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? Researchers in the Department of Anesthesiology at the Hamamatsu University School of Medicine in Hamamatsu-City, Japan, compared the accuracy of Masimo PVI measurements with Stroke Volume Variation (SVV) obtained via an invasive catheter (Flo Trac™) in 13 patients. After analyzing data recorded at five points—in the supine position, lateral position, start and end of one-lung ventilation, and in the supine position again—researchers found a significant correlation between PVI and SVV (r = 0.75; p = 0.02). The study concluded that "Our results suggest that an accurate prediction of fluid responsiveness can be obtained non-invasively using the PVI." 1
The Change of Upper Limbs PVI in Spinal Block (Comparison in High Spinal Block and Non-High Spinal Block) At the Tokai University School of Medicine in Tokyo, Japan, researchers examined how PVI in the upper limbs of patients undergoing caesarean procedures for hernia surgery changed in response to the level of spinal block reached. PVI was recorded in all patients before and every two minutes after spinal block was performed. In patients reaching the anesthetic level C-area—identified as the high spinal block group—PVI decreased. In patients who did not reach the C-area—identified as the non-high spinal block group—PVI of the upper limbs did not change significantly. Researchers summarized that high spinal block dilates vessels and increases blood flow in the upper limbs, which in turn, is shown by decreased PVI.2
Perfusion Index and Pleth Variability Index After Administration of General Anesthetic Agents In this study, anesthesiologists at the Teikyo University School of Medicine in Tokyo, Japan, analyzed changes in PVI and Masimo perfusion index (PI) in 21 surgical patients before and after administration of general anesthetic agents. After administration of general anesthetic agents and 10ml/kg/hr of fluid during induction, PVI significantly decreased from 22.9±8.1 to 17.1±7.2 (p<0.05) and PI significantly increased from 2.1±1.7 to 3.8±2.3 (p<0.001), leading researchers to conclude that "an increase in peripheral perfusion and improvement of fluid status and preload" occurred "after administration of general anesthetic agents and intravenous fluid administration during anesthesia induction."3
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 2 K. Takeyama, M. Yoshikawa. The change of upper limbs PVI in spinal block (The comparison in high spinal block and non-high spinal block). Eur J Anaesthesiol 2009; 26 (Suppl 45): 3AP5-1 3 J. Mizuno, Y. Morita, A. Kakinuma, S. Morita. Perfusion Index and Pleth Variability Index after administration of general anesthetic agents. Eur J Anaesthesiol 2009; 26 (Suppl 45): 4AP8-3
About Masimo 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 assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo SpHb and PVI will provide a sufficient level of sensitivity and specificity to facilitate continuous measurement capabilities and deliver clinical improvement over alternative hemoglobin and fluid assessment measurement capabilities to allow for further adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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.
According to the National Institutes of Health (NIH), more than 70 million Americans are affected by chronic sleep disorders. Sleep apnea is a very common yet serious sleep disorder where a person's breathing is uncontrollably and repeatedly interrupted during sleep, resulting in very brief or prolonged periods of oxygen deprivation. Serious problems can result from the oxygen deprivation of sleep apnea—including: heart disease, high blood pressure and learning/memory problems—and, if left untreated, sleep apnea can be life-threatening.1
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
And, based on clinician input, Rad-8 now features an intuitive user-interface and easy menu navigation to save time and enable faster, easier set-up, and operation, while one-touch quick access buttons allow clinicians to engage special features in an instant. New user-selectable alarm settings make it quick and easy for clinicians to set and save configurations for specific patient monitoring needs and unique clinical applications. In addition, 72-hour trending, configurable Sleep and Home modes, and enhanced data collection/reporting compatibility make the new Rad-8 the ideal patient monitoring solution for sleep center, home, sub-acute, and transport applications.
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 2 Robert Brouillette, MD, Jacinthe Lavergne, RRT, Andra Leimanis, BSc, Gillian Nixon, MB ChB, FRACP, Sylvia Ladan, RRT, Christine McGregor, RRT. "Differences in Pulse Oximetry Technology can Affect Detection of Sleep-Disordered Breathing in Children." Anesth Analg 2002; 94: S47-S53.
About Masimo 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 the new Rad-8 will serve to increase adoption, market share and/or revenues for the company, risks that Masimo SET sensitivity and specificity performance will be duplicated in other studies and applications, risks related to our assumption that the new Rad-8 will enable clinicians to more effectively and efficiently monitor, diagnose, and care for patients with sleep disorders, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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. 2 Surgenor SD et al, for the Northern New England Cardiovascular Disease Study Group. The Association of Perioperative Red Blood Cell Transfusions and Decreased Long-Term Survival After Cardiac Surgery. Anesthesia & Analgesia 2009; 108:1741-1746.
About Masimo 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 assumptions regarding the accuracy and repeatability of the Capgemini results; risks related to our assumption that Masimo SpHb technology and products will provide faster, easier and safer means for measuring total hemoglobin and will deliver a sufficient level of clinical improvement over alternative measurement capabilities to enable more restrictive transfusion practices, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Media Contact: Dana Banks, Masimo Corporation 949-297-7348
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.
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 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 assumption that Masimo SET and Masimo Rainbow SET will deliver a sufficient level of clinical improvement over alternative pulse oximetry and noninvasive patient monitoring solutions to allow for further adoption of the technology at other hospitals, risks related to our assumption that Duke University Hospital's system-wide conversion to Masimo technology will serve to substantially increase revenues, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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 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 assumptions regarding the repeatability of clinical results and our belief that SpCO and SpMet will improve clinical assessments and the identification of hypoxemia in patients with sickle cell disease, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Media Contact: Dana Banks, Masimo Corporation 949-297-7348
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.
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."
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 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 assumptions regarding the repeatability of clinical results, and our belief that noninvasive SpCO measurements will prove to be an effective clinical indicator of lung function and acute asthma severity in children or other patients such that SpCO measurement can effectively substitute for spirometry, as well as other factors discussed in the "Risk Factors" section of our Annual Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Media Contact: Dana Banks, Masimo Corporation 949-297-7348
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.
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 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. 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 http://www.masimo.com.
Masimo Corporation Investor Contact: Mark P. de Raad Executive Vice President and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
Masimo Reports First Quarter 2009 Financial Results
Q1 2009 Highlights:
Earnings per share increased by 47% to $0.22 per share from $0.15 in prior year
Product revenues increased approximately 25% to $74.5 million from $59.7 million in prior year
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 Masimo will hold a conference call today at 2:00 p.m. PT (5:00 p.m. ET) to discuss the results. 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. A live web cast of the conference call will be available online from the "Investor Relations" page of the Company's corporate web site at www.masimo.com. After the live web cast, the call will remain available on Masimo's website through June 5, 2009. In addition, a telephonic replay of the call will be available until 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 (NASDAQ: MASI) develops, manufactures and markets 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 clinical and laboratory 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, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO® ), methemoglobin (SpMet®) and plethysmograph variability index (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. Any information contained in, or that can be accessed through, our website is not incorporated by reference into, nor is it in any way a part of, this release.
Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about: our financial condition, results of operations, prospects and business generally; and expectations regarding our ability to design and deliver innovative new noninvasive technologies. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET and Masimo Rainbow SET products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any new products and technologies of ours; obtaining regulatory approval of our current and future products and technologies, including the recently announced total hemoglobin measurement; the risk that the implementation of our international realignment, even if timely implemented, will not produce the anticipated operational and financial benefits, including a lower effective tax rate; the loss of our customers the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the impact of the decline in the worldwide credit markets on us and our customers; the amount and type of equity awards that we may grant to employees and service providers in the future; and other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which you may obtain for free on 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Masimo Corporation Investor Contact: Mark P. de Raad Executive Vice President and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
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 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 assumption that the Rad-57 will deliver a sufficient level of sensitivity and specificity for improved CO detection over alternative methods to facilitate rapid diagnosis and treatment in the urban search and rescue environment, risks related to our belief that prior positive results and clinical outcomes achieved by the Rad-57 will be repeated in future incidents, and 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
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: The CDC case report, titled: "Carbon Monoxide Kills Three Volunteer Firefighters Inside Well in Pennsylvania," available online at: http://www.cdc.gov/niosh/face/In-house/full9030.html, illustrates the significant tragedy and inherent risks associated with rescue attempts in confined or poorly ventilated area where dangerously elevated CO levels are present.
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 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 assumptions regarding the accuracy and repeatability of the Capgemini financial model and results; risks related to our belief that the applications of Masimo Rainbow SET measurements described in the foregoing statements will deliver a sufficient level of clinical improvement over alternative measurement capabilities to create substantial financial benefits for hospitals, allow for rapid adoption of the technology, and materially increase market share and/or revenues for the company, 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 Quarterly Report on Form 10-Q 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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 (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. 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 http://www.masimo.com.
Masimo Corporation Investor Contact Mark P. de Raad Executive Vice President and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
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." Presented at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) Annual Meeting, March 25, 2009, Brussels, Belgium. http://www.intensive.org/admin/upload/abstract/1079190502/P/P205.pdf
About Masimo 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 assumptions regarding the repeatability of clinical results; risks related to our belief that PVI will prove to be an effective clinical indicator of patient hydration and the need for fluid loading, and will deliver a sufficient level of clinical improvement over alternative fluid assessment methods 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
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 83rd Scientific Congress
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} 2 Michard F, Teboul JL. "Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence." Chest. 2002 Jun;121(6):2000-8. 3 Joshi G. "Intraoperative Fluid Restriction Improves Outcome After Major Elective Gastrointestinal Surgery." Anesthesia Analgesia 2005; 101:601-5. 4 Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre." British Journal of Anaesthesia 2008; 0:aen133v1-7. 5 Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi, Aman Mahajan, M.D., Ph.D. Anestheiology, UCLA David Geffen School of Medicine, Los Angeles, California. "Ability of Pleth Variability Index to Detect Preload Changes in Orthotopic Liver Transplant Patients." 6 Olivier Desebbe, M.D., Bertrand Delannoy, R.A., Jean-Jacques Lehot, M.D., Ph.D., Olivier Bastien, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France. "Pleth Variability Index: A Noninvasive Device for Fluid Responsiveness Assessment during Anesthesia."
About Masimo 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 assumptions regarding the repeatability of clinical results; that PVI will prove to be an effective clinical indicator of patient hydration and the need for fluid loading, and will deliver a sufficient level of clinical improvement over alternative fluid assessment methods to allow for rapid adoption of the technology; and our belief that the applications of Masimo Rainbow SET measurements described in the foregoing statements will deliver a sufficient level of clinical improvement over alternative measurement capabilities to materially increase market share and/or revenues, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
Masimo Reports Fourth Quarter and Full Year 2008 Financial Results
Record results mark 22nd consecutive quarter and 14th year of consecutive product revenue growth. Company also announces international realignment to better support growing non-US business.
Q4 2008 Highlights:
Product revenues increased 29.4% to $71.4 million
Rainbow revenues increased 161% to $4.7 million
Over 31,700 Masimo SET and Masimo Rainbow SET pulse oximeter units were shipped in Q4 2008
International realignment results in a Q4 2008 tax charge of $0.25 per share and a Q4 2008 net loss of $0.01 per share; Q4 2008 earnings per share, excluding the tax charge, was $0.24 per share
Full Year 2008 Highlights:
Product revenues increased 29.7% to $258.9 million
Rainbow revenues increased 91% to $13.4 million
Over 120,000 Masimo SET and Masimo Rainbow SET pulse oximeter units were shipped in 2008
International realignment results in a Q4 2008 tax charge of $0.25 per share and full year 2008 earnings per share of $0.53; full year 2008 earnings per share, excluding the Q4 tax charge, was $0.78 per share
Irvine, California, March 3, 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 both the quarter and year ended January 3, 2009.
For the fiscal fourth quarter, Masimo reported product revenues of $71.4 million representing a 29.4% increase over $55.2 million for the fourth quarter of 2007. Including royalty revenues, Masimo reported total 2008 fourth quarter revenues of $83.1 million compared to $69.3 million for the fourth quarter of 2007. For the fourth quarter, Masimo reported a loss of $0.01 per share, resulting from a $14.9 million, or $0.25 per share, tax charge related to the implementation of its new international business organization and structure. Excluding this tax charge, fourth quarter net income would have been $14.4 million, or $0.24 per diluted share, compared to $0.20 per common share for the fourth quarter of 2007. In addition, higher research and development tax credits added $0.03 per share in the fourth quarter of 2008 and $0.02 in the fourth quarter of 2007. Masimo also reported that it shipped 31,700 Masimo SET and Masimo Rainbow SET oximetry units, excluding handheld units, during the fourth quarter of 2008, up from 29,400 in the comparable prior year period, resulting in a new estimated worldwide installed base of 567,000 Masimo SET and Masimo Rainbow SET pulse oximeters.
During the fourth quarter of 2008, Masimo implemented a new international business organization and structure designed to better serve and support Masimo's growing international business. By centralizing its international operations, including sales management, marketing, customer support, planning, logistics and administrative functions, Masimo believes it will be able to develop a more efficient and scalable international organization – capable of being even more responsive to the business needs of its international customers - all under one centralized management structure. As result of this realignment, in Q4 2008, Masimo incurred a one-time tax charge related to expenses for sharing in the costs of our ongoing research and development efforts as well as the prepayment of licensing commercial rights to utilize pre-existing intangibles. As a result of this new international business structure, Masimo believes that its future income tax rates will decline although future income tax rates will depend on various factors, including profits (losses) before taxes, changes to tax law and the geographic composition of pre-tax income.
For the fiscal year ended January 3, 2009, Masimo reported product revenues of $258.9 million, up 29.7% from $199.7 million in 2007. Including royalty revenues, Masimo's total revenues were $307.1 million for the year ended January 3, 2009, up from $256.3 million in 2007. For the year ended January 3, 2009, Masimo reported earnings of $31.9 million or $0.53 per share, including the $14.9 million tax charge related to the implementation of its new international business organization and structure. Excluding the Q4 2008 tax charge, net income would have been $46.8 million, or $0.78 per share compared to $0.60 per share in 2007. In the year ended January 3, 2009, Masimo shipped 120,100 Masimo SET and Masimo Rainbow SET pulse oximeter units, excluding handheld pulse oximeters, compared to 116,300 in 2007.
In the fourth quarter of 2008, revenues from Masimo Rainbow SET products increased to $4.7 million or 161% from $1.8 million in the same prior year quarter. For the year ended January 3, 2009, revenues from Masimo Rainbow SET products were $13.4 million, an increase of 91% compared to 2007. As a result, 2008 Masimo Rainbow SET revenues accounted for 5.2% of total product revenues up from 3.7% in 2007.
Joe E. Kiani, Chairman and Chief Executive Officer of Masimo, said, "We have been fortunate that, despite the very challenging economic environment, hospitals and physicians continue to focus on the quality and efficiency of their patients' care and, as a result, continue to migrate to Masimo's gold standard SET pulse oximetry and Rainbow SET Pulse CO-Oximetry platforms. Our on-going business model, which is based on both new product innovation and a recurring revenue stream, is continuing to show resilience in this difficult worldwide economic climate."
As of January 3, 2009, cash and cash equivalents totaled $146.9 million, up from $96.7 million at December 29, 2007, including the previously announced first quarter 2008 repayment in full of a $26.7 million debt obligation which had been established in early fiscal 2007.
Financial Guidance While providing financial guidance in this economic environment is more difficult than in prior periods, Masimo expects 2009 product revenues will be between $310 million and $315 million. Masimo also expects 2009 royalty revenues to be between $42 million to $46 million. As a result of these ranges, Masimo expects total 2009 revenues to be between $352 million and $361 million. For the full year 2009, Masimo expects its GAAP earnings per share to be between $0.83 and $0.87 per common share. Included in these 2009 earnings per share ranges are an expected reduction in year over year royalty payments, an expected increase in 2009 non-cash stock based compensation expenses of $11.9 million, up from $7.7 million in 2008 and the expected benefits from our new international business structure. The projections and guidance set forth above are estimates only and actual performance could differ.
Conference Call Masimo will hold a conference call today at 2:00 p.m. PT (5:00 p.m. ET) to discuss the results. 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 84029998. A live web cast of the conference call will be available online from the "Investor Relations" page of the Company's corporate web site at www.masimo.com. After the live web cast, the call will remain available on Masimo's website through April 3, 2009. In addition, a telephonic replay of the call will be available until March 17, 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 84029998.
Non-GAAP Measures Masimo prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. In an effort to provide investors with additional information regarding the Company's results and to provide a meaningful period-over-period comparison of the Company's financial performance, the Company uses non-GAAP financial measures as defined by the Securities and Exchange Commission. The differences between the U.S. GAAP and non-GAAP financial measures are reconciled below. In presenting comparable results, the Company discloses non-GAAP financial measures when it believes such measures will be useful to investors, analysts and other interested parties in evaluating the Company's underlying business performance on a comparable basis with past and future reported earnings per share and with the financial guidance provided in this release. Management uses the non-GAAP financial measures to evaluate the Company's financial performance against internal budgets and targets. Importantly, management believes non-GAAP financial measures should be considered in addition to, and not in lieu of, U.S. GAAP financial measures. These non-GAAP financial measures are not based on a comprehensive set of accounting rules or principles and may be different from non-GAAP financial measures used by other companies.
About Masimo Masimo (NASDAQ: MASI) develops, manufactures and markets 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 clinical and laboratory 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, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO® ), methemoglobin (SpMet®) and plethysmograph variability index (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. Any information contained in, or that can be accessed through, our website is not incorporated by reference into, nor is it in any way a part of, this release.
Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about: our financial condition, results of operations, prospects and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies; and expectations for total revenues, including royalty revenues, product revenues and Rainbow revenues, non-cash stock based compensation charges, GAAP earnings per share and non-GAAP pro forma earnings per share for the full fiscal year 2009. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET and Masimo Rainbow SET products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any new products and technologies of ours; obtaining regulatory approval of our current and future products and technologies, including the recently announced total hemoglobin measurement; the risk that the implementation of our international realignment, even if timely implemented, will not produce the anticipated operational and financial benefits, including a lower effective tax rate; the loss of our customers, the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the impact of the decline in the worldwide credit markets on us and our customers; the amount and type of equity awards that we may grant to employees and service providers in the future; and other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008 filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, which you may obtain for free on 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the risk factors contained in our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Investor Contact: Mark P. de Raad Executive Vice President, Finance and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
Three Healthcare GPOs to Offer Masimo Rainbow SET® Pulse CO-Oximetry™ to Their Members
Novation, MedAssets Supply Chain Systems, and Amerinet Also Extend Existing Multi-Year Supplier Agreements
Irvine, California – March 2, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that three of the nation's top hospital Group Purchasing Organizations (GPOs) have established a new Pulse CO-Oximetry™ category and extended multi-year supplier agreements for Masimo SET® pulse oximetry and Masimo Rainbow SET® Pulse CO-Oximetry products. Masimo licenses the technology and supplies Pulse CO-Oximetry products that noninvasively measure multiple blood constituents, which previously required invasive blood drawing procedures.
Establishing a new Pulse CO-Oximetry product category on national contract portfolios allows Novation, MedAssets Supply Chain Systems, and Amerinet to offer an innovative new selection of patient monitoring devices clinically proven to help clinicians provide earlier detection of potentially life-threatening conditions. This enables customer hospitals and healthcare facilities to purchase breakthrough noninvasive blood monitoring products that may increase patient safety, improve the quality of care, and reduce the cost of care at a great value.
Mark Miriani, President,MedAssets Supply Chain Systems, stated: "MedAssets remains focused on the important trends and issues facing the healthcare community and we recognize the importance of providing advanced technology solutions and innovative new product offerings to our customers. Pulse CO-Oximetry has the potential to improve patient safety and clinical performance, thereby delivering greater value to both hospitals and patients. We are proud to be among the first to offer Masimo Rainbow SET Pulse CO-Oximetry products on contract to our customers, creating the opportunity for measurable performance improvement as well as cost savings."
Brad Morgan, Director of Material Management, The Heart Hospital Baylor Plano, stated: "We are pleased that our GPO is making medical technologies like Masimo Rainbow SET available."
Masimo Rainbow SET Pulse CO-Oximetry is a noninvasive monitoring platform that measures multiple blood constituents and helps to predict fluid responsiveness in patients previously requiring invasive procedures. The first-and-only upgradable 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.
Martin Allard, M.B.Ch.B, FRC, Anesthesiologist, Loma Linda University Medical Center, stated: "Pulse CO-Oximetry has enormous potential. We chose the Masimo Rainbow SET Pulse CO-Oximetry platform because it provides us with the unique ability to noninvasively, continuously and immediately measure a variety of blood constituents, in addition to standard pulse oximetry measurements. Having this amount of vital physiologic data available at our fingertips has allowed us to make more rapid diagnoses, initiate intervention and treatment earlier, and make better care decisions for patients."
Rick Fishel, Masimo President of Americas and Worldwide OEM Business, stated: "Novation, MedAssets, and Amerinet are leading the way toward a new paradigm of potentially more effective and efficient patient care enabled by state-of-the-art noninvasive medical devices. These new GPO agreements reinforce the clinical and operational adoption of Masimo Rainbow SET Pulse CO-Oximetry as an emerging standard of care."
About Masimo 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 creation of a new GPO product category for Pulse CO-Oximetry will serve to broaden the use of Masimo Rainbow SET Pulse CO-Oximetry products or provide substantially increased revenues, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
United Kingdom House of Commons Safety Group Recommends Carbon Monoxide Screening by Pulse CO-Oximetry™ to Reduce Misdiagnosis and Prevent Deaths
New Evidence from London Ambulance Service Study Shows Five Masimo Rad-57 Pulse CO-Oximeters™ Detected 83 Unsuspected CO Poisonings in One Year—Over a Third of the UK Reported Annual CO Poisonings
Irvine, California – February 18, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced that in a newly published report, the UK House of Commons All Party Parliamentary Gas Safety Group (APPGSG) recommends handheld, noninvasive Pulse CO-Oximeters for Emergency Departments, primary care providers, and medical professionals who visit patients' homes as a way to improve the country's rate of detection and diagnosis of carbon monoxide (CO) poisoning.1 In addition, new evidence from a London Ambulance Service pre-hospital CO screening study shows that using the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter significantly improved detection of CO poisoning at an earlier stage, while reducing unnecessary hospital transports and patients entering the Accidents & Emergency system.2
The UK House of Commons APPGSG report, 'Raising Medical Professionals' Awareness of Carbon Monoxide Poisoning,' cites "increasing concern that little is being done to ensure that medical professionals are able to correctly diagnose the symptoms of carbon monoxide and treat victims effectively," as the catalyst that ultimately resulted in the group's January 2009 report and recommendations for action. The UK National Health Service (NHS) reports that hundreds of people are seriously injured or killed by CO poisoning in the UK each year.3 However, the APPGSG suggests that because of the lack of adequate testing, the actual number may be much higher. In addition, because the vast majority of cases simply go to their GP complaining of symptoms similar to the flu, the incidents of misdiagnosis by medical professionals are grossly under-reported.
"From the collated data, information gained during and prior to the feasibility study and correspondence with other interested agencies it is clear that there are gaping holes in the way that CO poisoning is recognised, monitored, treated, recorded and publicised in the United Kingdom," stated Andrew Humber, Team Leader, London Ambulance Service.
While authors of the APPGSG report advise that "targeting improved diagnosis of CO poisoning is doubly important not just in containing the immediate effects of the illness, but also in reducing the need to direct resources toward tackling subsequent chronic or acute medical problems," a year-long feasibility study also released in January 2009 by the London Ambulance Service demonstrates Masimo Rad-57's ability to deliver these benefits.
In their report, 'A Feasibility Study into Pre-Hospital Carbon Monoxide Monitoring of Patients,' the London Ambulance Service equipped three First Response Units (FRU) and two Hazardous Area Response Team (HART) vehicles with Rad-57s to determine the benefits of pre-hospital CO monitoring and found that the ability to noninvasively screen patients on the scene made an important difference in six key ways:
Earlier detection & treatment of CO poisoning
Prevention of further harm, possible higher level intoxications & long-term effects of untreated exposure
Reduced clinical risk to the ambulance service & increased safety for the attending crew
Improved on-scene triage ensures the fastest & most appropriate care (A&E or Hyperbaric)
Reduction in unnecessary hospital transports & patients entering the A&E system
Increased efficiency gains as ambulances/crews returned to core duties earlier
Prior to this study, London Ambulance crews had no way to accurately diagnose CO poisoned patients. With just five Rad-57s, the London Ambulance Service was able to diagnose and treat 83 patients with unsuspected CO poisoning in a year, which is over a third of the reported annual number of CO poisonings in the UK. "On site monitoring of carbon monoxide blood levels mean that the paramedics are now able to triage patients at scene and receive expert advice at the scene, so that they take patients to the most appropriate A&E department and those with severe CO poisoning can now be referred directly to appropriate hyperbaric units," stated Andrew Humber. "It is due to this that there has been a marked improvement in the time to treatment."
Masimo Founder and CEO, Joe E. Kiani, stated: "The UK recommendations and London Ambulance Service study are a call to action for all medical and emergency professionals who see patients with potential carbon monoxide poisoning. We are proud that the technology we have invented and produced is helping these professionals improve and save lives."
About Masimo 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 positive results and clinical outcomes achieved in the London Ambulance Service study will be repeated in other studies, and risks related to our assumption that the Masimo Rad-57 will deliver a sufficient level of sensitivity and specificity for improved carbon monoxide detection over alternative methods to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
Masimo to Present at the Roth Capital Partners 21st Annual OC Growth Stock Conference
Irvine, California – February 6, 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 Roth Capital Partners 21st Annual OC Growth Stock Conference at The Ritz-Carlton, Laguna Niguel in Dana Point, California, on Wednesday, February 18, 2009, at 11:00 a.m. PT. 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 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.
Masimo Corporation Investor Contact: Mark P. de Raad Executive Vice President and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
New Clinical Study Presented at the Society for Critical Care Medicine Shows Value of Pulse CO-Oximetry™ to Identify Acquired Methemoglobinemia
1 out of 7 HIV+ Patients Receiving Dapsone Therapy at Significant Health Risk Due to Dangerously High Levels of Methemoglobin
Irvine, California – February 6, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced that a new study presented at the Society for Critical Care Medicine 38th Critical Care Congress suggests providers should consider routine screening with Masimo Rainbow SET Pulse CO-Oximetry for the immediate and noninvasive detection of potentially life-threatening acquired methemoglobinemia in patients receiving Dapsone therapy. Results showed that "Dapsone therapy is associated with a clinically significant elevation of methemoglobin levels" in 1 out of 7 HIV+ patients.
In the study, Hollis R. O'Neal, M.D., and colleagues at the Vanderbilt University School of Medicine in Nashville, TN, found that 32% of HIV positive patients receiving chronic Dapsone therapy, a commonly used antimicrobial agent for the treatment of prophylaxis of pneumocystis jirovecii pneumonia (PCP), had elevated methemoglobin blood levels (>2%) and 15% had dangerously high methemoglobin blood levels (>3%) when compared to a control group of HIV positive patients not receiving Dapsone.1 Dapsone has been shown to cause potentially deadly levels of methemoglobin—a damaged form of hemoglobin that cannot bind to oxygen—to accumulate in the blood. Elevated methemoglobin concentration reduces oxygen delivery to vital organs and tissues, which can lead to brain and organ damage, or even death.2 The researchers concluded: "As noninvasive Pulse CO-Oximetry is now available, providers should consider the routine screening of persons receiving Dapsone for methemoglobinemia."
Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly, stated: "Previous studies have shown that methemoglobinemia can occur in any patient type in any care area of the hospital. This study reinforces the need for clinicians to quickly, easily and conveniently screen all patients receiving Dapsone therapy using Masimo Rainbow SET Pulse CO-Oximetry as the first line of defense and prevention against acquired methemoglobinemia."
1 Hollis R. O'Neal, John H. Newman, Catherine McGowan, Stephen P. Raffanti, Timothy Sterling, Vanderbilt University School of Medicine, Nashville, TN. "The Prevalence of Methemoglobinemia in HIV-Infected Patients on Chronic Dapsone Therapy for Prophylaxis of Pneumocystis Jirovecci Infection." Society of Critical Care Medicine, February 2, 2009. 2 Ash-Bernal, R., Wise, R., Wright, SM. "The Johns Hopkins Study: Acquired Methemoglobinemia." Medicine (Baltimore). 2004 Sep;83(5):265-73.
About Masimo 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 positive results and clinical outcomes achieved in this study will be repeated in other studies, and risks related to our assumption that Masimo Rainbow SET Pulse CO-Oximetry technology and devices will deliver a sufficient level of sensitivity for improved methemoglobinemia detection over alternative methods to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
Masimo to Report Fourth Quarter and Fiscal Year 2008 Financial Results on March 3, 2009
Conference call and webcast to begin after markets close at 2:00 p.m. PT (5:00 p.m. ET)
Irvine, California – February 5, 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 fourth quarter and fiscal year 2008 financial results for the period ended January 3, 2009 after the market closes on Tuesday, March 3, 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 84029998. After the live webcast, the call will remain available on Masimo's website through April 3, 2009. In addition, a telephonic replay of the call will be available through March 17, 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 84029998.
About Masimo 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. 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 http://www.masimo.com.
Investor Contact: Mark P. de Raad Executive Vice President and Chief Financial Officer Masimo Corporation (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks Manager, Public Relations Masimo Corporation (949) 297-7348 dbanks@masimo.com
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.
Masimo Files Patent Infringement Suit Against Philips
Irvine, California – February 3, 2009 –Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced that it has filed a patent infringement suit against Philips Electronics North America Corporation and Philips Medizin Systeme Böblingen Gmbh related to Philips FAST pulse oximetry technology and certain Philips patient monitors. The suit was brought in the United States District Court for the District of Delaware. Two patents at issue in this suit, related to Masimo's measure-through-motion technology, were successfully enforced in a previous suit by Masimo against Nellcor.
Masimo Founder and CEO, Joe E. Kiani, stated: "Given that Philips and Masimo have a long-term business relationship, we have patiently tried to resolve our differences regarding Philips' infringement of Masimo's patents without seeking the courts' intervention. Unfortunately, since our best efforts have not been successful, we believe we have no choice but to rely on the courts to resolve this dispute."
Masimo and Philips continue to be engaged in a long-term OEM agreement. Masimo intends to comply with the terms of the agreement, continuing to provide Philips with Masimo SET® technology for integration into Philips monitoring products, to the benefit of both companies' mutual customers.
About Masimo 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. Important factors that may cause such a difference for Masimo in connection with our litigation with Philips include, but are not limited to: our ability to prevail in the lawsuit against Philips, including any appeals; the ability of our patents to protect our intellectual property and products; our ability to enforce our intellectual property rights; and the risks associated with litigation in general, including the costs and time that must be devoted to litigation, the potential diversion of the attention of management and key employees that may result from being engaged in litigation, and the possibility of adverse results. Additional factors that may cause Masimo's actual results to differ materially from those expressed in forward-looking statements include, but are not limited to: those factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Steve Moran, Executive Vice President, General Counsel & Secretary Masimo Corporation 949-297-7015
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.
New Multi-Center Study Finds Masimo SET Pulse Oximetry Screening Significantly Improves Detection of Congenital Heart Disease in Newborns
Study Published in British Medical Journal Indicates Masimo SET May Also Reduce the Need for Pre-Operative Neonatal Intensive Care and Prevent Long-term Neurological Morbidity
Irvine, California – January 30, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced that a new multi-center study of 39,821 newborns was published in the January 2009 issue of the British Medical Journal (BMJ). When compared to a cohort group of 108,604 newborns in whom no pulse oximetry screening was used, the study found that the addition of Masimo SET pulse oximetry screening before discharge increased detection of Congenital Heart Disease (CHD) by 28% (from 72% to 92%). In addition, researchers noted that "no baby died from undiagnosed duct dependent circulation" in the Masimo SET group, while five babies from the cohort group died during the same period.1
In the study, Anne de-Wahl Granelli, M.D., of the Queen Silvia Children's Hospital in Goteborg, Sweden, and colleagues screened babies born between 2004 and 2007 at five well baby nurseries using Masimo SET pulse oximetry. A positive pulse oximetry result was defined as an oxygen saturation of <95% measured both preductally (right hand) and postductally (either foot), or a measurement difference >3% between the two measurements. The study found that the positive predictive value of pulse oximetry screening was at least seven times higher than the best-case scenario for standard neonatal physical examination alone (20.7% vs. 3.1%).
Undiagnosed CHD presents devastating long-term morbidity and mortality risks, with 10-30 percent of the babies who die from CHD remaining undiagnosed until autopsy.2 Additionally, study authors noted that the rise in the proportion of babies who leave the hospital with undiagnosed critical CHD had multiple contributing factors, such as earlier discharge from maternity wards, the growing prevalence of babies rooming with their mothers instead of observational nurseries and reductions in pre-discharge neonatal clinical exams.
The researchers concluded that Masimo pulse oximetry screening of "all well babies in maternity units is practically feasible with a minimum use of nursing time" and that it "significantly improves" detection of duct dependent CHD. Researchers also commented that "the low false positive rate, the fact that other important pathology is unearthed by the screening and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective."
The current study adds to previous research conducted by Dr. Granelli, which demonstrated that when compared to conventional pulse oximetry, only Masimo SET pulse oximetry is accurate and reliable for improving the detection of critical CHD.3
Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "Undiagnosed CHD frequently places the lives of newborns in grave danger. To ensure that these newborns are given the absolute best chance at survival, pre-discharge CHD detection and diagnosis is critical. The comprehensive population and protocol data gathered by these researchers demonstrate that the superior sensitivity and specificity of Masimo SET pulse oximetry technology is key to substantially increasing the ability to accurately diagnose CHD before newborns are discharged from the hospital."
1 Anne de-Wahl Granelli, et al., "Impact of Pulse Oximetry Screening on the Detection of Duct Dependent Congenital Heart Disease: a Swedish Prospective Screening Study in 39,821 newborns." BMJ. 2009; 338;a3037. Available online at: http://www.bmj.com/cgi/content/full/338/jan08_2/a3037 2 Bonnet D, Coltri A, Butera G, Fermont L, Le Bidois J, Kachaner J, et al., "Detection of transposition of the great arteries in fetuses reduces neonatal morbidity and mortality." Circulation 1999;99:916-8. 3 Anne de-Wahl Granelli, et al., "Screening for Duct-dependent Congenital Heart Disease with Pulse Oximetry: A Critical Evaluation of Strategies to Maximize Sensitivity.." Acta Paediatrica. 2005; 94:1590-1596.
About Masimo 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 positive results and clinical outcomes achieved in this study will be repeated in other studies, and risks related to our assumption that Masimo pulse oximetry technologies and devices will deliver a sufficient level of sensitivity for improved CHD detection over alternative methods of newborn screening to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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.
MedAlliance signs agreement with Masimo to provide an innovative offering of Masimo SET® pulse oximetry and Masimo Rainbow SET® Pulse CO-Oximetry™ products
(LONDON, ON): MedAlliance, Canada's newest and most flexible healthcare Group Purchasing Organization, is pleased to announce the signing of an agreement with Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, that provides Members across Canada with tremendous value on a comprehensive and innovative offering of pulse oximetry and Pulse CO-Oximetry products.
The agreement gives MedAlliance Members immediate and direct access to Masimo's entire product offering, featuring industry-leading patient monitoring technologies that may enable clinicians to provide earlier detection and treatment of potentially life-threatening conditions to help increase patient safety, improve the quality of care, and reduce the cost of care. This includes Masimo SET® pulse oximeters, Masimo Rainbow SET® Pulse CO-Oximeters, as well as Masimo's full array of noninvasive sensors and advanced patient monitoring solutions.
"We are very pleased to partner with Masimo to provide savings to our membership," notes Leslie McGill, President of MedAlliance. "The purchase of capital equipment represents a critical, but significant expenditure for hospitals. The purpose of MedAlliance is to provide more choice and flexibility in purchasing, while also helping Canadian healthcare organizations achieve lower supply costs. This pulse oximetry agreement with Masimo will help us achieve our goal."
This new agreement marks the very first MedAlliance contract in the pulse oximetry category and joins a growing roster of multi-source, choice-based contracts, which will give healthcare providers savings in a wide range of contract areas including capital equipment, specialty medical/surgical products, medical implants and devices, maintenance, operations and repair supplies, and laboratory supplies.
The MedAlliance pulse oximetry contract with Masimo is now in place for Q4 purchases.
"We are proud to partner with MedAlliance in establishing a 'gold standard' pulse oximetry supply chain agreement built on the Masimo SET and Masimo Rainbow SET foundation of clinical, operational and patient safety excellence," says Masimo Founder and CEO, Joe E. Kiani. "This agreement allows MedAlliance member hospitals, health authorities and non-profit healthcare organizations throughout Canada to access advanced Masimo pulse oximetry technology and emerging Pulse CO-Oximetry standards of care at a great value."
About Masimo's Pulse Oximetry Offering Masimo offers an extensive selection of pulse oximetry and Pulse CO-Oximetry solutions, including handheld and bedside devices; reusable and single patient use sensor options; remote monitoring and clinician notification systems; as well as its proprietary SatShare interface, which allows for a simple upgrade of an existing multi-parameter monitor to Masimo SET performance. And, since Masimo SET is the leading Measure-Through Motion and Low Perfusion SpO2 solution in more than 100 multi-parameter monitors and 50 monitoring brands worldwide, hospitals can easily integrate Masimo technology into any clinical setting.
Masimo Rainbow SET Pulse CO-Oximetry is a breakthrough noninvasive monitoring platform that measures multiple blood constituents and helps to predict fluid responsiveness in patients previously requiring invasive procedures. The first-and-only upgradable 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's newest noninvasive innovation, SpHb, allows healthcare professionals to instantaneously and continuously measure a patient's hemoglobin level in real-time to potentially detect chronic or acute anemia faster, identify occult bleeding earlier, and more effectively manage blood transfusions. With Masimo SpCO and SpMet, clinicians can quickly and accurately determine a patient's blood level of carboxyhemoglobin and methemoglobin—two critical dyshemoglobins proven to increase morbidity and mortality in a broad range of clinical settings.1-2 And, Masimo PVI is a new method for the noninvasive, automatic quantified measurement of dynamic changes that may help clinicians assess fluid responsiveness in patients.
For more information on the product offering and how to participate in this contract opportunity, please contact info@medalliancecanada.ca.
1 Kao, et al., "Carbon Monoxide Poisoning. " Emergency medicine Clinics of North America. 22 (2004), pp. 985-1018 2 Ash-Bernal R, et al. "Acquired Methemoglobinemia A Retrospective Series of 138 Cases at 2 Teaching Hospitals." Medicine Sept 2004;83(5):265-273.
About the Partners
MedAlliance Supply Chain Services Corporation is Canada's newest and most flexible healthcare Group Purchasing Organization. A wholly owned subsidiary of Medbuy Corporation, MedAlliance is designed to assist Canadian hospitals in managing their supply chain cost through a wide variety of choice-based contracting services that maximize savings in the categories of capital equipment; specialty medical/surgical products; medical devices and implants; maintenance, operations and repair supplies; and laboratory supplies. Together with our partners, MedAlliance is changing the face of healthcare procurement in Canada. For more information, visit www.medalliancecanada.ca.
Medbuy Corporation is Canada's leading healthcare Group Purchasing Organization. We deliver the best net price, at the lowest cost, of any Canadian healthcare GPO while securing value-added benefits that grow our Members' knowledge base. Medbuy is guided by the principles of contract commitment and compliance, while offering a comprehensive offering of national single-source contracts for healthcare supplies, pharmaceuticals and services. Maximizing supply chain savings means Medbuy Member hospitals can redeploy critical dollars where it counts – to patient care. For more information, visit www.medbuy.ca.
About Masimo 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 assumption that entering into a multi-year agreement with MedAlliance will serve to broaden the use of Masimo SET pulse oximetry and Masimo Rainbow SET Pulse CO-Oximetry technologies or will serve to provide substantially increased revenues for the company, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
For further information, please contact: Leslie McGill President MedAlliance Supply Chain Services Corporation 519-652-1688 lmcgill@medalliancecanada.ca
Dana Banks Masimo Corporation 949-297-7348
Medbuy is a registered trademark of Medbuy Corporation. MedAlliance is a trademark of MedAlliance Supply Chain Services Corporation.
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. CPT is a registered trademark of the American Medical Association.
Clinicians at Dartmouth-Hitchcock Medical Center Present New Data Showing Masimo Rainbow SET® Oximetry and Patient SafetyNet™ Improves Patient Outcomes and Reduces the Cost of Care
Presentation at the Society for Technology in Anesthesia Annual Meeting Quantifies Decreases in Rescue Calls and ICU Transfers with Improved ICU Utilization
Irvine, California – January 20, 2009 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced that a team of clinicians at Dartmouth-Hitchcock Medical Center (DHMC) presented new outcome data from their year-long implementation study showing Masimo Rainbow SET Pulse CO-Oximetry and Patient SafetyNet remote monitoring and clinician notification system helps improve patient outcomes and reduce the cost of care by decreasing rescue calls and ICU transfers, resulting in improved ICU utilization. Study findings were presented at the Society for Technology in Anesthesia (STA) Annual Meeting in San Antonio, Texas on January 15, 2009.
Clinical data tracked by Dr. George T. Blike, Medical Director of Patient Safety, and his team at DHMC during the 12-month study period showed that, after the implementation of Masimo Rainbow SET and Patient SafetyNet, there was a 70% reduction in rescue calls and a 48% reduction in ICU transfers. In addition, the team found that the reduction in ICU transfers helped to free up an estimated 163 ICU-days annually for its 36-bed post-surgical unit, thereby increasing ICU access for more critically ill patients. The findings and data also indicate that there is a measurable cost advantage associated with Masimo Patient SafetyNet's ability to assist clinicians in the identification of the onset of patient distress earlier—preventing codes, rescues, and ICU transfers—contributing to significant decreases in patient care costs on the general care floor.
Financial data presented by the team showed that the cost of care for patients undergoing bilateral or multiple major joint prosthesis operations of the lower extremity who did not deteriorate to the point of rescue was 60% less ($19,987) than the cost of care for patients who did ($49,602). Additionally, the length of stay for non-rescued patients was 68% shorter than that of rescued patients (3.9 days versus 12.3 days). For major joint replacement operations of the lower extremity, the length of stay for patients who did not require a rescue call was 38% shorter (3.6 days versus 5.8 days), which resulted in a 31% decrease in their cost of care ($13,648 versus $19,765).
George T. Blike, M.D., Medical Director of Patient Safety at DHMC, stated; "The data tracked in this 12-month study demonstrates that routine patient monitoring on the general care floor using Masimo Rainbow SET and the Patient SafetyNet system, with its ability to measure oxygen saturation continuously and directly page a nurse when problems are identified, was associated with statistically significant reductions in the need for urgent and emergent interventions. Initial analysis shows we reduced the need for ICU transfers and, we believe, the cost of care through early detection and intervention of physiologic abnormalities. These results are such that we have expanded implementation of the system to two additional post-surgical units."
The Masimo Patient SafetyNet system combines the "gold standard" Measure-Through Motion and Low Perfusion performance of Masimo Rainbow SET Pulse CO-Oximetry technology with wireless clinician alerts via pager to help provide a new level of safety to patients on general care floors, where nurse-to-patient ratios preclude the level of direct surveillance required and recommended to preempt adverse events. When physiologic parameters deteriorate, Masimo Patient SafetyNet system provides accurate, actionable alarm notification directly to a qualified clinician—enabling immediate and early intervention.
The growing frequency of unrecognized adverse incidents and avoidable patient safety issues resulting in death or serious physical injury is a preventable and costly human tragedy that the Journal of the American Medical Association has reported may account for 2.4 million extra hospital days, over 32,500 deaths, and $9.3 billion in excess charges in the United States annually.1 These startling statistics have prompted the convergence of leading healthcare accreditation and industry groups toward a common patient safety standard of continuous, noninvasive physiologic monitoring linked to an appropriate clinician alert and notification system for perioperative patients.
The Joint Commission's National Patient Safety Goals call for the "improved recognition and response to changes in a patient's condition" and recommend "a suitable method that enables health care staff members to directly request additional assistance from a specially trained individual(s) when the patient's condition appears to be worsening."2 The Anesthesia Patient Safety Foundation (APSF) recommendations advise healthcare professionals to "give consideration to the potential safety value of continuous postoperative monitoring of oxygenation and ventilation in at-risk patients without delay," urging that "it is critical that any monitoring system be linked to a reliable process to summon a competent healthcare professional to the patient's bedside in a timely manner."3 The American Society of Anesthesiologists (ASA) Clinical Practice Guidelines have established that "continuous pulse oximetry monitoring in a step-down unit reduces the likelihood of perioperative complications among patients who are believed to be at increased perioperative risk from OSA."4
Masimo Founder and CEO, Joe E. Kiani, stated; "By revolutionizing pulse oximetry with the invention of Signal Extraction Technology (SET), we created a new era where pulse oximeters could measure through motion and low perfusion, resulting in the virtual elimination of false alarms with an increased ability to detect true events. The clinical community and Masimo collectively hoped that our technology could help caring clinicians improve the quality of care for their patients. In the last ten years, we have witnessed our technology being used to help save the eyesight of neonates, detect congenital heart defects in newborns and save countless lives. The evidence gathered by Dr. Blike and his team at Dartmouth-Hitchcock Medical Center continues to illustrate the substantial impact of Masimo technology on patient safety benchmarks. These caring clinical professionals have done their hospital and the medical community a great service by implementing a solid protocol with Masimo Rainbow SET and Patient SafetyNet to more effectively and efficiently care for their patients after surgery on the general care floor. Their results provide a compelling case and opportunity for hospitals to improve healthcare outcomes while decreasing costs."
A study published in the Journal of Critical Care Medicine estimates that there are approximately 820,000 unmonitored beds in non-critical care settings in the U.S.
1 The Journal of the American Medical Association (JAMA). Excess Length of Stay, Charges, Mortality Attributable to Medical Injuries During Hospitalization, 2003. 2 The Joint Commission: "Facts about the 2008 National Patient Safety Goals"; June 1, 2007. http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_npsgs.htm 3 Anesthesia Patient Safety Foundation (ASPF) Initiatives: "Safety During Patient-Controlled Analgesia"; October 13, 2006. www.apsf.org/initiatives/pca.mspx 4 American Society of Anesthesiologists (ASA): "Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea"; Anesthesiology 2006;104:1081-93.
About Masimo 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 assumption that the positive results and clinical outcomes presented by Dartmouth-Hitchcock Medical Center will be repeated at other hospitals, risks related to our assumption that Masimo Patient SafetyNet will deliver a sufficient level of clinical improvement over alternative remote monitoring systems to allow for rapid adoption of the technology on general care floors, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission ("SEC") on October 29, 2008, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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. CPT is a registered trademark of the American Medical Association.
