First Nursing Facility Installation of Masimo Patient SafetyNet™ Goes Live with "Remarkable" Results
State-of-the-art, remote monitoring and clinician notification system helps keep nursing facility patients safe and clinicians happy
Irvine, California – June 26, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, today announced the first installation of the Masimo Patient SafetyNet remote monitoring and clinician notification system outside of a hospital setting. The East Tennessee Respiratory Center at Hillcrest North, a skilled nursing facility in Knoxville, TN, installed the Patient SafetyNet system after Respiratory Support Services (RSS)—the center's respiratory care providers—outlined the significant clinical benefits that were possible with the system.
"Masimo Patient SafetyNet has made a remarkable difference in almost every aspect of respiratory care at the Hillcrest North facility," stated Gene Gantt, Chief Executive Officer of RSS. "Evidence of Masimo Patient SafetyNet's effect on patient safety is undeniable. After installation, we immediately noticed a reduction in false alarms by more than 60 percent and a marked reduction in hospital readmissions and acute care transfers, while the effectiveness of our ventilator weaning program and our clinical efficiency has improved."
Skilled nursing facilities are private institutions that present a unique challenge to patient monitoring. There are no glass windows to make observation of a patient in the privacy of their own room easy. Without an appropriate remote monitoring and clinician notification system, physiological early warning indicators—such as decreases in oxygen saturation and pulse rate, which often precede respiratory distress or cardiac arrest—may go unobserved.
"In this setting, it is difficult to adequately monitor patients without compromising their privacy or comfort," said Scott Gantt, Chief Operating Officer of RSS. "Masimo Patient SafetyNet allows us to monitor patients remotely and provides early warning alarms that tell us when the physiological parameters we have set for the patient are violated. This enables clinicians to immediately respond to the patient's bedside and initiate care before a potentially more severe event occurs."
Combining the "gold standard" Measure-Through-Motion-and-Low-Perfusion performance of Masimo Rainbow SET Pulse CO-Oximetry technology with wireless clinician alerts via pager, Patient SafetyNet provides a new level of safety to patients in settings that preclude the level of direct surveillance required and recommended to preempt adverse events. Masimo Rainbow SET Pulse CO-Oximetry is the first-and-only technology platform capable of continuously and noninvasively measuring many blood constituents that previously required invasive procedures, including total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO™), methemoglobin (SpMet™), pleth variability index (PVI), oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate. At the heart of the system is Masimo SET pulse oximetry, clinically proven to have the highest sensitivity (98 percent) and specificity (97 percent) through conditions of motion and low perfusion.1
"We are very excited about the Masimo Patient SafetyNet system and the improvements in care that we have already realized since implementing the system at Hillcrest North," stated Carolyn Pointer, BSN, MPH, NHA, President and CEO of Hillcrest HealthCare Communities. "In fact, we look forward to expanding the benefits of Patient SafetyNet to other facilities within our network and continuing to lead the long-term care arena in advancements in technology, monitoring and patient care improvements."
Rick Fishel, President of Masimo Americas, stated "Patient safety and quality of care are critical success factors in any inpatient setting. This installation illustrates the impact and value of Masimo Patient SafetyNet beyond the hospital setting. Respiratory Support Services and Hillcrest North are pioneering the use of this advanced patient monitoring technology in long-term care facilities with results that not only show improvements in patient safety, but also in patient outcomes. We applaud them for their vision, leadership and commitment to making a difference in the care of patients."
1 Shah N, Estanol L. " Impact of Motion and Low Perfusion on SpO2 & Pulse Rate in Three New Generation POs in Volunteers." Anesthesiology 2006; 105: A1433.
About Respiratory Support Services (RSS) RSS is a full service post-acute care network providing respiratory therapy (RT) personnel, equipment and supplies, as well as consultancy and management services, to facilities like Hillcrest North in five southern states. In addition, RSS has successfully lead efforts to add continuous pulse oximetry monitoring to the Tennessee Standards for Ventilator Care in Rehabilitation Facilities and the American Association for Respiratory Care (AARC) Quality Respiratory Care Recognition Program.
About Hillcrest HealthCare Hillcrest HealthCare offers services in four locations throughout Knox County, Tennessee. Hillcrest North, the largest campus with two buildings and 271 licensed beds, provides both skilled and long-term care. Hillcrest West and Hillcrest South are long-term care facilities with 194-beds and 95-beds, respectively, and LakeBrook Place is a 28-bed assisted-living facility.
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, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that the positive results and clinical outcomes represented by Respiratory Support Services at the Hillcrest North Skilled Nursing Facility will be repeated at other hospitals, 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 quarter ended March 29, 2008, filed with the Securities and Exchange Commission on May 1, 2008. 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. 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 quarter ended March 29, 2008, whether as a result of new information, future events or otherwise, except as may be required under the federal 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.
Dartmouth-Hitchcock Medical Center Evaluation Findings Demonstrate Masimo Patient SafetyNet™ Delivers Improvements in Clinical Outcomes and Patient Safety on General Care Floors
Early results show positive impacts on safety, quality of care, clinician efficiency and nursing satisfaction
Irvine, California – May 28, 2008 – Dartmouth-Hitchcock Medical Center and Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, today announced that initial results of an ongoing clinical evaluation show Masimo Patient SafetyNet with Masimo Rainbow SET Pulse CO-Oximetry provides early warning detection of impending patient deterioration on the general care floor, which helped keep patients safer. Early findings showed a reduction in distress codes, rescue activations, and ICU transfers. Dartmouth-Hitchcock Medical Center (DHMC), the first hospital to deploy the Masimo Patient SafetyNet system, presented its evaluation data and findings to more than 1,500 clinicians at the 4th International Conference on Rapid Response Systems on May 8, 2008 in Toronto, Canada, and the National Patient Safety Foundation (NPSF) Annual Congress on May 15, 2008 in Nashville, TN.
George T. Blike, M.D., Medical Director, Patient Safety, DHMC, stated "The data that we have gathered by continuously monitoring all patients on a post-surgical general care floor since beginning this evaluation in late 2007 confirms what we anticipated—an improvement in prevention and intervention. The Masimo Patient SafetyNet system makes it possible for our clinicians to identify patient distress earlier—preventing codes and rescues—and initiate appropriate intervention more rapidly to improve patient outcomes, recoveries and clinician efficiencies. All of this contributes to a safer general care floor for our patients."
Findings presented by DHMC showed an 80 percent decrease in distress codes and rescue activations and a 50 percent decrease in ICU transfers for Masimo Patient SafetyNet system-monitored patients in a 36-bed post-surgical unit. In addition, data gathered during the three-month evaluation, covering 2,587 total patient days, showed that the Masimo Patient SafetyNet system supported the early identification of patients with sedation or analgesia-induced respiratory depression, cardiac anomalies identified by high and low pulse rate, poor heart rate control, acute bradycardia needing atropine, new onset A-fib, unrecognized obstructive patterns of respiration like sleep apnea, and pulmonary complications such as fat emboli syndrome, pulmonary embolus and edema.
"The bottom line is that the earlier patient distress is discovered and intervention is initiated, the better the recovery will be—enabling patients to get better faster and go home quicker," said Dr. Blike. "The decreases in codes, rescue activations and ICU transfers are crucial indicators that we are catching deteriorations much earlier and that patients are safer because of it. We expect that our continued evaluation efforts will yield more financial and statistical data concerning Patient SafetyNet's impact on length of stays, patient throughput and new diagnosis identifications."
An influx of more acute patients, the growth and use of patient-controlled analgesia, an increasing number of patients with obstructive sleep apnea, and the ongoing clinician shortage are the realities of today's general care floors. As a result, patients on general care floors are at increased risk of un-witnessed adverse physiological events, like respiratory distress or cardiac arrest. If the patient is not monitored reliably using pulse oximetry technology with high specificity and sensitivity, adverse events on the general care floors may result in long-term health complications or death. Only Masimo Rainbow SET Pulse CO-Oximetry technology provides the greatest sensitivity, at 98 percent, and the greatest specificity, at 97 percent, based on independent and objective references that have examined oximeter performance in real clinical environments.
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 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 physiological parameters are violated, such as arterial blood oxygen saturation or pulse rate, Masimo Patient SafetyNet provides accurate, actionable alarm notification directly to a qualified clinician—enabling immediate notification and early intervention.
While previous attempts at monitoring patients on the general care floors have failed because of excessive false alarms, the advanced technology of Masimo SET pulse oximetry has virtually eliminated false alarms while delivering the most accurate and reliable arterial blood oxygen saturation and pulse rate measurements. Clinically-proven in more than 100 independent and objective studies to have the highest sensitivity and specificity through conditions of motion and low perfusion—the most common source of false alarms with other pulse oximetry technologies—Masimo SET provides the foundational technology for Masimo Rainbow SET Pulse CO-Oximetry.
"Our data shows overall alarm rates of 4.1 per patient per day on our post-surgical general care floor," said Jean Avery, MBA,RN, Clinical Improvement, DHMC. "On an unmonitored patient, many of these alarm conditions would have gone unnoticed."
"One major East Coast hospital that tried to monitor patients continuously on the general care floor before the advent of Masimo SET pulse oximetry experienced about 36,000 alarms per month for 12 beds, which translated to about 96 alarms per patient day," said Jim Welch, Vice President of Patient Safety Initiatives at Masimo. "The high rate of false alarms due to conventional pulse oximetry's limitations made monitoring on the general floor impractical, if not impossible. With just 4 alarms per patient per day at DHMC, Masimo's revolutionary Measure-Through-Motion pulse oximetry finally enables accurate and reliable monitoring on general care floors."
Also, as part of the evaluation, DHMC surveyed nursing staff in the unit equipped with Masimo Patient SafetyNet and found that they were overwhelmingly satisfied with the system. When asked to assess their feelings toward the new surveillance system, the unit's nursing staff "strongly agreed" that the ability to provide surveillance has added benefit in providing safe care to patients. In addition, the nursing staff indicated that they would "definitely" want a friend or relative needing inpatient care to come to the unit equipped with a surveillance monitoring system..
"Our nurses are discovering patients in need of attention, much sooner than before," stated Nancy Karon, BSN, RN, Clinical Coordinator, DHMC. "Patient SafetyNet has improved patient care with high levels of nurse satisfaction because they know they are able to deliver the best possible quality of care to their general care floor patients."
Joe E. Kiani, Chairman and CEO of Masimo, stated "Quite simply, we developed Masimo Patient SafetyNet to help clinicians save lives and improve patient outcomes. The empirical and statistical data being gathered through Dartmouth-Hitchcock Medical Center's evaluations are providing the necessary details that demonstrate how Masimo's Measure-Through-Motion pulse oximetry technology along with the Patient SafetyNet system are impacting critical patient safety benchmarks, such as the number of sentinel events, codes, rapid response team activations and ICU transfers. Ranked as one of the top academic medical centers in the U.S. and named as one of the nation's most wired medical centers by Hospitals and Health Networks magazine, DHMC was the ideal pilot installation for Masimo Patient SafetyNet. These findings support the necessity and value of Masimo Patient SafetyNet on general care floors."
A study published in the Journal of Critical Care Medicine suggests that there are approximately 820,000 unmonitored beds in non-critical care settings in the U.S.
About Dartmouth-Hitchcock Medical Center Nationally-ranked as one of the top academic medical centers, Dartmouth-Hitchcock Medical Center provides comprehensive inpatient and outpatient services to patients from throughout New England. With more than 21,500 inpatient admissions, 28,700 emergency department visits, over 1,699,500 outpatient visits and the region's only Level I Trauma Center, Dartmouth-Hitchcock Medical Center includes: Mary Hitchcock Memorial Hospital, Dartmouth-Hitchcock Clinic, Dartmouth Medical School, the Veterans Affairs Medical Center in White River Junction, VT., Norris Cotton Cancer Center (a National Cancer Institute-designated Comprehensive Cancer Center), Children's Hospital at Dartmouth (CHaD) and more than 50 outpatient clinics and practices.
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, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that the positive results and clinical outcomes presented by Dartmouth-Hitchcock Medical Center will be repeated at other hospitals, 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 quarter ended March 29, 2008, filed with the Securities and Exchange Commission on May 1, 2008. 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. 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 quarter ended March 29, 2008, whether as a result of new information, future events or otherwise, except as may be required under the federal 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 Receives FDA Clearance for Noninvasive Total Hemoglobin
Irvine, California – May 14, 2008 – Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion-and-Low-Perfusion pulse oximetry, today announced it has received FDA clearance for its breakthrough noninvasive and continuous total hemoglobin monitoring technology (SpHb™). The availability of Masimo SpHb technology should make hemoglobin measurement more convenient and broadly available to clinicians in both hospital and outpatient settings—helping them make earlier and better clinical decisions, improve patient safety and decrease costs. Noninvasive total hemoglobin will be offered as part of the upgradable Masimo Rainbow SET technology platform.
Ronald Miller, MD, Professor and Chair of the Department of Anesthesia and Perioperative Care at the University of California at San Francisco (UCSF) stated, "Management of appropriate blood levels is vitally important to sustain life. Without up-to-date hemoglobin levels, patient bleeding in the operating room, recovery room, intensive care or trauma departments—where blood loss is common—can often go undetected until it poses critical short and long-term dangers to health and recovery. The ability to immediately and continuously measure hemoglobin levels will facilitate the timely administration of appropriate blood products. Conversely, during surgery, because blood is a precious and costly resource, continuously measuring hemoglobin levels noninvasively can help clinicians avoid unnecessary blood transfusions and decrease costs by more effectively titrating blood and blood replacement products."
Joe E. Kiani, Chairman and CEO of Masimo, said, "Developing breakthrough technologies that enhance patient safety and automate patient care is a responsibility that we take seriously. With noninvasive hemoglobin as part of the upgradable Masimo Rainbow SET platform, we are proud to be revolutionizing the way clinicians can assess anemic status and make more timely decisions that affect millions of patients worldwide."
The need for better hemoglobin monitoring to manage blood levels is reinforced by recently published controlled studies that show the safety of blood transfusions can be improved by the use of transfusion thresholds. In a 2008 study by the Cochrane Collaboration titled Transfusion Thresholds and Other Strategies for Guiding Allogeneic Red Blood Cell Transfusion, reviewers examined evidence from ten trials—reporting outcomes on a total of 1,780 patients—and found that "restrictive transfusion strategies reduced red blood cell transfusions by 42%."
Additionally, while noting that not all of these results were statistically significant and that additional studies are required to confirm the findings, the Cochrane reviewers also reported that, "on average, mortality was 20% lower with the restrictive compared with the liberal transfusion triggers." Similarly, five of the ten studies examined showed a reduction in hospital length of stay, while three showed a reduction in ICU length of stay.1
Continuous, noninvasive hemoglobin monitoring with Masimo Rainbow SET SpHb may enable more restrictive transfusion triggers and help maintain optimal hemoglobin levels for critically-ill patients. In addition to facilitating better blood level management, Masimo Rainbow SET's noninvasive hemoglobin monitoring capability should also help clinicians better manage chronic anemia, a blood disorder affecting two billion people worldwide that is one of today's most prevalent public health problems. Masimo Rainbow SET SpHb should provide hospitals, emergency medical professionals, dialysis centers, family physicians, cardiologists, pediatricians and other care providers with a more convenient and accessible way to manage this pervasive condition.
More than 350 million invasive hemoglobin lab tests are performed each year in the U.S. alone, making it one of the most common laboratory tests. Hemoglobin lab tests are costly, time-consuming and require that clinicians use a needle to draw a patient's blood—however, they only provide delayed and intermittent data. Masimo's SpHb technology requires no invasive procedures and provides continuous, real-time, pain-free results. This should allow clinicians to perform fewer lab tests, better manage blood transfusions and hemodialysis procedures, speed detection of internal bleeding, and more efficiently assess chronic anemia—all of which should help improve patient outcomes and reduce the cost-of-care.
"No other technology can provide continuous, noninvasive hemoglobin measurements," stated Michael O'Reilly, MD, Executive Vice President of Medical Affairs at Masimo. "Masimo Rainbow SET SpHb has the potential to revolutionize the management of both acute and chronic anemia, as well as the therapeutic interventions used to treat these conditions. We believe SpHb will provide a significant advancement in patient safety for clinicians worldwide."
The Masimo Rainbow SET platform allows clinicians to noninvasively and continuously measure oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI™ and total hemoglobin (SpHb™), in addition to oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR). Masimo anticipates commercial availability for both SpHb and SpOC in Q3 2008 to select 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, 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 www.masimo.com.
Forward Looking Statements This press release may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that Masimo's new noninvasive measurements—total hemoglobin (SpHb™) and oxygen content (SpOC™)—will deliver a sufficient level of clinical improvement over alternative hemoglobin measurement capabilities to allow for rapid adoption of the technology and risks related to our assumptions regarding the timing or commercial availability of SpHb and SpOC, as well as other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended March 29, 2008, filed with the Securities and Exchange Commission on May 1, 2008. 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. 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 quarter ended March 29, 2008, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
1 Hill SR, Carless PA, Henry DA, Carson JL, Herbert PC, McClelland DBL, Henderson KM. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database of Systematic Reviews 2000, Issue 1. Art. No.: CD002042. DOI: 10.1002./14651858.CD002042.
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.
Saint Barnabas Medical Center Converts to Masimo SET Technology – Establishing a Foundation for the Future of Pulse Oximetry
Hospital-wide conversion achieves technology and sensor standardization, creates process efficiencies and reduces costs
Irvine, California—May 9, 2008 -- Saint Barnabas Medical Center and Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion Pulse Oximetry, have announced the completion of Saint Barnabas Medical Center's hospital-wide implementation of Masimo SET pulse oximetry. The New Jersey-based hospital performed an extensive comparison and thorough evaluation spanning virtually every department and cited superior performance, technology capabilities and future clinical application as chief reasons for converting to Masimo SET.
"The decision to convert to Masimo SET pulse oximetry was multifaceted, with numerous benefits that we didn't think were possible in one technology," said Shyan Sun, M.D., Director of Neonatology, Saint Barnabas Medical Center. "With Masimo, we now have a standardized technology for oximetry that not only enables sensor consistency and standardization across departments at reduced costs, but also provides the system compatibility necessary to track oximetry inventory and costs – all in a technology platform that is uniquely expandable to support our current and future oximetry needs."
Saint Barnabas Medical Center is the flagship of the Saint Barnabas Health Care System, New Jersey's largest integrated health care delivery system, and ranks among the top 5 percent of all hospitals in the country. The 601-bed institution treats more patients annually and delivers more babies than any other facility in New Jersey, including more than 40,000 inpatients admissions, over 65,000 Emergency Department visits, and nearly 7,000 births each year. Additionally, the Medical Center and its Ambulatory Care Center provide treatment and services for more than 300,000 outpatient visits annually. The Saint Barnabas Health Care System includes six acute care hospitals, a behavioral health center, ambulatory care facilities, eight nursing and rehabilitation centers, an assisted living facility, geriatric centers, a state-wide behavioral health network, and comprehensive home care and hospice programs.
Prior to their conversion, Saint Barnabas had a handful of various oximetry monitors and technologies that each required different sensors from different vendors—eliminating the ability to purchase sensors in combined volume. On top of this, these varying technologies were incompatible with the hospital's inventory management program software and could not provide usable data to track inventory movement and oximetry costs. Converting to Masimo SET pulse oximetry helped Saint Barnabas Medical Center to overcome these challenges, while reducing costs and creating process efficiencies that help to improve the process of care.
In addition to Saint Barnabas's hospital-wide standardization to Masimo SET pulse oximetry, the conversion also allows Saint Barnabas clinicians to utilize Masimo Rainbow SET technology – an upgradable noninvasive blood constituent monitoring platform that is capable of measuring additional blood constituents that previously could only be measured with invasive procedures. Masimo Rainbow SET is the first and only method to continuously and noninvasively measure total hemoglobin (SpHb™) and oxygen content (SpOC™) (both pending regulatory clearances), carboxyhemoglobin (SpCO) and methemoglobin (SpMet), in addition to oxyhemoglobin (SpO2), perfusion index (PI), pleth variability index (PVI) and pulse rate. Developed as a scalable and upgradeable technology platform, Masimo Rainbow SET enables clinicians and hospitals to do more with their Masimo devices by building and expanding the noninvasive measurements, capabilities and features within the platform. This allows hospitals to make an investment in patient safety today that won't become obsolete tomorrow.
By making the conversion to Masimo, Saint Barnabas joins many of the top hospitals in the United States—including four of the top five—as listed on the US News & World Report Honor Roll, which have all adopted Masimo SET as their primary pulse oximetry platform. Clinically proven in more than 100 independent and objective studies, Masimo SET provides the most trustworthy SpO2 readings, even under the most difficult clinical conditions, including patient motion and low peripheral perfusion. These studies demonstrate that Masimo SET delivers improvements in outcomes, safety and efficiency.
Joe E. Kiani, CEO of Masimo, stated, "Saint Barnabas Medical Center's conversion to Masimo SET pulse oximetry ensures they have the best of the present and are set for the future with the upgradeable Masimo Rainbow SET technology platform. They represent a growing industry trend toward pulse oximetry technologies that have value and relevance into the future. Masimo Rainbow SET is the first pulse oximetry technology platform to pioneer this capability and the only one that can provide the innovation to drive this proposition for hospitals worldwide. We value Saint Barnabas for their commitment to patient care, quality and this vision."
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, 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™) and oxygen content (SpOC™) (both pending regulatory clearances), 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: 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 systems to allow for further adoption of the technology at other hospitals, risks related to our assumption that this agreement with Saint Barnabas will serve to substantially increase revenues, and risks related to our assumption that Masimo's new noninvasive measurements—total hemoglobin (SpHb™) and oxygen content (SpOC™)—will deliver a sufficient level of clinical improvement over alternative hemoglobin testing capabilities to allow for rapid adoption of the technology and risks related to our assumptions regarding the timing or commercial availability of SpHb and SpOC, and will be timely cleared, if ever, by appropriate regulatory bodies, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-Q for the quarter ended March 29, 2008, filed with the Securities and Exchange Commission on May 1, 2008. 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. 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-Q for the quarter ended March 29, 2008, whether as a result of new information, future events or otherwise, except as may be required under the federal 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, SpCO, SpMet, PVI, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo Showcases Best-in-Class Patient Safety Solutions at the AACN Conference
Masimo introduces the new Rad-87 Pulse CO-Oximeter, Patient SafetyNet, and noninvasive hemoglobin
Irvine, California—May 6, 2008 -- Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion Pulse Oximetry, will showcase the latest technology for patient safety solutions at the American Association of Critical Care Nurses (AACN), National Teaching Institute (NTI) & Critical Care Exposition in Chicago on May 6-8, 2008. Live demonstrations of the new Masimo Rad-87 Pulse CO-Oximeter™, Masimo Patient SafetyNet™ and continuous, noninvasive hemoglobin (SpHb™) (pending FDA clearance) will show how Masimo technologies can help critical care clinicians advance patient safety, improve patient outcomes, and increase clinical efficiencies.
This year, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, recognized improved recognition and response to changes in a patient's condition as one of their key National Patient Safety Goals.
A key foundational component to improving patient safety on the general floor is the unprecedented sensitivity and specificity of Masimo SET pulse oximetry. Before Masimo SET, pulse oximeters were reported to falsely alarm more than 90% of the time. In fact, one major hospital attempted to monitor patients on the general floor before the advent of Masimo SET and reported thousands of false alarms per month.
Another key component to improving clinician response to changing patient conditions on the general care floor is Masimo Patient SafetyNet—a new easy-to-use remote monitoring and clinician notification system that reliably and cost-effectively delivers patient alarms to assigned clinicians. Combining the "gold standard" performance of Masimo SET® pulse oximetry with wireless clinician notification via pager, Patient SafetyNet provides a new level of safety to patients on general care floors.
A perfect complement to Masimo SET and Patient SafetyNet is the new Masimo Rad-87 bedside monitor. The Rad-87 is an easy-to-use, yet fully-featured Pulse CO-Oximeter with a built-in 802-11a/b/g radio for bidirectional wireless communication with the Patient SafetyNet system. Recently cleared by the FDA, it features a simple, intuitive user-interface design with an easy-to-read, high-contrast display that allows clinicians to clearly see the Masimo Rainbow SET measurements—even from across the room. Alarms and alerts can be enabled at the bedside or remotely, via the Patient SafetyNet system. Rad-87 allows activation of many features with only a single touch and its unique visual display allows users to quickly confirm if the alarm settings are appropriate for the patient environment.
Rad-87 also features Masimo Rainbow SET, the first-and-only noninvasive blood constituent monitoring platform measuring carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI™, in addition to oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate. A cost-effective solution for critical care customers who value ease-of-use and versatility, Rad-87 will also be capable of displaying Masimo's newest Rainbow measurement—noninvasive total hemoglobin (SpHb™) (pending FDA clearance).
As the Anesthesiology Patient Safety Foundation (APSF) has recommended, continuous monitoring of oxygenation (pulse oximetry) and ventilation should reduce the incidence of preventable postoperative death and injury on the general care floors.1 Rad-87 and Patient SafetyNet should help hospitals provide the level of care their patients on the general floors need without the burden of excessive false alarms on their already stretched resources.
In addition, Rad-87's ability to provide noninvasive and continuous hemoglobin monitoring should help improve patient outcomes and reduce the cost of care by providing real-time anemia monitoring—potentially allowing clinicians to perform fewer lab tests, better manage blood transfusions, speed detection of internal bleeding, and more efficiently assess chronic anemia.
Joe E. Kiani, CEO of Masimo, stated, "Masimo has had a longstanding commitment to 'do what is best for patient care' through innovation. The new Rad-87, Patient SafetyNet and Rainbow SET technologies that we are presenting to the critical care community at the AACN underscore our commitment and highlight our continued focus on developing innovative monitoring solutions to empower healthcare professionals to provide more advanced and comprehensive care to their patients."
Sponsored by the American Association of Critical Care Nurses, the NTI & Critical Care Exposition is the largest and most comprehensive trade show for acute and critical care nurses.
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, 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™) and oxygen content (SpOC™) (both pending regulatory clearances), 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that Masimo Patient SafetyNet, Rad-87, Masimo SET and Masimo Rainbow SET technologies will deliver a sufficient level of clinical improvement to allow for further adoption of pulse oximetry or Pulse CO-Oximetry on the general care floors and risks related to our assumption that Masimo's new noninvasive measurements—total hemoglobin (SpHb™) and oxygen content (SpOC™)—will deliver a sufficient level of clinical improvement over alternative invasive testing capabilities to allow for rapid adoption of the technology and risks related to our assumptions regarding the timing or commercial availability of SpHb and SpOC, and will be timely cleared, if ever, by appropriate regulatory bodies, as well as other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended March 29, 2008, filed with the Securities and Exchange Commission on May 1, 2008. 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. 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 quarter ended March 29, 2008, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
1 Anesthesia Patient Safety Foundation (ASPF) Initiatives: "Safety During Patient-Controlled Analgesia"; October 13, 2006. www.apsf.org/initiatives/pca.mspx
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, 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 will preview the new Masimo Rad-87 at this year's NTI. The Rad-87 is an easy-to-use, yet fully-featured Pulse CO-Oximeter with a built-in 802-11a/b/g radio for bidirectional wireless communication with the Patient SafetyNet system.
Masimo to Present at Deutsche Bank 33rd Annual Health Care Conference
Irvine, California, May 1, 2008 – Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry-and-Measure-Through-Motion-and-Low-Perfusion pulse oximetry, today announced that it is scheduled to present at the Deutsche Bank 33rd Annual Health Care Conference at the InterContinental Boston in Boston, MA on Tuesday, May 6, 2008 at 9:30 a.m. ET. Joe E. Kiani, Chairman will be presenting.
A live Web cast of the presentation will be available on the Masimo Web site at www.masimo.com. A replay of the Web cast 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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most difficult 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™) and oxygen content (SpOC™) (both pending FDA clearance), carboxyhemoglobin (SpCO®), methemoglobin (SpMet® ), and pleth variability index (PVI™), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate, 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, SpCO, SpMet, PVI, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo Reports First Quarter 2008 Financial Results
Record results mark 19th consecutive quarter of revenue growth
Q1 2008 Highlights:
Product revenues increased 30% to a record $59.7 million
Shipped 28,600 new pulse oximeters
Rainbow revenues increased 104%
Irvine, California, April 29, 2008 – 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 2008 first quarter ended March 29, 2008.
For the first quarter of 2008, Masimo reported product revenues of $59.7 million representing a 30% increase over $45.8 million for the first quarter of 2007. Including royalty revenues, Masimo reported total 2008 first quarter revenues of $71.1 million compared to $59.0 million for the first quarter of 2007. Net income for the 2008 first quarter was $8.8 million representing $0.15 per common share compared to $9.1 million or $0.11 per common share for the first quarter of 2007.
Masimo also reported that it shipped 28,600 Masimo SET and Masimo Rainbow SET oximetry units, excluding handheld units, during the first quarter of 2008. This represented an 8% increase from 26,500 units in the comparable prior year period, resulting in a new estimated net worldwide installed base of 491,000 Masimo SET pulse oximeters.
Joe E. Kiani, Chairman and Chief Executive Officer of Masimo, said, "We are happy to report first quarter results that once again exceeded expectations. We believe that these results reflect the increasing momentum for the clinical adoption of our life saving Masimo SET and Masimo Rainbow SET technologies. In fact, in the first quarter of 2008, demand for our new Masimo Rainbow SET technologies, on the strength of our Rad-57 handheld carbon monoxide measuring device, increased over 100% compared to Q1 last year."
Cash and cash equivalents totaled $86.3 million at March 29, 2008. Masimo also reported that during the 2008 first quarter, it satisfied in full a $26.7 million debt obligation, the majority of which was originally established in early fiscal 2007.
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 (866) 831-6247 for domestic callers and (617) 213-8856 for international callers. The reservation number for both dial-in numbers is 82345350. 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 web site through May 29, 2008. In addition, a telephonic replay of the call will be available until May 13, 2008. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. Please use reservation code 71776300.
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, 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™) and oxygen content (SpOC™) (both pending regulatory clearances), 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. 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; the market acceptance of our technologies and products; the value of measuring new parameters; expectations regarding our ability to design and deliver innovative new noninvasive technologies; and expectations for total revenues, product revenues, GAAP earnings per share, non-GAAP pro forma earnings per share and stock based compensation expenses for the full fiscal year 2008. 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 from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our reliance on Masimo SET and related 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; the 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 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 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 Annual Report on Form 10-K for the fiscal year ended December 29, 2007 filed with the Securities and Exchange Commission on March 4, 2008. 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 the date hereof. 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 December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the 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.
Masimo to Report First Quarter 2008 Financial Results on April 29, 2008
Conference call and webcast with Masimo CEO and CFO to begin after markets close at 2:00 p.m. PT (5:00 p.m. ET)
IRVINE, Calif., April 18, 2008—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 financial results for the period ended March 29, 2008 after the market closes on Tuesday, April 29, 2008.
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 & 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 (866) 831-6247 for domestic callers and (617) 213-8856 for international callers. The reservation number for both dial-in numbers is 82345350. After the live webcast, the call will remain available on Masimo's web site through May 29, 2008. In addition, a telephonic replay of the call will be available until May 13, 2008. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. Please use reservation code 71776300.
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, 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™) and oxygen content (SpOC™) (both pending regulatory clearances), 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.
Investor Contact: Mark P. de Raad Executive Vice President and Chief Financial Officer (949) 297-7080 mderaad@masimo.com
Media Contact: Dana Banks 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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Atom Medical Adopts Masimo Rainbow SET Technology
Irvine, California – April 16, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, today announced an agreement with Atom Medical Corporation, a leading global manufacturer of neonatal products and technologies, to integrate Masimo Rainbow SET Pulse CO-Oximetry into its current and future product solutions.
"Since standardizing on Masimo technology more than 10 years ago, our neonatal monitoring solutions and customers have greatly benefited from the superior performance of Masimo SET pulse oximetry," said Kazuo Matsubara, President of Atom Medical. "Now, with the groundbreaking capabilities of Masimo Rainbow SET and its ability to provide vital measurements that previously required invasive lab procedures, we are confident that the clinical community which we serve will experience even greater clinical and financial benefits from our solutions."
Masimo Rainbow SET is the first and only technology platform capable of noninvasively and continuously measuring total hemoglobin (SpHb™) and oxygen content (SpOC™)—both measurements pending FDA and other regulatory clearances—as well as carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and pleth variability index (PVI™), in addition to oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).
Masimo Rainbow SET has the potential to help clinicians save lives through more rapid diagnosis of potentially life-threatening conditions, allowing faster treatment decisions and improved patient outcomes. The latest Masimo Rainbow SET measurement, SpHb, may enable medical personnel in both hospital and outpatient settings to quickly identify anemia or blood loss without having to draw blood or wait for lab results.
In neonatal settings, the ability to continuously and noninvasively measure a patient's methemoglobin levels is especially important due to the risks associated with the use of inhaled nitric oxide (iNO) therapy to treat hypoxic respiratory failure in newborns, which has been shown to induce methemoglobinemia. According to the American Academy of Pediatrics, "infants who receive iNO therapy should be monitored according to institutionally derived protocols designed to avoid the potential toxic effects associated with iNO administration. These effects include methemoglobinemia (secondary to excess nitric oxide concentrations), direct pulmonary injury (attributable to excess levels of nitrogen dioxide), and ambient air contamination." 1
Masimo Chairman and CEO, Joe E. Kiani, said, "Atom is a long-time Masimo partner dedicated to developing innovative solutions for the challenging neonatal clinical setting. The addition of Masimo Rainbow SET affirms their position as a leading global provider of advanced neonatal product solutions, leveraging breakthrough technologies to improve the quality of care for the tiniest of patients. We commend Atom for their commitment to patient care and product innovation."
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, 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™) and oxygen content (SpOC™) (both pending regulatory clearances), 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that this agreement with Atom and their adoption of Masimo technology will serve to substantially increase revenues, risks related to our assumption that Masimo's new noninvasive measurements—total hemoglobin (SpHb™) and oxygen content (SpOC™)—will deliver a sufficient level of clinical improvement over alternative hemoglobin testing capabilities to allow for rapid adoption of the technology and risks related to our assumptions regarding the timing or commercial availability of SpHb and SpOC, and will be timely cleared, if ever, by appropriate regulatory bodies, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 29, 2007, filed with the Securities and Exchange Commission on March 4, 2008. 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. 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 year ended December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
1 AMERICAN ACADEMY OF PEDIATRICS: Pediatrics, Vol. 106 No. 2 August 2000, pp. 344-345, Use of Inhaled Nitric Oxide, Committee on Fetus and Newborn.
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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo PVI™ Cleared for Market in Japan
PVI could help clinicians assess a patient's fluid responsiveness noninvasively, according to a new study published in "Anesthesia & Analgesia"
Irvine, California - April 3, 2008 - Masimo, the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced Japanese Ministry of Health, Labor and Welfare (MHLW) approval of its PVI measurement. PVI is an index automatically derived from the Masimo plethysmographic waveform, which has been demonstrated to noninvasively assess fluid responsiveness in mechanically ventilated patients and can help clinicians assess if a patient's cardiac function is compromised.
PVI may help clinicians and emergency professionals to determine if a patient is dehydrated or over-hydrated—enabling more accurate fluid administration decisions—all by simply referring to the numerical Masimo PVI value that is continuously displayed on Masimo Rainbow SET Pulse CO-Oximeters. With one noninvasive sensor, Masimo Rainbow SET technology delivers multiple physiologic measurements that previously required invasive blood tests, including total hemoglobin (SpHb™) and oxygen content (SpOC™) (both pending FDA and other regulatory clearances), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI™, oxyhemoglobin (SpO2), perfusion index and pulse rate.
During surgery and post-operatively, the immediate identification and rapid intervention of patients who are most likely to respond to fluid administration (fluid responders) can enable organ preservation, while recognizing patients unlikely to respond to fluid administration (fluid non-responders) can prevent pulmonary edema. Clinical studies have shown that current static methods for assessing fluid responsiveness, including clinical examination, arterial blood pressure, heart rate and central venous and pulmonary artery occlusion pressure, are poor predictors of fluid responsiveness. Also dynamic indices, such as respiratory variations in arterial pulse pressure, inferior vena cava diameter, superior vena cava diameter and stroke volume, present significant limitations, are invasive and often operator-dependent.
PVI is a dynamic new indicator of fluid responsiveness that does not require an invasive procedure or manual calculation, yet has been demonstrated to be sensitive to changes in preload and to be an accurate predictor of fluid responsiveness in mechanically ventilated patients.
In this month's Anesthesia and Analgesia Journal, a clinical study titled, "Does the Pleth Variability Index (PVI) Indicate the Respiratory-Induced Variation in the Plethysmogram and Arterial Pressure Waveforms?" headed by Dr. Maxime Cannesson from the Louis Pradel Hospital and the Claude Bernard Lyon University in Lyon, France, studied 25 patients under general anesthesia and mechanical ventilation and found a strong correlation between Masimo's PVI measurement and the manually measured Delta POP (r=0.92), with a sensitivity of 93% and a specificity of 97%. The researchers had previously shown a high correlation between Delta POP and fluid responsiveness. The recent study findings also confirmed that the relationship between PVI and Delta POP was still significant when performed in the Anti-Trendelenburg (r=0.94) and Trendelenberg (r=0.93) body positions, illustrating the responsiveness of PVI to the dynamic and changing fluid volume status. Dr. Cannesson et al. concluded that PVI has "potential clinical applications for noninvasive fluid responsiveness monitoring." 1
"PVI should provide clinicians with the most effective and efficient noninvasive method of continuously measuring their patient's fluid volume," stated Michael O'Reilly, MD, EVP of Medical Affairs at Masimo. "The addition of PVI in Masimo pulse oximeters now available in Japan should help clinicians in Japan add a level of certainty and immediacy toward balancing and managing intravascular fluid volumes and cardiac output both inside and outside of the operating room."
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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most difficult 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™) and oxygen content (SpOC™) (both pending FDA and other regulatory clearances), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI™, in addition to oxyhemoglobin (SpO2), perfusion index and pulse rate, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that PVI will prove to be an effective clinical indicator of patient hydration and the need for fluid loading, that the findings in the study referred to herein will be replicated in future studies, that approval of PVI by the Japanese MHLW will serve to materially increase Masimo product sales or revenues targets for 2008, and assumptions related to the development of products and technologies that may compete with PVI, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 29, 2007, filed with the Securities and Exchange Commission on March 4, 2008. 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. 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 year ended December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
1 Does the Pleth Variability Index Indicate the Respiratory Induced Variation in the Plethysmogram and Arterial Pressure Waveforms? Maxime Cannesson, MD, Bertrand Delannoy, MD, Antoine Morand, MD, Pascal Rosamel, MD, Yassin Attof, MD, Olivier Bastien, MD, PhD, Jean-Jacques Lehot, MD, PhD. Department of Anesthesiology and Intensive Care, Louis Pradel Hospital and Claude Bernard Lyon University, Lyon, France. Anesthesia & Analgesia. Vol. 106. No. 4. April 2008.
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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Contact: Dana Banks Masimo Corporation 949-297-7348
Schiller AG Adopts Masimo Rainbow SET as their Technology Platform of Choice for Patient Monitoring Devices Worldwide
Irvine, California – March 25, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, today announced an agreement with Switzerland-based Schiller, a leading European manufacturer and supplier of electrocardiographs, spirometers, patient monitors and external defibrillators, to integrate the Masimo Rainbow SET technology platform as the foundational technology of choice for all their patient monitoring solutions worldwide.
Masimo Rainbow SET, an upgradeable noninvasive technology platform featuring the accuracy and reliability of Masimo SET Measure-Through Motion and Low Perfusion pulse oximetry, is revolutionizing patient monitoring by significantly expanding pulse oximetry's ability to capture, track and monitor blood constituents that previously required invasive procedures. The first and only technology platform capable of continuously and noninvasively measuring total hemoglobin (SpHb™) and oxygen content (SpOC™) (both pending FDA clearance), in addition to carboxyhemoglobin (SpCO™), methemoglobin (SpMet™), pleth variability index (PVI™), oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate—Masimo Rainbow SET is helping to advance patient safety and improve care worldwide.
"Our leading position in the world market is based on a history of implementing new technologies and innovative first-class solutions that create long-term value for our customers and their patients," said Schiller AG CEO, Alfred Schiller. "Masimo understands the importance of cutting-edge technologies in our market and has combined the most advanced noninvasive technology and capabilities with the best user benefits available into a technology platform that maximizes long-term value."
The ability to quickly and continuously measure SpHb, SpOC, SpMet, SpCO, PVI, SpO2, PR, and PI noninvasively may help clinicians to save lives by more rapidly diagnosing potentially life-threatening conditions, speeding treatment decisions and improving patient outcomes. SpHb may make hemoglobin testing quick, convenient and accessible to medical personnel in both acute and outpatient settings—enabling them to quickly identify conditions of anemia, or blood loss. The availability of real-time continuous SpOC may help to ensure optimal oxygen delivery in patients during rapidly-changing clinical situations.
By continuously and noninvasively monitoring SpMet, clinicians can accurately determine if drugs they are administering are causing methemoglobinemia, which can lead to brain damage and even death. Similarly, the ability to measure SpCO allows clinicians to detect elevated levels of carboxyhemoglobin that can be caused by everything from desiccated soda lime (known as "Monday Morning Phenomena"), or other poisons that can be introduced during surgery, to smokers reporting for surgery with high SpCO values. Increased SpCO compromises healing and may lead to death, while smokers with residual elevated COHb at the time of anesthesia are at cardiac ischemic risk. PVI provides clinicians with a continuous and noninvasive quantified measurement of changes in the perfusion index – indicating a change in a patient's physiologic condition, which may compromise cardiac function and affect systemic circulation – with potential clinical applications for noninvasive hypovolemia detection and fluid responsiveness monitoring.
"Establishing Masimo Rainbow SET as the technology engine for Schiller's patient monitoring, emergency medicine and rescue solutions enables us to provide a dynamic new set of clinical capabilities that expand the physiological data and options available to clinicians and caregivers – allowing them to better care for their patients," stated Dominik Doppler, VP, Marketing, Sales and Business Development at Schiller. "This is a compelling value proposition for the global healthcare market."
At the heart of Masimo Rainbow SET is the world's most accurate and reliable pulse oximetry technology – Masimo SET. More than 100 independent and objective studies demonstrate that Masimo SET provides the most trustworthy SpO2 and pulse rate measurements even under the most difficult clinical conditions, including patient motion and low peripheral perfusion. Before the introduction of Masimo SET in 1995, pulse oximetry was reliable only when patient conditions were ideal—on motionless patients with strong pulses and good perfusion. However, in the presence of patient motion, a weak pulse or low perfusion, excessive false alarms reduced the value of conventional pulse oximetry. Since then, Masimo SET Measure-Through Motion and Low Perfusion pulse oximetry has made continuous, noninvasive monitoring by pulse oximetry more reliable and clinically-relevant than ever before.
Joe E. Kiani, Chairman and CEO of Masimo, stated "Schiller has been a long-term partner with us and was one of the early-adopters of Masimo SET technology. Once again, as an early-adopter of Masimo Rainbow SET technology, Schiller represents a growing global community of Original Equipment Manufacturers (OEMs) who are embracing and standardizing to Masimo Rainbow SET as the noninvasive patient monitoring technology of the future. They are market leaders and global champions for innovation, patient safety and quality of care who make the world safer for patients everywhere. We appreciate the vision, leadership and commitment of Schiller and we are proud of our partnership."
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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most difficult 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™) and oxygen content (SpOC™) (both pending FDA clearance), carboxyhemoglobin (SpCO™), methemoglobin (SpMet™), and pleth variability index (PVI™), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that this agreement with Schiller and their adoption of Masimo technology will serve to substantially increase revenues, risks related to our assumption that Masimo's new noninvasive measurements—total hemoglobin (SpHb™) and oxygen content (SpOC™)—will deliver a sufficient level of clinical improvement over alternative hemoglobin testing capabilities to allow for rapid adoption of the technology and risks related to our assumptions regarding the timing or commercial availability of SpHb and SpOC, and will be timely cleared, if ever, by appropriate regulatory bodies, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 29, 2007, filed with the Securities and Exchange Commission on March 4, 2008. 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. 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 year ended December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal 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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
New Study Finds Masimo Rainbow SET Pulse CO-Oximetry™ Effective as a Universal Screening Tool to Identify Cases of Unsuspected CO Poisoning in ERs
Rhode Island Hospital study identifies 11 cases of unsuspected CO poisoning through universal CO screening with the Masimo Rad-57 Pulse CO-Oximeter™
Irvine, California—March 19, 2008 – Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion & Low Perfusion Pulse Oximetry, reported that a new clinical study, recently published in the Journal of Emergency Medicine, found the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to be "a safe, easily applied tool at triage that can identify cases of unsuspected elevated levels of carbon monoxide (CO) poisoning" that would otherwise have gone undetected.
Researchers at the Rhode Island Hospital, where the study was conducted, also concluded that universal SpCO® screening may prevent morbidity through early identification and treatment intervention, stating that: "we can point to several cases during our study period in which patient outcomes were different based upon availability of SpCO, recorded at triage."
The study titled "Noninvasive Pulse CO-Oximetry Screening in the Emergency Department Identifies Occult Carbon Monoxide Toxicity" was conducted over a nine-month period on more than 10,850 patients presenting to the Emergency Department at the Rhode Island Hospital in Providence, Rhode Island, by a research team of emergency medicine physicians from the Warren Alpert Medical School at Brown University and the Emergency Department of Rhode Island Hospital, headed by Dr. Selim Suner.
In this study, Dr. Suner, Dr. Jay, Dr. Partridge, Dr. Sucov, Dr. Valente, Dr. Chee and Dr. Hughes tested the ability to screen for CO toxicity in a busy tertiary center ED using the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter and found 28 cases of CO toxicity (SpCO of > 9% for nonsmokers and >13% for smokers), of which 11 were unexpected, and were identified only with the aid of universal SpCO screening using the Masimo Rad-57. In all CO toxicity cases identified, venous or arterial COHb confirmations of elevated SpCO measurements were verified by lab analysis of blood samples taken with data results showing a "good correlation" between SpCO from the Masimo Rad-57 and COHb from the lab analysis.
The research team noted that identification of CO toxicity in the ED is often challenging because many patients may not know or suspect that they were exposed to CO and are unable to provide clinicians with sufficient history to prompt testing for carboxyhemoglobin (COHb). In addition, the symptoms of CO poisoning can be similar to the flu. However, missing the opportunity to diagnose CO poisoning at the ED because screening large populations of patients by invasive blood testing for CO toxicity is not practical and not routinely performed in the ED setting can lead to "inadvertently returning a patient to the site of CO exposure and may lead to further toxicity with the possibility of long-term neurological, psychiatric, or cardiovascular complications."
Using data extrapolated from the study at Rhode Island Hospital's level-1 trauma center ED, researchers suggest that potentially "as many as 11,000 occult poisoning cases" go undetected annually—illustrating the significant impact that universal SpCO screening could have on public health and safety. "Screening will also protect the public by identifying hidden sources of CO in households, workplaces and schools," said researchers.
Joe E. Kiani, Chairman and CEO of Masimo, stated: "The researchers at Rhode Island Hospital have done a great public service in addressing the benefits of routine, universal screening by Pulse CO-Oximetry upon admission in emergency departments. As this study has shown, the importance of diagnosing unsuspected CO poisoning at emergency departments nationwide could mean a big difference in the lives of the estimated 11,000 people each year who may be suffering in silence as CO ravages their health."
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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most difficult 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™) and oxygen content (SpOC™) (pending FDA clearance), carboxyhemoglobin (SpCO™), methemoglobin (SpMet™), and pleth variability index (PVI™), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter will be an effective universal screening tool at all EDs and risks related to our assumption that Masimo Pulse CO-Oximetry technology will deliver a sufficient level of clinical improvement over alternative carbon monoxide screening methods to allow for rapid adoption of the technology in hospital and emergency medicine environments, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 29, 2007, filed with the Securities and Exchange Commission on March 4, 2008. 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. 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 year ended December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal 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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
University of Michigan Hospitals and Health Centers Completes System-Wide Conversion to Masimo SET Pulse Oximetry Technology
Conversion helps U-M Hospitals and Health Centers, named one of America's best hospitals by U.S. News & World Report, make clinical practice changes to improve patient safety
Irvine, California – March 12, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced the completion of the University of Michigan (U-M) Hospitals and Health Centers system-wide implementation of Masimo SET pulse oximetry. Leaders at the institution cited superior clinical performance as the chief reason for conversion to Masimo SET as their standard of care for precise, continuous SpO2 monitoring.
Kevin K. Tremper, MD, Chairman of Anesthesiology at the U-M Hospitals and Health Centers, said, "Our evaluations of Masimo SET alongside other pulse oximetry technologies provided clinical staff with the opportunity to objectively appraise the performance of each of these pulse oximetry devices and we found the Masimo device to be superior."
Nationally recognized as one of the top healthcare organizations in the country and one of only 18 hospitals included in the U.S. News & World Report Best Hospitals Honor Roll, the U-M Hospitals and Health Centers is a 913-bed healthcare system encompassing three hospitals—University Hospital, C.S. Mott Children's Hospital and Women's Hospital—in addition to more than 30 health centers and 120 outpatient clinics.
Unlike conventional pulse oximeters, Masimo SET Measure-Through Motion and Low Perfusion pulse oximetry is new-generation technology that uses sophisticated signal processing technologies, including parallel engines and adaptive filters, to deliver accurate and reliable SpO2 and pulse rate measurements when conventional pulse oximetry technologies don't. As a result, Masimo SET provides the greatest sensitivity (ability to detect true positives) with the greatest specificity (ability to reject false positives). By delivering meaningful alarms and alerts that can be trusted to reflect a patient's true oxygenation status, clinicians can maximize their efficiency by concentrating on caring for their patients, rather than chasing false alarms.
The sensitivity and reliability of Masimo SET pulse oximetry technology can also provide an effective solution to address the clinical concerns associated with properly monitoring at-risk post-operative patients. Rising acuity levels—due predominately to aggressive post-operative pain management with patient-controlled analgesia (PCA) pumps and increased co-morbidities at admission—have dramatically increased incidents of avoidable adverse and sentinel events (events resulting in death or serious physical injury). In addition, undiagnosed Obstructive Sleep Apnea (OSA) can place patients at considerable respiratory risk as pain medications typically suppress the natural breathing reflex during apneic episodes. These clinical realities have significantly impacted the way in which clinicians deliver care.
"As a result of our new Masimo SET pulse oximetry capabilities, we have implemented a policy in which all patients receiving intravenous opioids for post-operative pain are monitored with Masimo SET oximeters networked to our nurse paging system," said Dr. Tremper. "We have found that this clinical practice change provides a workable solution to a challenging national clinical problem and, in addition to being well-received by our nursing staff, we feel it has improved patient safety within the U-M Health System. We are hoping to document and share our efforts in academic publications throughout the next year."
By making the conversion to Masimo, U-M Hospitals and Health Centers joins other top hospitals in the United States—including four of the top five, as listed on the U.S. News & World Report Honor Roll—that have all adopted Masimo SET as their primary pulse oximetry platform. More than 100 independent and objective studies demonstrate that Masimo SET provides the most trustworthy SpO2 readings even under the most difficult clinical conditions, including patient motion and low peripheral perfusion. These studies have shown that Masimo SET delivers improvements in outcomes, safety and efficiency.
Joe E. Kiani, CEO of Masimo, stated, "University of Michigan Hospitals and Health Centers provides numerous local and statewide community health programs and services that enable healthcare access for all. This system-wide conversion and standardization to Masimo SET pulse oximetry is an example of U-M's commitment to advancing pat
