![]()
Click here to view videos of Masimo in the news.
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 Forward Looking Statements 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: 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 Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, 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 Forward Looking Statements 1 Anesthesia Patient Safety Foundation (ASPF) Initiatives: "Safety During Patient-Controlled Analgesia"; October 13, 2006. www.apsf.org/initiatives/pca.mspx Contact: 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 Corporation Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpCO, SpMet, PVI, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation. |
|
Masimo Reports First Quarter 2008 Financial Results Record results mark 19th consecutive quarter of revenue growth Q1 2008 Highlights:
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 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 Forward-Looking Statements Masimo Corporation Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpCO, SpMet, PVI, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
|
|
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 Investor Contact: Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, 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 Forward Looking Statements Contact: 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 Forward Looking Statements 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. Contact: |
|
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 Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, 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 Forward-Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, 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 patient care and safety for all of its patients system-wide. We are delighted to be the pulse oximetry standard for U-M and their patients and are proud to provide a solution that supported their clinical practice change to help keep their post-operative patients monitored and safe." About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, and Pulse CO-Oximeters are trademarks or registered trademarks of Masimo Corporation. |
|
New Clinical Studies Presented at the 14th World Congress of Anesthesiology Demonstrate Masimo Advancements in Patient Care Noninvasive Hemoglobin Receives Rave Reviews from Attendees at Masimo's Commercial Exhibit Irvine, California – March 6, 2008 – Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, reported that multiple clinical studies demonstrating the accuracy and clinical effectiveness of the Masimo Rainbow SET platform were highlighted earlier this week to over 8,000 anesthesiologists at the 14th World Congress of Anesthesiology (WCA) in Cape Town, South Africa. In addition, WCA attendees from all over the world were able to preview noninvasive total hemoglobin (SpHb™) and oxygen content (SpOC™) as part of the Rainbow SET platform (pending FDA clearance). Clinical Study Highlights Continuous Noninvasive Measurement of Hemoglobin via Pulse CO-Oximetry1, a clinical study led by Dr. Mark Macknet at Loma Linda University in Loma Linda, California, presented a study that compared an engineering prototype of Masimo Rainbow SET noninvasive total hemoglobin (SpHb) to invasive laboratory hemoglobin measurements in two groups. Group one included 55 patients scheduled to undergo surgery, while group two consisted of 32 healthy volunteers undergoing a hemodilution protocol. After reviewing 1,538 data pairs, researchers found that the Masimo technology accurately delivered total hemoglobin levels, with the study showing accuracy of 1.28 g/dl and 0.94 g/dl for group two, respectively, when compared to invasive laboratory CO-Oximetry. Researchers concluded that Masimo's device is the "first device developed that can continuously and noninvasively measure hemoglobin concentration, in addition to the other common hemoglobin species, and therefore provides a significant expansion of existing physiologic monitoring technology." Casual Screening of Hemoglobin Noninvasively Positively Affects a Colleague's Future2, a case report by Dr. Martin Allard at Loma Linda University recounted the application of SpHb to assess an anemic hemoglobin level of 10.6 g/dl on a fellow anesthesiologist who otherwise appeared healthy. Invasive hemoglobin testing confirmed the measurement and further diagnostic testing revealed previously undiagnosed and asymptomatic esophageal cancer. Researchers concluded that Masimo SpHb allowed the "detection of this potentially devastating tumor before clinical signs or symptoms became apparent, which resulted in early intervention and therapy that may well be curative for this colleague." New Pulse Oximetry Sensors with Low Saturation Accuracy Claims3, performed by Dr. Peter Cox at the Hospital for Sick Children in Toronto, Canada, evaluated 12 patients with congenital cyanotic cardiac lesions (CCCL) to compare noninvasive oxyhemoglobin (SpO2) measurements from the Masimo Rainbow SET Radical 7 device with Blue Sensor and the Covidien N-600 device (OxiMax with Lo-Sat) to invasive oxyhemoglobin levels from laboratory CO-Oximetry. Although the Nellcor N-600 with LoSat is advertised to work in CCCL patients, the accuracy demonstrated in this study was 6.49%, well outside of Nellcor's published specifications. In contrast, the Masimo Radical with Blue Sensor, the first and only sensor with accuracy claims cleared for cyanotic patients, performed within Masimo specifications and had significantly better accuracy at 3.85%. Study results demonstrate that the Masimo Blue sensor, which was "designed for use specifically in this patient population, is more accurate." Dr. Peter Cox, Hospital for Sick Children in Toronto, Canada, said, "accurate monitoring of oxygen saturations in children with cyanotic congenital heart defects is essential for appropriate patient management and, therefore, its impact on their long-term outcome. The Masimo Blue Sensor accurately tracks saturation to levels as low as 60%, which will greatly assist caregivers in the management of this patient population." Severe Methemoglobinemia Detected by Pulse CO-Oximetry in the Operating Room4, a case report by Dr. Steven J. Barker and Dr. E. H. Annabi at the University of Arizona in Tucson, Arizona, documented the use of Masimo noninvasive methemoglobin (SpMet®) to accurately diagnose a severe case of drug-induced methemoglobinemia and subsequently monitor and guide the patient's treatment and recovery. Researchers concluded that Masimo SpMet can "quickly diagnose" methemoglobinemia in the perioperative setting, where time is of the utmost essence. Commercial Exhibit Highlights Masimo also previewed, for the first time, continuous noninvasive total hemoglobin (SpHb) and oxygen content (SpOC) as part of the Rainbow SET platform during WCA's commercial exhibition. In the first five hours alone, an astounding number of over 1,000 anesthesiologists visited the booth and experienced first-hand product demonstrations and clinical presentations of the new SpHb and SpOC parameters, along with Masimo's measure-through motion and low perfusion pulse oximeters. Scores of anesthesiologists who perform invasive hemoglobin testing routinely during surgery were amazed by the ability to get their own hemoglobin levels tested noninvasively in just seconds. In fact, anesthesiologists were heard proclaiming "this changes everything" and "noninvasive hemoglobin will revolutionize anesthesiology!" "The new clinical evidence for Masimo Rainbow SET and preview of SpHb and SpOC were extremely well-received by anesthesiologists from around the world at the WCA," stated Joe E. Kiani, Founder and CEO of Masimo. "We are proud to once again revolutionize noninvasive monitoring for the benefit of patient care." Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated, "Noninvasive total hemoglobin represents an exciting and valuable expansion of the noninvasive hemodynamic capabilities available to anesthesiologists. Many of whom remarked that the ability to see total hemoglobin and oxygen content measurements, along with carboxyhemoglobin (SpCO®), methemoglobin (SpMet), pleth variability index (PVI™), perfusion index (PI), oxygen saturation (SpO2) and pulse rate—all on one screen, with one device and one sensor, was equally impressive." About Masimo Forward Looking Statements 1 Continuous Noninvasive Measurement of Hemoglobin via Pulse CO-Oximetry. Mark R. Macknet, Penny L. Kimball-Jones, Richard L. Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma Linda University, Loma Linda, CA. Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, and Pulse CO-Oximeters are trademarks or registered trademarks of Masimo Corporation. |
|
Masimo Reports Fourth Quarter 2007 and Full Year 2007 Financial Results Record results mark 18 th consecutive quarter of revenue growth 2007 Highlights:
Irvine, California, February 26, 2008 – Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion & Low Perfusion pulse oximetry, today announced its financial results for both the quarter and year ended December 29, 2007. For the fiscal fourth quarter, Masimo reported product revenues of $55.2 million representing a 29% increase over $42.9 million for the fourth quarter of 2006. Including royalty revenues, Masimo reported total fourth quarter revenues of $69.3 million compared to $61.6 million for the fourth quarter of 2006. Net income for the quarter was $12.1 million representing $0.20 earnings per common share, including $0.02 per common share relating to a year-to-date tax benefit recorded in the fourth quarter. Masimo also reported that it shipped 29,400 Masimo SET and Masimo Rainbow SET oximetry units, excluding handheld units, during the fourth quarter of 2007, up 10% from 26,700 in the comparable prior year period, resulting in a new estimated worldwide installed base of 470,000 Masimo SET pulse oximeters. For the year ended December 29, 2007, Masimo's product revenues were $199.7 million, up 29% from $155.1 million in 2006. Including royalty revenues, Masimo's total revenues were $256.3 million for the year ended December 29, 2007, up from $224.3 million in 2006. In the year ended December 29, 2007, Masimo shipped 116,300 Masimo SET and Masimo Rainbow SET pulse oximeter units, excluding handheld pulse oximeters, compared to 96,600 in 2006, representing a 20% increase in new pulse oximeter and Pulse CO-Oximeter shipments. Net income for the year ended December 29, 2007, was $42.3 million compared to $181.8 million in 2006, which included $262.6 million in net patent litigation settlement proceeds and various one-time stock option based bonus payments related to a January 2006 patent litigation settlement. For the year ended December 29, 2007, Masimo's reported net income attributable to common stockholders was $23.1 million, or $0.60 per common share, as compared to $3.04 per common share for the year ended December 31, 2006. Cash, cash equivalents and short-term investments rose to $96.7 million at December 29, 2007 up from $88.6 million at September 29, 2007 and from $55.4 million at December 31, 2006. Financial Guidance For the full year 2008, Masimo expects total revenues to be approximately $292 million and total product revenues to be approximately $246 million. Masimo also expects full year 2008 earnings per common share to be approximately $0.52 per share. Included in the $0.52 per common share projection is approximately $11.0 million in expected 2008 non cash stock based compensation charges, up from $3.9 million in 2007. Stock based compensation charges are expected to increase due principally to the increase in the market price of our common stock and to due to the increase in the number of options granted consistent with the increase in our total employee headcount. The projections and guidance set forth above are estimates only and actual performance could differ. Conference Call Masimo will hold a conference call today at 2:00 p.m. PT (5:00 p.m. ET) to discuss the results. The dial-in numbers are (800) 295-4740 for domestic callers and (617) 614-3925 for international callers. The reservation number for both dial-in numbers is 39491099. 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 March 26, 2008. In addition, a telephonic replay of the call will be available until March 10, 2008. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. Please use reservation code 89834871. The financials results included in this release are unaudited. The complete audited financial statements of the company for the year ended December 29, 2007 will be included in the Masimo Annual Report on Form 10-K, to be filed with the SEC early next month. About Masimo Forward-Looking Statements Masimo Corporation Media Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpCO, SpMet, PVI and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
|
|
Masimo Announces Continuous Noninvasive Total Hemoglobin Masimo to debut this latest Rainbow SET® parameter at the upcoming World Congress of Anesthesiologists Meeting Irvine, California - February 25, 2008 - Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced that it will debut its breakthrough technology for noninvasive and continuous total hemoglobin (SpHb™) and oxygen content (SpOC™) monitoring at the World Congress of Anesthesiology (WCA) in Cape Town, South Africa, on March 3, 2008. The advent of noninvasive total hemoglobin within the Masimo Rainbow SET platform will make hemoglobin testing more convenient and broadly available to medical personnel in both the acute and outpatient settings—the measurement is instantaneous and pain-free. Over 350 million hemoglobin tests are done in the US alone each year. Prior to Masimo Rainbow SET, invasive and time-consuming lab tests were the only methods available to determine total hemoglobin levels which provided delayed and intermittent data. Masimo expects to make SpHb and SpOC shipments to select customers for clinical use in the second half of 2008, pending regulatory clearances. There is a 510(k) pending for SpHb and SpOC in the US. Martin Allard, M.B.Ch.B, FRC, Professor and Director of Research, Department of Anesthesiology, Loma Linda University, stated, "From its application as a noninvasive tool for universal hemoglobin screening at routine health check-ups to the management of blood loss and blood replacement in patients experiencing acute blood loss, or those undergoing surgery—these new measurements could prove to be indispensable in a wide variety of healthcare settings." "Noninvasive, continuous total hemoglobin and oxygen content monitoring should allow for more timely interventions both inside and outside of the operating room and should enable emergency medical professionals, dialysis centers, family physicians, cardiologists and other care providers to better care for their patients," said Joe E. Kiani, Founder & CEO of Masimo. For the first time, the Masimo Rainbow SET technology platform will provide clinicians with access to real-time trending and tracking of a patient's total hemoglobin status enabling them to quickly identify conditions of anemia, or blood loss. When patients undergo blood transfusions, clinicians will be able to use Masimo Rainbow SET SpHb to titrate blood and maintain hemoglobin levels within acceptable ranges. Additionally, continuous monitoring of hemoglobin levels may provide clinicians with an early warning of possible internal hemorrhaging in the emergency department, trauma and post-op settings. Because blood and hemoglobin restoration must be carefully titrated to targeted levels to avoid potentially serious morbidities, Masimo Rainbow SET SpHb provides instant feedback that the proper levels are achieved, advancing patient safety and accelerating recovery. On July 30, 2007, The Centers for Medicare and Medicaid Services released their final National Coverage Determination (NCD) restricting coverage for the treatment of anemia, specifically Erythropoiesis Stimulating Agents (ESA) therapy, to when the hemoglobin level is less than 10g/dL. This ruling makes hemoglobin testing a prerequisite to coverage and possibly administration of ESA therapy in certain patients. "I believe the availability of Masimo Rainbow SET SpHb will revolutionize the management of anemia across clinical settings and scenarios and could provide a solution for those looking to satisfy The Centers for Medicare and Medicaid Services' new rules for hemoglobin testing," stated Michael O'Reilly, MD, EVP of Medical Affairs at Masimo. About Masimo Forward Looking Statements Contact: Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, and Pulse CO-Oximeters are trademarks or registered trademarks of Masimo Corporation. |