This has been an exciting and successful year for all of us here at Masimo, and we wish to share our success with charitable organizations that you choose by making a donation to them on your behalf.
This year was particularly noteworthy for us at Masimo as it marks several key milestones, not the least of which is the shipment of our 500,000th oximeter-a Masimo Radical 7® with Masimo Rainbow SET® technology. We continued our commitment to provide clinicians with the tools they need to improve patient safety and enhance patient care with the introduction of several new products and measurements in 2007. We expanded the capabilities of our Masimo Rainbow SET technology platform with the addition of continuous and noninvasive methemoglobin (SpMet™) measurements and Pleth Variability Index (PVI™), with potential clinical applications for the noninvasive detection of hypovolemia and fluid responsiveness monitoring. In addition, we launched Masimo Patient SafetyNet™, a remote monitoring and clinician notification system to help keep patients safe on general wards that has already demonstrated its value in real-world clinical settings.
As exciting as this year has been, though, it could not have been accomplished without your efforts and support. It is your unwavering commitment to quality that energizes us, your passion for improving care that drives us, and your heroic efforts to advance patient safety that validates us.
As a show of gratitude and with a heart-felt desire to give something back to a few of the organizations that share in our global pursuit for better care and a better world, Masimo would like to donate $10 to the charity of your choice. We will make this donation in the name of each person who is an official member of Livewire as of today and who responds to this Livewire with their charity choice from the list below:
Amnesty International
Opportunity International
CARE
Swan Foundation in Medical Ethics
Doctors Without Borders
UNICEF
Huntington's DSA
United Way
Make-a-Wish Foundation
World Vision
March of Dimes
911 Research
Please send us an e-mail specifying your selection to: charity@masimo.com. Only requests by e-mail to this address will be processed. We also encourage you to include any comments or suggestions you might have that will help us to better fulfill our mission and adhere to our guiding principles.
Masimo's Mission
Improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications.
Masimo's Guiding Principles
Remain faithful to your promises and responsibilities.
Thrive on fascination and accomplishment and not on greed and power.
Make each day as fun as possible.
Strive to make each year better than the year before, both personally and for the Team.
Do what is best for patient care.
Thank You!
Masimo Chairman and CEO Joe E. Kiani holds the 500,000th Masimo pulse oximeter.
Alta Bates Summit Medical Center receives shipment milestone-expanding their depth and breadth of Masimo SET and Masimo Rainbow SET technologies
Irvine, California - December 21, 2007 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, today announced that it has just shipped its 500,000th Masimo SET bedside pulse oximeter (excluding hand-held units) to Alta Bates Summit Medical Center, a Sutter Health network affiliate in Oakland and Berkeley, California, as part of a five-year technology expansion agreement. Following the conversion to Masimo SET pulse oximetry more than three years ago, Alta Bates Summit Medical Center recently decided to expand the relationship by adding more equipment and entering into a facility-wide site license for Masimo Rainbow SET parameters. Also this year, Sutter Health established Masimo SET as its system-wide standard for pulse oximetry.
Achieving 500,000 shipments highlights an increasing momentum in the clinical adoption of Masimo SET as the "gold standard" in pulse oximetry. Masimo's 200,000th shipment came in 2004, the eighth anniversary of Masimo SET shipments. The 500,000th shipment was achieved less than four years later. The growth comes as leading hospitals and health networks, like Alta Bates Summit Medical Center and Sutter Health, have recognized the superior performance of Masimo SET pulse oximetry and the clinical importance of the new, upgradeable Masimo Rainbow SET technology platform as key building blocks in helping them improve patient care and enhance patient safety initiatives.
Today, many of the world's leading hospitals have converted to Masimo SET technology, including four of the top five as listed on the US News & World Report Honor Roll, and over 50 monitoring brands have integrated Masimo SET technology into their multiparameter monitor solutions.
Nancy E. Brosnan, R.N. CCRN, Critical Care Nurse Manager, Alta Bates Summit Medical Center said, "We made the decision to move to Masimo SET pulse oximetry more than three years ago because, quite simply, the Masimo technology was a better than what was available at the time-and it has proven to be a very good product. The new capabilities of the Masimo Rainbow SET platform will provide our clinicians with a powerful new set of noninvasive measurements that will enable us to more effectively assess the cardiopulmonary status of our patients on a continuous basis, facilitating more expeditious treatment decisions that are inherently important to enhancing patient safety and improving outcomes. We couldn't afford to ignore this opportunity."
Alta Bates Summit Medical Center, a 1,094-bed not-for-profit medical center with over 218,000 outpatient visits and more than 79,000 emergency department visits annually, is a HealthGrades 2007 Distinguished Hospital Award Winner for Clinical Excellence-ranking among the top 5% in the nation for overall clinical excellence. Sutter Health is one of the nation's leading not-for-profit networks of community-based health care providers, delivering high-quality care in more than 100 Northern California communities. It is also the regional leader in infant deliveries, neonatology, orthopedics, pediatrics and cancer care services. Sutter Health supports more than 26 not-for-profit hospitals, as well as physician organizations; medical research facilities; a region-wide home health, hospice and occupational health network; and long-term care centers. A patient safety pioneer, Sutter Health network is raising the bar on patient safety with a $1.2 billion network investment in a broad range of patient safety initiatives over the next 10 years.
"Masimo SET is the right choice for our system-wide standard for pulse oximetry," said Ian Leverton, M.D., Vice President, Sutter Health Clinical Integration. "Masimo is an industry leader at the forefront of technology with superior clinical performance, and it was available at a significant financial savings."
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 rendered conventional pulse oximetry virtually useless.
Since then, Masimo SET Read-Through Motion and Low Perfusion pulse oximetry has become the new performance standard for leading hospitals like Alta Bates and now Sutter Health-making continuous, noninvasive monitoring by pulse oximetry more reliable and clinically-relevant than ever before. As a result, the industry has not only come to depend on continuous noninvasive physiologic monitoring by Masimo SET pulse oximetry, but industry-leading associations-like The Joint Commission (JCAHO), American Society of Anesthesiologists (ASA), and the Institute for Healthcare Improvement (IHI)-are now establishing industry standards for patient safety on general care floors based on continuous pulse oximetry monitoring in combination with appropriate clinician alerts and notification when physiologic conditions change.
Today, Masimo Rainbow SET, an upgradeable noninvasive technology platform featuring the accuracy and reliability of Masimo SET Read-Through Motion and Low Perfusion pulse oximetry, is revolutionizing patient monitoring by significantly expanding the ability to capture, track and monitor additional blood constituents that previously required invasive procedures. The first and only technology platform capable of continuously and noninvasively measuring carboxyhemoglobin (SpCO™),methemoglobin (SpMet™) and, pleth variability index (PVI), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate, Masimo Rainbow SET is helping to advance patient safety and improve care.
According to Charles Van Doren, Chief of Clinical Engineering at Alta Bates Summit Medical Center, "When we first began to implement the Masimo product into our facilities over three years ago in order to standardize pulse-ox sensors, we found we were going from sensor standardization to improving our patient care. At the same time we were replacing our physiological monitors in our ICU's at the Summit campus we upgraded to Masimo. Working together with the Nurse Managers, Material Management, Clinical Engineering and Masimo Sales, we are now using only Masimo Technology throughout the medical center. The new Rainbow SET technology platform will allow us to grow as new technology becomes available."
Joe E. Kiani, Chairman and CEO of Masimo, stated "It is gratifying to see how Masimo SET and Masimo Rainbow SET technologies are transforming the clinical value and relevance of pulse oximetry by providing clinicians with a solution they can depend on and grow with. Our 500,000th shipment is a milestone that reflects the choices of the health care community-from clinicians who demand it and patient monitoring providers who work to integrate it, to hospitals and health networks, like Alta Bates Summit Medical Center and Sutter Health, that standardize on it-Masimo technologies are improving and saving lives. Alta Bates Summit Medical Center and Sutter Health are exceptional medical organizations that set their sights high on patient safety and we are proud to celebrate and share this milestone shipment with them."
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide 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 carboxyhemoglobin (SpCO) and methemoglobin (SpMet), 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.
Contact: Tom McCall Masimo Corporation 949-297-7075
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 and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo to Present at 26th Annual JPMorgan Healthcare Conference
IRVINE, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Masimo Corporation (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced today that it is scheduled to present at the 26th Annual JPMorgan Healthcare Conference at The Westin St. Francis in San Francisco, CA on Monday, January 7, 2008 at 8:30 a.m. PT. Joe E. Kiani, Chairman and CEO, and Mark P. de Raad, Executive Vice President and CFO, will be presenting.
A live Web cast of the presentation will be available on the Masimo Web site at http://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 Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.
SOURCE Masimo Corporation
CONTACT: investors, Mark P. de Raad, Executive Vice President and Chief Financial Officer, +1-949-297-7080, mderaad@masimo.com, or media, Tom McCall, Vice President, Corporate Communications, +1-949-297-7075, all of Masimo Corporation
Nationwide Respiratory Signs Preferred Pulse Oximetry Agreement with Masimo
Survey indicates most Nationwide members believed false alarms from patient motion were a significant distraction to care, emphasizing the need for more advanced pulse oximetry technology
Irvine, California - December 13, 2007 - Nationwide Respiratory and Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced that they have entered into a preferred provider agreement making Masimo SET pulse oximetry technology available to Nationwide's network of over 150 independent respiratory homecare providers. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide the most trustworthy SpO2 and pulse rate measurements even under the most difficult clinical conditions, including patient motion and low peripheral perfusion.
Nationwide Respiratory, part of the VGM Group-the nation's largest member service organization for Home Medical Equipment (HME)-is a national network of over 150 independent respiratory homecare providers in the U.S. with more than 400 locations. These homecare providers use the pulse oximeter to assess the oxygen saturation of a patient during overnight sleep tests in order to determine whether or not the patient meets established Medicare or private insurance guidelines for home oxygen therapy.
Tom Pontzius, President, Nationwide Respiratory, stated "The ability to detect and capture true hypoxic events, in real-time, are essential in the administration of overnight oxygen saturation sleep tests; however, inaccurate readings and false data due to motion have hindered the effectiveness of these tests for our members. The accuracy and reliability of the pulse oximeter, even through patient motion, is crucial to effectively qualifying a patient for home oxygen therapy. Medicare guidelines cover home oxygen therapy if a patient's SpO2 drops below 89% for at least 5 minutes with a mean of 85% or less in an overnight sleep test. Getting this data correct is absolutely vital to ensuring a patient receives adequate respiratory homecare. Based on third party clinical literature and our surveys, we concluded that Masimo is by far the best choice for detecting hypoxemias and hypopneas and reducing false alarms."
Joe E. Kiani, Chairman and CEO of Masimo, said "Nationwide Respiratory is one of the nation's leading independent home respiratory provider networks. Dedicated to providing selection, service and support during the entire sleep apnea diagnosis and treatment process, Nationwide Respiratory has taken the proactive steps necessary to help its members advance the level of care they deliver. They recognized that their members have significant challenges with their current pulse oximetry solutions and were willing to invest in advanced technology, like Masimo SET, to resolve them. We are excited to partner with Nationwide Respiratory and look forward to meeting the pulse oximetry needs of their members."
As part of the contracting process, Nationwide Respiratory surveyed all its members to better understand their needs in the care of their patients with pulse oximetry. The results revealed the need for more advanced pulse oximetry technology as members overwhelmingly cited reduction in false alarms and more accurate/reliable data as reasons for their need to switch to a better pulse oximetry technology.
Reduction in False Alarms The majority of members surveyed said that SpO2 false alarms due to patient motion are the most common type of alarms, generating the greatest number of phone calls from patients in the home. As a result, most Nationwide members surveyed said they would invest in technology if it could reduce false alarms due to motion.
Masimo SET is a breakthrough Read-Through Motion and Low Perfusion pulse oximetry technology that uses advanced breakthrough signal processing algorithms to deliver accurate and reliable SpO2 and pulse rate measurements. 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.
More Accurate and Reliable Oxygen Saturation Data Nationwide Respiratory members also confirmed that as many as 40% of overnight oximetry tests do not capture enough "real" hypoxic events and most survey respondents said they would invest in a more powerful oximetry technology if it was proven to capture more 'real' hypoxic events and improve the effectiveness of their overnight oximetry program.
Unlike conventional pulse oximeters, Masimo SET provides the greatest sensitivity (ability to detect true positives), at 98%, with the greatest specificity (the ability to reject false positives), at 97%, based on independent and objective evaluations and studies that have examined oximeter performance in real clinical environments. In fact, in a pediatric sleep laboratory setting, Masimo SET technology was found to accurately detect hypopneas 98.6% of the time, while Nellcor detected only 45.3%-missing greater than 50% of pediatric hypopneas.1
"As a result of this survey, we heard our members loud and clear and have chosen to partner with Masimo because they are the leader in oximetry technology," said Tom Pontzius, President Nationwide Respiratory.
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide 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 carboxyhemoglobin (SpCO) and methemoglobin (SpMet), 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.
1 Differences in Pulse Oximetry Technology can Affect Detection of Sleep-Disordered Breathing in Children. Robert Brouillette, Jacinthe Lavergne, Andra Leimanis, Gillian Nixon, Sylvia Ladan, Christine McGregor. Department of Pediatrics, Montreal Children's Hospital, McGill University, Montreal, Quebec, Canada.
Contact: Tom McCall Masimo Corporation 949-297-7075
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 and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Breaking Studies at AARC Congress Show Masimo SET and Masimo Rainbow SET to be Accurate, Effective and Uniquely Beneficial in Detecting and Tracking Disease States
Orlando, Florida -- December 3, 2007 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that multiple independent and objective clinical studies and case studies presented this week at the 2007 American Association of Respiratory Care (AARC) Annual Congress in Orlando, Florida, focused on the unique capabilities of Masimo's noninvasive patient monitoring technologies in the diagnosis, treatment and recovery of several disease states, including pulmonary effusion, methemoglobinemia, carboxyhemoglobin and hypoxemia-helping clinicians provide more rapid, improved patient care.
These new studies add to the more than 100 independent and objective studies demonstrating the superiority of Masimo SET pulse oximetry, as well as adding to the growing body of research proving the efficacy of Masimo Rainbow SET in providing accurate, reliable physiological measurements of multiple blood constituents that previously required invasive procedures. Built on the "gold-standard" of Masimo SET Read-Through Motion and Low Perfusion technology, Masimo Rainbow SET is the first and only upgradeable technology platform capable of continuously and noninvasively measuring carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pleth variability index (PVI), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate. Highlights of key study findings include:
New Masimo Rainbow SET SpMet Measurement Enables Rapid Diagnosis and Tracking of Benzocaine-induced Methemoglobinemia
In the case study entitled "Benzocaine Induced Methemoglobinemia After TEE," a team of Anesthesiologists headed by Dr. Mark R. Macknet at Loma Linda University in Loma Linda, California, documented the accuracy of the Masimo Rad-57 Pulse CO-Oximeter in the diagnosis and continuous monitoring of SpMet levels during a case of benzocaine-induced methemoglobinemia after transesophageal echocardiography and subsequent treatment with methylene blue. Researchers observed, 40 minutes following the benzocaine administration, a drop in the patient's oxygen saturation to 88% along with SpMet readings, as reported by the Rad-57, greater than 50%. When an arterial blood sample was analyzed by laboratory CO-Oximeter, the results reported SpMet "value over calibration limits" of the invasive laboratory CO-Oximeter. Researchers treated the patient with methylene blue using the Masimo Rad-57 Pulse CO-Oximeter "to guide the therapy" and concluded that the new Masimo Rainbow SET Pulse CO-Oximeter "has documented SpMet accuracy" enabling them to "rapidly confirm the diagnosis and continuously monitor the levels of methemoglobin."1
Masimo Rainbow SET Pulse CO-Oximetry Shown Effective in the Rapid Recognition and Continuous Measurement of Carboxyhemoglobin (SpCO)
In a report entitled "Detection of CO-Poisoning Through Pulse CO-Oximetric Measurement" by Dr. Frank Marx, Rettungsdienst, Berufsfeuerwehr Duisburg Fire Department and Emergency Service, Duisburg, Germany, the researcher used the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to quickly and accurately diagnose and triage two patients with acute CO-poisoning requiring immediate transportation to a Center of HBO (hyperbaric oxygen therapy) for treatment. Both patients had SpCO values greater than 20%, yet recovered completely following the success of immediate HBO treatment. The results of these case reports illustrate that suspected CO-poisoning "can be proven with the Masimo Rad-57 Pulse CO-Oximeter" enabling responsive "triage decisions in the field so that special treatment in an HBO facility can be arranged." Additionally, researchers concluded, "the Rad-57 Pulse CO-Oximeter provides rapid noninvasive assessment of victims and provides information that directly impacts triage and treatment decisions at the emergency scene."2
In another study entitled "Carboxyhemoglobin Levels in Smokers vs. Non-Smokers in a Smoking Environment," researchers from Ozarks Technical Community College in Springfield, Ohio, headed by Aaron Light, used the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to observe how non-smokers exposed to cigarette smoke are affected by CO-poisoning. Aided by SpCO measurements obtained from the Masimo Rad-57 Pulse CO-Oximeter, researchers tested 33 smokers (avg. SpCO of 5.04%) and 27 non-smokers (avg. SpCO of 2.49%) in an establishment where cigarette smoke was very noticeable against a control group of 50 non-smokers (avg. SpCO of 1%) in a well-ventilated non-smoking environment and found that the average SpCO level for the non-smokers in a smoking environment was nearly two and one half times higher than the control group indicating that "non-smokers are not exempt from the effects of cigarette smoke in the atmosphere."3
New Masimo Rainbow SET PVI Measurement May Provide Significant Value in the Detection and Treatment of Processes that Produce Increased Intrathoracic Pressure
In a study entitled "The Use of Pleth Variability Index (PVI) to Detect Changes in Intrathoracic Pressure," a team of Neonatologists headed by Dr. Mitchell Goldstein at the Loma Linda University Children's Hospital in Loma Linda, California, observed the correlation between Masimo PVI during pre-tap and post-tap epochs in a 6-week-old newborn with pulmonary effusion and found that PVI was significantly increased post-drainage. Study findings showed that PVI consistently increased-from 17.6 pre-tap to 21.8 post-tap in the first tap, 25.2 to 33.8 in the second, 17.6 to 20.0 in the third and 19.9 to 25.1 in the fourth-indicating that "an increase in the PVI dynamic could be correlated to the release of intrathoracic pressure." Researchers concluded, "PVI may have significant value in the diagnosis and treatment of processes that produce increased intrathoracic pressure, such as pneumothorax, chylothorax, and in this case pulmonary effusion."4
Masimo SET Read-Through Motion and Low Perfusion Pulse Oximetry More Reliable and Accurate During Air Transport
In a separate study entitled "Rad-5 and MRL SpO2 Comparison Trial: A Prospective Analysis of Pulse Oximetry During Air Transport," Jason A. Elliott of REACH, Mediplane Inc., in Santa Rosa, California, conducted a three-month prospective review of the Masimo SET Read-Through Motion and Low Perfusion Rad-5 pulse oximeter and the Welch Allyn MRL with Nellcor pulse oximetry on a total of 158 helicopter air ambulance missions and found that the Masimo Rad-5 provided more reliable and accurate SpO2 measurements during air transport and detected more real hypoxic events than the Nellcor pulse oximeter. Researchers concluded that the Nellcor pulse oximeter inside the Welch Allyn MRL had "more than two-fold increase in failure rate over the Masimo Rad-5 pulse oximeter."5
Other studies presented at AARC showed promising results for Masimo engineering prototype technologies, the Acoustic Respiration Monitoring technology (ARM) and noninvasive and continuous hemoglobin measurement (SpHb).6,7
Joe E. Kiani, Chairman and CEO of Masimo, stated, "These studies not only showcase the ability of Masimo Rainbow SET to rapidly and accurately diagnose a disease state, but to also track the progression of and recovery from that state-enabling critical real-time assessments that show whether a patient is improving or declining with intervention. This tracking and trending capability provides clinicians with the useful clinical data they need to ensure prompt administration of the most appropriate life-saving treatment. We are happy that the technologies we have developed are helping clinicians improve patient care and safety."
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide 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 carboxyhemoglobin (SpCO) and methemoglobin (SpMet), 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.
1 Benzocaine Induced Methemoglobinemia After TEE. Mark R. Macknet, Penny L. Kimball-Jones, Richard L. Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma Linda University, Loma Linda, CA. 2 Detection of CO-Poisoning Through Pulse CO-Oximetric Measurement. Frank Marx. Rettungsdienst, Berufsfeuerwehr, Duisburg, Germany. 3 Carboxyhemoglobin Levels in Smokers vs. Non-Smokers in a Smoking Environment. Aaron Light, Casie Grass, Doug Pursley, Julie Krause. Ozarks Technical Community College, Springfield, MO. 4 The Use of Pleth Variability Index (PVI) to Detect Changes in Intrathoracic Pressure. Mithcell Goldstein, Merrick Lopez, Daniel Saesim, Richard Peverini. Neonatology, Loma Linda University Children's Hospital, Loma Linda, CA. 5Rad-5 and MRL SpO2 Comparison Trial: A Perspective Analysis of Pulse Oximetry During Air Transport. Jason A. Elliot. REACH, Santa Rosa, CA. 6 Accuracy of a Novel Bioacoustic Sensor in Postoperative Patients. Mark R. Macknet, Penny L. Kimball-Jones, Richard L. Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma Linda University, Loma Linda, CA. 7 Continuous Noninvasive Measurement of Hemoglobin Via Pulse CO-Oximetry During Major Surgery. Mark R. Macknet, Penny L. Kimball-Jones, Richard L. Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma Linda University, Loma Linda, CA.
Contact: Tom McCall Masimo Corporation 949-297-7075
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, SpHb, ARM, and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo Corporation Given Approval to Market the Masimo Rad-57 Pulse CO-Oximeter in Japan
Masimo receives approval from Ministry of Health, Labor and Welfare (MHLW) for the revolutionary medical device that noninvasively measures carbon monoxide levels in the blood
Irvine, California - November 27, 2007 - Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, today announced approval of the Masimo Rad-57 Pulse CO-Oximeter, bringing the world's first and only technology capable of noninvasively measuring carbon monoxide (CO) levels in the blood to the Japanese market-with 9,026 hospitals and Fire and Disaster Management Agency facilities1 and a population of more than 127 million.2
The Masimo Rad-57 is a fast, accurate and noninvasive way to detect elevated levels of CO in the blood, without having to draw blood and wait for costly lab results. When a clinician places the Masimo Rad-57's sensor on a patient's finger and presses a button, the device will detect the percentage of CO in the bloodstream in just seconds, allowing for prompt and possibly life-saving treatment. In addition, the Masimo Rad-57 measures SpO2 (oxygen saturation), pulse rate and perfusion index (PI) with Masimo SET technology.
Each year in Japan, it is estimated that about 2,000 people die from CO poisoning.3 An odorless and colorless toxic gas, poisoning from CO is notoriously difficult to diagnose because its symptoms mirror those of lesser afflictions, like the flu or food poisoning. Because of this, even the most skilled clinicians miss the chance to treat carbon monoxide poisoning early. As a result, unrecognized CO-poisoned patients are often unknowingly returned to the site of the exposure where they develop more serious levels of toxicity. Just one serious exposure to CO, as well as prolonged exposure to low levels of CO, can cause death or permanent brain, heart, or organ damage.4,5 Certain home CO detectors don't alarm when low levels of CO are present.
Prior to the Masimo Rad-57, the only method to accurately diagnose CO poisoning required inconvenient blood tests using expensive blood gas machines that are not available outside the hospital environment, where detection is often needed most. The ability to quickly and conveniently obtain accurate measurements in any environment leads to informed and timely treatment decisions, which can save lives and money.
"Having a noninvasive hand-held device that quickly measures the amount of CO in a person's blood would enable greater cost and care efficiencies at the scene of emergencies," said Yasuhiro Yamamoto M.D., Ph. D., Professor and Chairman, Department of Emergency and Critical Care Medicine, Nippon Medical School. "The ability to accurately diagnose and triage CO-poisoned victims at the scene can speed transport and proper treatment for higher priority cases, while reducing the flood of non-emergent patients at hospitals due to suspected poisonings and eliminating unnecessary lab tests."
Joe E. Kiani, Chairman and CEO of Masimo stated, "We are excited to bring the Masimo Rad-57 Pulse CO-Oximeter to the market in Japan where thousands of people die each year as a result of CO-poisoning and countless others suffer permanent brain, heart and organ damage. All too often CO-poisoning goes undiagnosed, silently robbing unsuspecting victims of precious health and life. The Masimo Rad-57 Pulse CO-Oximeter provides an easy and timely way to detect this deadly poison."
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide 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 carboxyhemoglobin (SpCO) and methemoglobin (SpMet), 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 relative to our estimation of the size of the Japanese market for the Rad-57 and the pace of clinical adoption of this new technology in Japan, as well as other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended September 29, 2007, filed with the Securities and Exchange Commission on November 1, 2007. 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 September 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
Contact: Tom McCall Masimo Corporation 949-297-7075
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 and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo Corporation Receives a Frost & Sullivan 2007 Industry Best Practices Award for Pulse Oximetry Leadership
Frost & Sullivan's industry research concludes, "Masimo pulse oximetry is the only vital sign module clinicians ask for by brand"
Irvine, California - November 20, 2007 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced it has received a Frost & Sullivan 2007 Industry Best Practices Award, for Pulse Oximetry Leadership - "ranking number one in the pulse oximetry industry." Frost & Sullivan further recognized "the impressive progression of Signal Extraction Technology (Masimo SET) to the 'gold standard' for reliable pulse oximetry monitoring" in honoring the company.
Superior Technology Historically, the performance of conventional pulse oximetry, as well as its usefulness in a variety of clinical settings, has been plagued by interfering noise due to patient motion and low peripheral perfusion, which often results in false SpO2 readings and frequent alarms. "Masimo Signal Extraction Technology (SET) eliminates the issues caused by motion artifact and low peripheral perfusion through proprietary signal processing algorithms and sensor technologies," said Frost & Sullivan analyst Mike Arani in his report.
Clinical Preference Leading clinicians around the world have put the efficacy and reliability of Masimo SET to the test in more than 100 independent and objective peer-reviewed studies that prove Masimo's revolutionary Signal Extraction Technology outperforms all others, even under the most demanding of clinical conditions. "These clinical trials have not only proved the performance superiority of Masimo SET, but time after time, they have also left a lasting impression on the participating clinicians," the report said.
Brand Recognition Also, according to the Frost & Sullivan report, "Masimo's strong brand recognition has even driven major patient monitoring companies with in-house proprietary SpO2 technologies to offer their multiparameter monitors with the choice of Masimo SET SpO2 module." Today, Masimo SET technology is widely integrated into more than 100 multiparameter monitors and over 40 monitoring brands. "After all, performance superiority is the chief reason Masimo pulse oximetry is the only vital sign module clinicians ask for by brand when purchasing a patient-monitoring product," they added.
Market Achievements Masimo's rapid market acceptance and market share gains were cited by Frost & Sullivan as visible examples of this combination of superior technology, clinical preference, brand recognition and exceptional brand development success.
In selecting Masimo for the 2007 pulse oximetry brand development strategy leadership award, Frost & Sullivan's analyst team tracked all the major participants in the pulse oximetry industry. The process included in-depth interviews with all market participants, customers and suppliers, along with extensive secondary and technology research to identify best practices within the industry. To determine the final ranking of competitors, Frost & Sullivan measured each on the basis of: development of unique brand strategies, competitor recognition and brand value, participation in industry trade groups, establishment of programs that allow the brand's customers to grow, and increases in customer loyalty. As a result of this ranking, Masimo topped the list of industry competitors.
According to Frost & Sullivan manager Antonio Garcia, "The key to Masimo's strong image lies in its vision of giving caregivers more options and capabilities than they expect. After all, Masimo simply takes the guess work out of pulse oximetry, so clinicians never have to guess what brand is the most reliable."
Joe E. Kiani, Chairman and CEO of Masimo, said "We are honored to receive this award from Frost & Sullivan. This recognition is especially meaningful because Frost & Sullivan has surveyed the market and responded with research findings that validate what we have heard clinicians saying all along and what our increasing marketshare momentum is a testament to-that clinicians recognize Masimo SET is the best pulse oximetry technology for their patients."
About Frost & Sullivan Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services, and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies and the investment community by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit http://www.frost.com.
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.
Contact: Tom McCall Masimo Corporation 949-297-7075
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad-57, APOD, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpCO, SpMet, and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo to Present at Piper Jaffray 19th Annual Healthcare Conference
Irvine, California, November 15, 2007 - Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced today that it is scheduled to present at the Piper Jaffray 19th Annual Healthcare Conference at The Pierre Hotel in New York, NY on Tuesday, November 27, 2007 at 8:30 a.m. ET. Joe Kiani, Chairman and CEO and Mark de Raad, Executive Vice President and CFO 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 approximately one hour 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 Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.
Investors Contact: Mark de Raad Executive Vice President and Chief Financial Officer (949) 297-7041 mderaad@masimo.com
Media Contact: Tom McCall Vice President, Corporate Communications Masimo Corporation 949-297-7075
New Research Shows Masimo Perfusion Index (PI) Effective in the Noninvasive Detection of Congenital Heart Defects (CHD) in Newborns
Findings show detection rate for CHD improved from 78% to 100% with Masimo's PI measurement
Irvine, California, November 14, 2007 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that a new independent and objective clinical study demonstrates the ability of Masimo SET Perfusion Index (PI) to improve detection of congenital heart defects (CHD) in newborns with duct-dependent systemic circulation. Even when routine neonatal physical examinations and saturation screenings fail, PI may help to accurately detect CHD-enabling life-saving early detection and critical intervention before discharge from the hospital. It has been documented that up to 30% of all deaths from CHD in the first year of life are due to unrecognized cases being discharged to the home.
PI is a measurement featured in the Masimo Rainbow SET technology platform that reflects the real-time changes in peripheral blood flow at the monitored site and the strength of the plethysmographic signal displayed on the pulse oximeter. In addition to improving the detection of CHD in infants, the ability to noninvasively and continuously measure PI could enable faster identification of clinically significant changes in a patient's physiologic status, including potentially hypothermia, hypovolemia, shock and/or sepsis.
In the study, entitled "Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction," conducted at the Institute of Clinical Sciences, Gothenburg University, Sweden, A de-Wahl Granelli and I Ostman-Smith observed whether PI was a dependable indicator in critically-ill newborns to enable its use for congenital heart disease screening purposes. The researchers indicated that several studies have reported that babies with congenital heart disease are not detected by routine neonatal physical examinations and that neonatal screening fails mainly in children with duct-dependent systemic circulation.
Granelli and Ostman-Smith conducted single pre- and postductal measurements of PI using the Masimo Radical SET Pulse Oximeter in a total of 10,000 healthy newborns (ranging in age from 1 hour to five days) and established PI reference values of healthy babies. In establishing reference values that validate possible PI indices for normal vs. disease state in newborns, researchers were able to show that low PI values may correspond to illness.
Study results showed that combined neonatal examination and oxygen saturation screening detected only 78% of the newborns with LHOD, but when PI was added, 100% of all newborns with LHOD showed abnormalities-indicating that PI may reflect abnormal blood flow from the heart in CHD newborns. All LHOD newborns had either pre- or postductal PI values below the interquartile cut-off value of 1.18 and five had values below a potential cut-off of 0.70, leading researchers to conclude that "PI values lower than 0.70 may indicate illness and a value less than 0.50 indicates definite underperfusion." Study findings suggest that a combination of saturation screening cut-offs with PI value cut-offs may help improve the early detection of congenital heart defects that have duct-dependent systemic circulation. As a result, researchers concluded that PI is a "promising tool for improving the detection of critical congenital heart disease with duct-dependent systemic circulation."1
Joe E. Kiani, Chairman and CEO of Masimo stated, "When we introduced Masimo SET ten years ago, we knew that the improved accuracy and fidelity would allow clinicians to more tightly control the arterial oxygen levels of their patients, but it is truly remarkable to see research like this where our technology is being used to improve screening for congenital heart defects. We are all indebted to clinicians like these from Gothenburg University who are constantly looking for ways to utilize the latest technological advancements to deliver better care."
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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 results of the PI study will be duplicated in future clinical studies and risks related to our assumptions regarding the correlation between PI and abnormal blood flow from the heart in CHD newborns, as well as changes in a patient's physiologic status, and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended September 29, 2007, filed with the Securities and Exchange Commission on November 1, 2007. 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 September 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
1 Granelli A, Ostman-Smith I. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatrica 2007;96:1455-1459.
Contact: Tom McCall Masimo Corporation 949-297-7075
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad-57, APOD, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpCO, SpMet, and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Masimo Corporation Adopts Stockholder Rights Plan
Irvine, California, November 9, 2007-Masimo (NASDAQ: MASI) the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced today that the Pricing Committee of its Board of Directors has formally adopted a stockholder rights plan.
"This plan is designed to enhance the Board's ability to protect stockholders against unsolicited attempts to acquire control of the company that do not offer an adequate price to all stockholders or are otherwise not in the best interests of the company and its stockholders and customers," said Joe E. Kiani, Chairman and CEO of Masimo. "The plan is intended to provide the Board with sufficient time to consider any and all alternatives to such an action."
As disclosed in the Company's previous filings with the Securities and Exchange Commission in connection with its initial public offering, the Company anticipated adopting a stockholder rights plan following the completion of its IPO, which occurred on August 13, 2007. The Plan was not adopted in response to any attempt to acquire the Company. Under the Plan, each common stockholder of the Company at the close of business on November 26, 2007 will receive a dividend of one right for each share of the Company's common stock held of record on that date. Each right will entitle the holder to purchase from the Company, in certain circumstances described below, one one-thousandth of a share of newly-created Series A junior participating preferred stock of the Company for an initial purchase price of $136 per share. The rights distribution will not be taxable to stockholders and the distribution of rights under the Plan will not interfere with the Company's business plans or be dilutive to or affect the Company's reported per share results.
Initially the rights will be represented by the Company's common stock certificates and will not be exercisable. The rights will generally become exercisable ten business days after any person has become the beneficial owner of 15% or more of the Company's common stock or has commenced a tender or exchange offer which, if consummated, would result in any person becoming the beneficial owner of 15% or more of the common stock of the Company.
If any person becomes the beneficial owner of 15% or more of the Company's common stock, each right will entitle the holder, other than the acquiring person, to purchase Company common stock or common stock of the acquiring person having a value of twice the exercise price. In addition, if there is a business combination between the Company and the acquiring person, or in certain other circumstances, each right that is not previously exercised will entitle the holder (other than the acquiring person) to purchase shares of common stock of the acquiring person at one-half of the market price of those shares.
The Company may redeem the rights at a price of $0.001 per right at any time prior to the date on which any person has become the beneficial owner of 15% or more of the common stock of the Company. The rights will expire on November 8, 2017, unless earlier exchanged or redeemed.
The Company will file with the Securities and Exchange Commission a Current Report on Form 8-K describing the stockholder rights plan. The Form 8-K will include a copy of the Rights Agreement governing the Plan as an exhibit.
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at www.masimo.com.
Masimo Corporation
Investors: Mark P. de Raad Executive Vice President and Chief Financial Officer (949) 297-7080 mderaad@masimo.com
Media: Tom McCall Vice President, Corporate Communications (949) 297-7075 tmccall@masimo.com
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad-57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. Rainbow, SpCO, SpMet and Pulse CO-Oximeter are trademarks of Masimo Corp.
National Association of EMS Educators (NAEMSE) Recommends Screening for Carbon Monoxide Poisoning
NAEMSE Letter to Members Warns of Critical and Fatal Implications of Missing the Diagnosis of Carbon Monoxide Poisoning
Irvine, California, November 08, 2007 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, today announced the National Association of EMS Educators (NAEMSE) has issued guidance to all its members advocating carbon monoxide screenings for patients presenting with any of the signs and symptoms of carbon monoxide poisoning or suspected exposure. In addition, the organization is advocating enhanced carbon monoxide training programs for all EMS professionals to help improve outcomes and save lives.
In a letter to its membership issued earlier this month, NAEMSE said failing to diagnose carbon monoxide (CO) poisoning during the emergency response efforts may lead to poor pre-hospital decisions, including failure to transport, failure to transport to an appropriate facility, failure to properly treat and failure of the emergency department to diagnose. The consequence of misdiagnosis can often result in returning the patient to a poisoned environment, possibly leading to a fatal outcome. Recognizing that CO poisoning-the most common form of poisoning in the United States-is notoriously difficult to detect, NAEMSE said improved screening and implementation of proper carbon monoxide EMS training programs "can no doubt lead to improved outcomes for patients and potentially save many lives."
Too often, even the most skilled first responders can miss the chance to treat carbon monoxide poisoning early because until now there hasn't been a fast, accurate and noninvasive way to detect elevated levels of CO in the blood. However, with the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter, EMS professionals can easily detect carbon monoxide poisoning on the spot in just seconds with the push of a button, allowing for prompt and possibly life-saving treatment. In addition, Rad-57 can also limit the likelihood of long-term cardiac and neurological damage that can result from non-fatal exposures.
"We see first hand the overwhelming and immediate need for carbon monoxide screening during the first response stage and the importance of standardized carbon monoxide training protocols for EMS professionals as a matter of public safety," said NAEMSE President Angel Burba.
NAEMSE will soon have a new online training program available to all its members, free of charge, on their website www.naemse.org. The program-consisting of four carbon monoxide modules developed by Dr. Bryan Bledsoe and approved by top EMS physicians and professionals-covers the physiological dangers of CO poisoning, its signs and symptoms, as well as noninvasive methods for on-scene detection of CO in the blood. The modules include downloadable student workbooks, instructor manuals and PowerPoint slides for classroom presentation. Dr. Bryan Bledsoe is an emergency physician, highly regarded as one of the premier educators in the EMS field, and the leading author of numerous EMS textbooks.
Joe E. Kiani, Chairman and CEO of Masimo stated, "NAEMSE's recommendations for proper EMS training and field screening of carbon monoxide poisoning represents an important milestone in the establishment of new protocols for emergency responsiveness and improved public safety. If implemented nationwide, these recommendations will help reduce morbidity and mortality from unsuspected cases of carbon monoxide poisoning."
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.
Contact: Tom McCall Masimo Corporation 949-297-7075
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. ARM, Acoustic Respiratory Monitoring, ,Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.
Masimo Rad-57 Too often, even the most skilled first responders miss the chance to treat carbon monoxide poisoning early because until now there hasn't been a fast, accurate and noninvasive way to detect elevated levels of CO in the field. With the Masimo Rad-57 you can easily detect carbon monoxide poisoning on the spot in just seconds with the push of a button, allowing for prompt and possibly life-saving treatment.
Community Health Network of Indianapolis Completes System-Wide Conversion to Masimo SET Pulse Oximetry Technology
Irvine, California - November 1, 2007 -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, announced the completion of CHN's system-wide implementation of Masimo SET pulse oximetry. Building on a four-year history of superior Masimo SET performance in other areas of its network, CHN expanded the adoption of Masimo SET pulse oximetry technology to virtually every site - making Masimo SET CHN's standard of care for precise, continuous SpO2 monitoring.
"The decision to convert our entire network to Masimo SET technology was an easy one," said Steve Erdosy, M.D., BioMed Clinical Engineer at Community Health Network. "The superior clinical performance we experienced with Masimo SET pulse oximetry in The Indiana Heart Hospital, which converted in 2003, prompted the need to have this advanced technology available in all our sites."
Ranked among the top 20 integrated health care networks in the nation, Community Health Network has more than 70 sites of care throughout central Indiana. This includes Community Hospitals East, North and South in Indianapolis and Community Hospital Anderson; The Indiana Heart Hospital, a dedicated heart hospital; Indiana Surgery Centers; Community Physicians of Indiana; Community Home Health Services; MedCheck urgent care centers; occupational health services; nursing homes; and other health care facilities. In 2006, CHN was recognized as a Performance Improvement Leader by Thomson Healthcare and, since 2001, has had fewer adverse patient safety events and discharged patients almost a day earlier.
In reaffirming the decision to convert system-wide to Masimo SET oximetry, Jan Nellinger, New Technology Analyst at Community Health Network, cited Masimo's seamless conversion as an added benefit: "The conversion was pretty invisible internally, except that the addition of the new Masimo SET pulse oximeters was a big hit with our clinical staff."
By making the conversion to Masimo, the Community Health Network joins other 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. Masimo SET is widely recognized as the most accurate and reliable pulse oximetry technology in the world, clinically proven in more than 100 independent and objective studies to provide the most trustworthy SpO2 readings even under the most difficult clinical conditions, including patient motion and low peripheral perfusion. These studies prove Masimo SET delivers improvements in outcomes, safety and efficiency.
Community Health Network's system-wide conversion included standardizing virtually all of CHN's sites of care to Masimo SET pulse oximeters and sensors. Masimo advanced technology and sensor design increases the durability and longevity of the sensors and cables connecting the patient to the pulse oximeter. Made of a durable, non-absorbent tape material that extends the life of the sensor during single patient use, Masimo adhesive sensors have been shown to reduce sensor usage 49% to 56%1,2.
"Having an adhesive sensor with the accuracy and reliability of Masimo SET is a huge benefit that helps us to keep our patients safer with readings we can depend on, while Masimo's durability helps us to realize greater sensor efficiencies," continued Dr. Erdosy.
Joe E. Kiani, CEO of Masimo, stated "Community Health Network of Indianapolis' system-wide conversion and standardization to Masimo SET pulse oximetry is a particularly rewarding milestone that grew organically from clinical preference and adoption of Masimo SET technology within one department to virtually all departments in their network. We are proud to extend our partnership with CHN as they continue to leverage best-in-class technology to improve the quality and efficiency of healthcare in the greater Indianapolis community."
About Masimo
Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-Through Motion and Low Perfusion pulse oximetry, known as SET, and with it substantially reduced false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent clinical and laboratory studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.
1 Holmes M, Thomas A, Vogt J, Gangitano E, Stephenson C, Liberman R. Useful Life of Pulse CO-Oximeter Sensors in the NICU. Respiratory Care 1998;43(10):860 2 Erler T, Avenarius S, Wichniewski E, Schmidt K, Klaber H. Longevity of Masimo and Nellcor Pulse Oximeter Sensors in the Care of Infants. J. Perinatol., 2003;23:133-135
Contact: Tom McCall Masimo Corporation 949-297-7075
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corporation. ARM, Acoustic Respiratory Monitoring, BiFi, Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corporation.
Masimo Reports Third Quarter 2007 Financial Results
Record results mark 17th consecutive quarter of revenue growth
Third Quarter Highlights:
* Product revenues increased 29% to a record $51.1 million * Masimo SET pulse oximeter units increase 32% to a record 30,800 units
Irvine, California, October 30, 2007 - Masimo Corporation (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion & Low Perfusion pulse oximetry, today announced its financial results for the quarter ended September 29, 2007, with product revenues of $51.1 million representing a 29% increase over $39.8 million for the third quarter of 2006. Including royalty revenues, Masimo reported total third quarter revenues of $64.4 million compared to $57.6 million for the third quarter of 2006. Net income for the quarter was $10.6 million representing $0.16 GAAP or $0.18 non-GAAP earnings per common share.
Masimo also reported that it shipped a record 30,800 Masimo SET and Masimo Rainbow SET pulse oximeter units, excluding handheld pulse oximeters, during the third quarter of 2007, up 32% from 23,300 in the comparable prior year period, resulting in an estimated worldwide installed base of 448,000 Masimo SET pulse oximeters.
For the quarter ended September 29, 2007, due entirely to the impact of a $2.8 million, net of tax, decline in royalty payments as contemplated in our 2006 patent litigation settlement, GAAP net income declined from $12.3 million in the quarter ended September 30, 2006 to $10.6 million in the current quarter ended September 29, 2007. Masimo reported third quarter 2007 net income attributable to common stockholders of $6.9 million or $0.16 per common share as compared to $3.3 million or $0.16 per common share for the third quarter 2006. For the quarter ended September 29, 2007, on a non-GAAP basis and adjusting only for the assumed conversion of preferred stock into common stock in connection with the Masimo's recently completed initial public offering, net income was $0.18 per common share, as compared to $0.22 per common share in the prior year period.
Joe E. Kiani, Chairman and Chief Executive Officer of Masimo, said, "We are happy to report third quarter results that exceeded expectations. Our strong performance is a clear reflection of the fact that our innovative products and technologies are finding widespread adoption in virtually every segment of the clinical community. We will continue to build on these results by focusing our efforts on helping clinicians do what's best for patient care, providing them noninvasive patient monitoring technologies like our Masimo Rainbow SET platform that seek to 'solve the unsolvable' challenges in healthcare."
For the nine month period ended September 29, 2007, Masimo's product revenues were $144.5 million, up 29% from $112.3 million in the same prior year period. Including royalty revenues, Masimo's total revenues were $187.0 million for the nine month period ended September 29, 2007, up from $162.7 million in the same prior year period. In the nine month period ended September 29, 2007, Masimo shipped a record 87,000 Masimo SET and Masimo Rainbow SET pulse oximeter units, excluding handheld pulse oximeters, compared to 69,900 in the same prior year period.
Net income for the nine month period ended September 29, 2007 was $30.2 million compared to $170.9 million in the comparable prior year period, which included $262.6 million in net patent litigation settlement proceeds and various one-time stock based compensation charges related to dividend and bonus payments authorized in the first quarter of 2006. For the nine month period ended September 29, 2007, Masimo's reported net income attributable to common stockholders was $11.8 million, or $0.40 per common share, as compared to $2.79 per common share for the nine month period ended September 30, 2006. For the nine month period ended September 29, 2007, on a non-GAAP basis and adjusting only for the assumed conversion of preferred stock into common stock in connection with Masimo's recently completed initial public offering, Masimo's net income was $0.54 per common share, as compared to $3.12 per share in the same prior year period.
Cash, cash equivalents and short-term investments were $88.6 million at September 29, 2007.
In August 2007, Masimo completed its initial public offering of 13,704,120 million common shares, comprised of 10,416,626 shares sold on behalf of selling stockholders and 3,287,494 shares sold on behalf of the Company, inclusive of the underwriters' full exercise of its over-allotment option. The shares were sold at $17.00 per share, for total offering of $233.0 million of which the net proceeds to the Company was approximately $47.8 million.
Financial Guidance
For the full year 2007, Masimo now expects total revenues to be approximately $250 million up from $245 million and total product revenues to be approximately $197 million up from $195 million. Masimo also expects full year GAAP earnings per share to be approximately $0.50 per share up from $0.43 per share and non-GAAP earnings per share, adjusted only for the assumed conversion of preferred stock into common stock in connection with the Company's recently completed initial public offering, to be approximately $0.63 up from $0.55. 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) 659-2037 for domestic callers and (617) 614-2713 for international callers. The reservation number for both dial-in numbers is 20647778. 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 November 30, 2007. In addition, a telephonic replay of the call will be available until November 13, 2007. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. Please use reservation code 39086455.
Non-GAAP Measures
Masimo prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. In an effort to provide investors with additional information regarding the Company's results and to provide a meaningful period-over-period comparison of the Company's financial performance, the Company uses non-GAAP financial measures as defined by the Securities and Exchange Commission. The differences between the U.S. GAAP and non-GAAP financial measures are reconciled below. In presenting comparable results, the Company discloses non-GAAP financial measures when it believes such measures will be useful to investors, analysts and other interested parties in evaluating the Company's underlying business performance on a comparable basis with past and future reported earnings per share and with the financial guidance provided in this release. Management uses the non-GAAP financial measures to evaluate the Company's financial performance against internal budgets and targets. Importantly, the Company believes non-GAAP financial measures should be considered in addition to, and not in lieu of, U.S. GAAP financial measures. These non-GAAP financial measures are not based on a comprehensive set of accounting rules or principles. The Company's non-GAAP financial measures may be different from non-GAAP financial measures used by other companies.
About Masimo
Masimo develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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 plans, objectives, strategies and prospects regarding, among other things, the financial condition, results of operations and business of ours and our subsidiaries; the market acceptance of products such as Patient SafetyNet; the value of new measuring new parameters such as PVI; expectations regarding our ability to design and deliver innovative new noninvasive technologies and expand into additional areas of vital signs monitoring and measurements; whether publications from prior independent clinical studies regarding PVI will be duplicated in future studies; and expectations for total revenues, product revenues, GAAP earnings per share and non-GAAP earnings per share for the full fiscal year 2007. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control including: risks related to our reliance on Masimo SET and related products for substantially all of our revenue; risks related to any failure in protecting our intellectual property; risks related to exposure to competitors' assertions of intellectual property claims; risks related to the highly competitive nature of the markets in which we sell our products; risks related to the failure to continue developing innovative products; risks related to the introduction of competing products; risks related to the lack of acceptance of new products, including the Masimo Patient SafetyNet; risks related to the loss of our customers; risks related to increases in prices for raw materials or the loss of key supplier contracts; risks related to the failure to retain senior management or replace lost senior management; risks related to product liability claims exposure; risks related to the absence of expected returns from the amount of intangible assets we have recorded; the risk that our financial performance in the fourth quarter of 2007 may not meet expectations; risks and uncertainties related to the maintenance and strength of our brand; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on September 20, 2007. 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 quarterly report on Form 10-Q for the quarter ended June 30, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.
Masimo Corporation
Investors: Mark P. de Raad Executive Vice President and Chief Financial Officer (949) 297-7080 mderaad@masimo.com
Media: Tom McCall Vice President, Corporate Communications (949) 297-7075 tmccall@masimo.com
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Application, Patient SafetyNet, Rainbow, SpCO, SpMet, PVI, and Pulse CO-Oximeter are registered trademarks or trademarks of Masimo Corporation.
Breaking Studies--Masimo's Technologies the Focus of Multiple Clinical Studies at Last Week's American Society of Anesthesiologists' Annual Meeting
New studies show Masimo provides unique benefits in pulse oximetry, as well as noninvasive blood constituent and functional hemodynamic monitoring
Irvine, California October 25, 2007 - Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that multiple independent and objective clinical studies and a case study were presented last week at the 2007 American Society of Anesthesiology (ASA) Annual Meeting in San Francisco focused on the unique benefits of Masimo's noninvasive patient monitoring technologies in helping clinicians provide improved patient care. These new studies add to the more than 100 independent and objective studies demonstrating the superiority of Masimo SET pulse oximetry, as well as adding to the growing body of research proving the efficacy of Masimo Rainbow SET in providing accurate, reliable physiological measurements of multiple blood constituents that previously required invasive procedures.
Built on the "gold-standard" of Masimo SET Read-Through Motion and Low Perfusion technology, Masimo Rainbow SET is the first and only upgradeable technology platform capable of continuously and noninvasively measuring carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pleth variability index (PVI), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate. Highlights of key study findings include:
Masimo SET and Blue Sensor more accurate and more reliable in cyanotic children
In a study entitled "New Generation and Old Generation Pulse Oximeters in Children with Cyanotic Congenital Heart Disease" a team of anesthesiologists headed by Dr. Maxime Cannesson at the Louis Pradel Hospital in Lyon, France, found that in a study of 10 children ages seven days to 53 months following palliative cardiac surgery, Masimo obtained readings 100% of the time and "Nellcor failed to obtain readings 15% of the time." Additionally, findings showed a "significant difference between the Nellcor SpO2 reading and the blood gas readings," but no significant difference between the Masimo and blood gas readings when compared to laboratory CO-Oximetry. For the 116 arterial samples, the accuracy of the Masimo Radical pulse oximeter was two times better than that of the Nellcor N-395 pulse oximeter, leading researchers to conclude that "new generation pulse oximeters provide more accurate information and are more reliable than old generation pulse oximeters."1
A separate study, entitled "New Pulse Oximetry Sensors with Low Saturation Accuracy Claims - A Clinical Evaluation" performed by Dr. Peter Cox at the Hospital for Sick Children in Toronto, Canada, compared the accuracy of the Masimo Radical with Blue Sensor, the Nellcor N-600 (with Lo-Sat) and Max-I sensor, and the Radical with LNOP sensor to laboratory CO-Oximetry readings on 12 patients with congenital cyanotic cardiac lesions (CCCL) and concluded that "despite advances in technology, only the Masimo Blue sensor demonstrates acceptable accuracy."2 Findings showed that, although the Nellcor N-600 with LoSat is advertised to work in CCCL patients, the accuracy demonstrated in this study was not within Nellcor's published accuracy specifications; whereas the Masimo Radical with Blue Sensor had significantly better accuracy and was within Masimo specifications.
Masimo Rainbow SET provides a noninvasive tool to greatly facilitate the clinical diagnosis and treatment for carbon monoxide poisoning and Benzocaine-induced methemoglobinemia
In a report entitled "Rad-57 Rainbow CO-Oximeter in Detecting Methemoglobin during Upper GI Endoscopy - A Case Report" by Dr. Udaya B. Padakandla at Baylor University Medical Center in Dallas, Texas, the researcher described how four minutes after the Benzocaine application, the patient exhibited a rise in methemoglobin levels above 40% along with a decrease in SpO2 (to 90%), both measured continuously with the Masimo Rainbow SET Rad-57 and confirmed via arterial blood gas analysis. The patient was treated for methemoglobinemia with methylene blue and the SpO2 and methemoglobin levels returned to normal. This case report documents the induction of methemoglobinemia in a GI patient from Benzocaine spray used as a topical anesthetic prior to endoscopy and shows the accuracy and effectiveness of Masimo Rainbow SET to continually and noninvasively measure methemoglobin levels during the entire procedure as confirmed by blood gas with CO-oximetry. This case illustrates the importance of continuous monitoring of SpMet when Benzocaine spray is used.3
In another study entitled "Clinical Analyses of 429 Cases of Acute CO Poisoning," researchers from the Hyperbaric Oxygen Department of Beijing Chaoyang Hospital in Beijing, China, headed by Dr. Zhou Li, used the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter and found that 98 of the 429 acute carbon monoxide (CO) poisoning patients had methemoglobin (MetHb) greater than 1.2 percent at the first measurement with significant positive correlation between CO and MetHb levels, suggesting that "MetHb may be involved in the physiopathological process of hypoxia of acute CO poisoning patients." The application of Masimo Rainbow SET technology in the noninvasive measurement of carbon monoxide and methemoglobin concentration levels in the blood lead researchers to conclude that this technology "provides a noninvasive tool to greatly facilitate the clinical diagnosis and treatment for CO poisoning patients."4
In a study entitled "A Comparison of Finger, Ear and Forehead SpO2 on Detecting Oxygen Desaturation in Healthy Volunteers," by Dr. Kentaro Tokuda and researchers from the Kyushu University Hospital in Fukuoka City, Japan, researchers compared the time for desaturations and resaturations to be detected by Nellcor forehead (MaxFast), Masimo ear (TC-I) and finger (LNOP) SpO2 sensors when patients were in heads-down, supine and heads-up positions. The study found Masimo's ear sensor to be as fast, or slightly faster, than the Nellcor forehead sensor in detecting desaturations and resaturations. The researchers concluded "sensors on the head (forehead and ear), especially Masimo ear sensor, can detect hypoxia as soon as or even sooner than finger," adding that "sensors on the head (forehead and ear) can also sense recovery state from hypoxia sooner than finger."5
In addition, a study entitled "New Algorithm for Automatic Estimation of the Respiratory Variations in the Pulse Oximeter Waveform" conducted at the Louis Pradel Hospital in Lyon, France by a team headed by Dr. Maxime Cannesson demonstrated the ability of Pleth Variability Index (PVI) to accurately and noninvasively detect changes in patient fluid volume. Researchers noted that PVI "has potential clinical applications for noninvasive hypovolemia detection and fluid responsiveness monitoring."6
About Masimo Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-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 have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substanti
