IVC), and found that PVI changed rapidly and significantly in response to known acute changes in preload (clamping and unclamping of IVC) in 100% of the cases. The study results showed that PVI increased in response to IVC clamping (from 11.4, +/- 4.3, to 25.2, +/- 4.4; p<0.0001) and decreased after unclamping (from 25.2, +/- 4.4, to 8.9, +/- 3.8; p<0.0001) in all 16 transplant patients. Researchers concluded that this study data demonstrates that PVI may have "a role in monitoring intravascular volume in mechanically ventilated patients." PVI is available as part of Masimo Rainbow SET Pulse CO-Oximetry—a revolutionary noninvasive patient monitoring platform that measures multiple blood constituents and helps to predict fluid responsiveness in patients previously requiring invasive procedures. The first-and-only upgradable noninvasive blood constituent monitoring technology platform capable of continuously and noninvasively measuring total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and pleth variability index (PVI™), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), Masimo Rainbow SET has the potential to facilitate faster, easier and safer health decisions. Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "This UCSF study adds to the growing evidence base demonstrating PVI to be an accurate and reliable indicator of fluid status and responsiveness in mechanically-ventilated patients under general anesthesia. The ability to noninvasively and automatically assess fluid responsiveness in surgical patients has the potential to increase patient safety, improve the quality of care, and reduce the cost of care for hospitals and surgery centers." 1 E. Lobo, C. Niemann, P. Talke. Anesthesia and Perioperative Medicine, University of California-San Francisco, San Francisco, California. "Effect of Preload Changes on Pleth Variability Index During Liver Transplants." Available online at: http://www.abstractsonline.com/viewer/viewAbstractPrintFriendly.asp?CKey={FC027C9B-21B5-4032-AD74-280AEE162B5D}&SKey={1462FF08-CFFF-4A5F-95FC-D52A5461EC2C}&MKey={64BDB940-2A51-4B0D-91DB-FA4060CA2127}&AKey={733594F2-AA75-4C15-986B-948550CDD4D4} About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. Other trademarks used herein are the property of their respective owners.
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