Welch Allyn Expands Patient Monitor Capabilities with Masimo Pulse Oximetry Technology

Beaverton, Ore., and Irvine, Calif., February 9, 2006 - In an effort to continue to meet the challenges caregivers in multiple environments face every day, Welch Allyn, a leading manufacturer of frontline medical products and solutions, announced the availability of Masimo SET® pulse oximetry (SpO₂) in the Vital Signs Monitor 300 Series automated vital signs monitor. The offering marks the latest collaboration between the two companies in a partnership that applies Masimo pulse oximetry technology across a range of Welch Allyn patient monitoring solutions.

"We strive to offer frontline caregivers solutions that maximize their flexibility without changing the way they work," said Doug Linquest, Welch Allyn executive vice president, acute care and Asia. "Adding the option of Masimo SET SpO₂ to the Vital Signs Monitor 300 Series partners the gold standard pulse oximetry technology with one of the most simple, versatile and affordable vital signs monitors out there today."

The Vital Signs Monitor 300 Series is a fully-featured patient monitor that provides simple, automated vital signs measurement before, during, and after medical procedures.

It allows caregivers to either spot-check or continuously monitor patients' blood pressure, temperature, heart rate and pulse oximetry from a single device.

"The Vital Signs Monitor 300 Series is a great product and with it Welch Allyn has satisfied a previously unmet need," said Joe Kiani, Masimo Chief Executive Officer. "We're delighted to have the opportunity to expand our partnership with Welch Allyn, and extend clinician and patient access to Masimo pulse oximetry farther than ever before."

Masimo SET (Signal Extraction Technology) pulse oximetry is a highly advanced method of monitoring the oxygenation of a patient's blood. Masimo technology has been clinically proven to read through motion and low perfusion at a high level of accuracy, with certain studies showing improved patient outcomes.

Welch Allyn offers Masimo SET pulse oximetry in a variety of other products, including the new Spot Vital Signs LXi spot-check device, Propaq CS and Propaq Encore continuous vital signs monitors and the Micropaq wireless telemetry monitor.

"As the trend continues away from hospital-based inpatient procedures to more outpatient procedures and more acute procedures, caregivers need flexible continuous monitoring solutions," Linquest said. "Masimo technology makes the Vital Signs Monitor 300 Series better equipped to meet that need."

About Welch Allyn
Welch Allyn, Inc. was founded in 1915 and is today a leading manufacturer of innovative medical diagnostic and therapeutic devices, cardiac defibrillators, patient monitoring systems, and miniature precision lamps. Headquartered in Skaneateles Falls, New York, USA, Welch Allyn employs more than 2,100 people and has numerous manufacturing, sales, and distribution facilities located throughout the world. Additional information on Welch Allyn and its products may be found at www.welchallyn.com.

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, Signal Extraction Technology and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  Over 100 clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations where competing pulse oximetry devices fail.  Masimo provides its pulse oximetry technology through standalone and handheld monitors and as a monitoring parameter integrated into patient monitors from leading manufacturers, worldwide.   Building on the SET platform, in 2005 Masimo introduced Rainbow SET and with it, Pulse CO-Oximetry, which uses eight wavelengths of light and breakthrough signal processing technology to noninvasively, continuously monitor the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Additional clinically important applications of Rainbow SET are in advanced stages of development. 

Masimo, founded in 1989, has the mission of "Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications."

SET, Signal Extraction Technology and Improving and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Labs. 

Award-Winning Human Volunteer Study Says New Masimo Rainbow SET™ Technology Represents a Major Advance in Patient Monitoring

Scene out of Star Trek: Handheld device detects carbon monoxide poisoning noninvasively, using light waves

IRVINE CA—January 20, 2006 A new study of the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter™, conducted by Steven J. Barker, PhD, MD of the University of Arizona, has received the 2006 Application of Technology award from the Society for Technology in Anesthesia.

The winning study, "New Pulse Oximeter Measures Carboxyhemoglobin Levels in Human Volunteers" evaluated the ability of the Rad-57 to directly measure the effects of carbon monoxide inhalation in humans. The lethal effects of carbon monoxide are caused by the conversion of normal hemoglobin in the blood to an abnormal form called carboxyhemoglobin, or "COHb." Levels of COHb higher than 50% are potentially fatal, and caused the recent deaths of the coal miners in West Virginia. This study compared the COHb readings from the Rad-57 with blood sample measurements made by CO-Oximeters, which are currently used to determine COHb levels in hospital laboratories. The CO-Oximeter is a large, expensive machine that requires a blood sample, whereas the Rad-57 is small, portable, and measures COHb with a simple finger-clip sensor. The Arizona researchers found that the Rad-57™ performed within its specifications, accurately measuring the changing COHb levels in the volunteers' blood. The study concluded that this new technology represents a major advance in the monitoring of oxygenation. This is the second time technology pioneered by Masimo is being honored by the STA with such an award.

Unmasking a silent killer—carbon monoxide—with light waves

"We believe that this device represents a major advance in patient monitoring," said Dr. Barker, the lead author and Head of the Department of Anesthesiology at University of Arizona. "Carbon monoxide poisoning can be a life-threatening problem in the Operating Room, as well as in many settings outside of the hospital. This new technology allows diagnosis in seconds, even in field conditions by first responders. By allowing earlier diagnosis and treatment, this will have a significant effect on patient care."

"We are delighted to hear of the award given to the University of Arizona research team," said Joe E. Kiani, Masimo Chairman and CEO. "Ten years ago, Dr. Barker and Masimo won a similar STA award for Masimo SET®, or Signal Extraction Technology. At that time, our achievement was to monitor oxygen saturation levels accurately for the first time during conditions such as patient motion and low perfusion. Now, building on SET, we are able to monitor carboxyhemoglobin and methemoglobin levels, and soon, we hope, additional vital physiologic parameters, noninvasively. This is history repeating itself in the most encouraging way."

"We are especially pleased that Dr. Barker and his colleagues on the University of Arizona research team have received this recognition," Kiani added. "Dr. Barker is the author of over 150 scholarly works, and one of the leading researchers in oxygen monitoring. To provide Masimo with the scientific advice we need and a strong connection to the medical community, we have invited Dr. Barker to work with us as the Chairman of our Scientific Advisory Board and as a member of the Masimo Board of Directors. I am delighted to say that he has accepted, and we will be able to lead Masimo better with his guidance."

About Masimo

Masimo, the inventor of Pulse CO-Oximetry™ and Read-Through Motion and Low Perfusion Pulse Oximetry, was founded in 1989. Masimo's monitoring systems owe both their superior accuracy and reliability to the company's unique SET (Signal Extraction Technology), a solution the company invented and introduced worldwide in 1998 to address problems that have traditionally beset traditional pulse oximetry systems. Masimo SET allows accurate monitoring despite patient motion, bright lights, signals from other electrical equipment, and low blood flow. These events and conditions, common in adult, pediatric and neonatal patient care, can cause inaccurate readings or loss of readings with less advanced monitoring technology. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.

Masimo's Rainbow™ technology ushers in a new era of non-invasive monitoring, where patients at risk for respiratory and cardiac complications and those suffering from carbon monoxide poisoning and other life-threatening conditions can be quickly diagnosed and treated.

Masimo Signs Three-Year, Dual-Source Agreement with Novation for Pulse Oximetry, and New Masimo Rainbow SET™ Technology

IRVINE, California - February 2, 2006 Masimo today announced that it has signed a three-year, dual-source agreement with Novation, the health care contracting services company of VHA Inc. and the University Health System Consortium (UHC).  The agreement covers Masimo SET® pulse oximetry and Masimo Rainbow SET Pulse CO-Oximetry™, including standalone monitoring devices, handhelds and sensors.   The competitive bid process involved an extensive clinical review and a technology value analysis by Novation's member-based pulse oximetry task force.

Masimo is the inventor of read-through motion and low-perfusion pulse oximetry, a technology called Masimo SET, which has been proven more accurate and reliable in the most challenging clinical settings by over 100 independent clinical studies.  Building on this technology platform, Masimo has recently introduced Masimo Rainbow SET, a new technology that uses eight wavelengths of light to allow clinicians to capture and monitor an unprecedented array of patient physiological data noninvasively.  Rainbow SET capabilities will be available in Masimo monitors and in multi-parameter patient monitors produced by leading manufacturers.

The Rad-57™ Pulse CO-Oximeter™, the first FDA cleared Rainbow SET product from Masimo, is a handheld device that allows clinicians to detect and monitor carbon monoxide levels in the bloodstream non-invasively.  In clinical studies and in the field, Rad-57 is already proving itself effective in detecting carbon monoxide poisoning in seconds, allowing accurate diagnosis and early treatment of a life-threatening problem that is frequently misdiagnosed as flu or migraine.  Masimo has announced that it has other new Rainbow SET monitoring capabilities in advanced development and that the ability to noninvasively detect and monitor methemoglobin levels in the blood is pending FDA clearance.  A recent Johns Hopkins study found that methemoglobinemia, a potentially lethal condition that starves the tissues of oxygen, is much more common in hospitalized patients than previously realized.

"We are happy to announce this new agreement with Novation," said Joe E. Kiani, Masimo's Chairman and CEO.  "Since being added to the Novation contract in 2003, our annualized sales to Novation hospitals has increased by over 5000%, signifying the demand for our technology.  Through this agreement, VHA and UHC members have access to superior Masimo SET pulse oximetry products and Rainbow SET technology that will allow earlier detection and treatment of an expanding number of potentially life-threatening conditions."

"Novation is committed to providing the best purchasing options to VHA and UHC members," said LeAnn Born, vice president of contract and program services for Novation.  "This agreement demonstrates how Novation helps members purchase the latest technologies at lower costs. "

About Novation
Based in Irving, Texas, Novation was established in January 1998 through a combination of the supply programs of VHA and UHC, two national health care alliances.  These organizations used Novation contracts to purchase more than $23 billion in supplies in 2004.

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 SET, and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  Over 100 clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations.  In 2005 Masimo introduced Rainbow SET and with it, 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.

Masimo, founded in 1989, has the mission of "Improving Patient Outcome 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, SET, Signal Extraction Technology and Improving and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Labs. 

Contact:
Brad Langdale
949-297-7009
blangdale@masimo.com

New Study Finds that Carbon Monoxide (CO) Poisoning Can Cause Myocardial Injury and Significantly Increased Long-term Mortality

Irvine, California, February 1, 2006 - Masimo, the inventor and leader of read-though motion and low perfusion pulse oximetry and Pulse CO-Oximetry™ announced an important new study published in The Journal of American Medical Association (JAMA®) by researchers from the Minneapolis Heart Institute Foundation, which demonstrated the acute effects on myocardial tissue and resulting detrimental long term effects on patient outcomes due to moderate and severe carbon monoxide (CO) poisoning. 

Dr. Timothy Henry and a team of researchers studied patients who were treated for moderate to severe CO poisoning.  The study, entitled "Myocardial Injury and Long-term Mortality Following Moderate to Severe Carbon Monoxide Poisoning", found that many patients who were exposed to CO suffered myocardial injury and were three times more likely to die during the follow-up period compared to age and sex specific US mortality rates (mean follow-up period was 7.6 years).

Although moderate and severe CO poisoning is commonly associated with transient or persistent loss of consciousness, brain injury, and other severe neurological symptoms, only myocardial injury and age were found to be significant predictors of mortality in these patients.  All the patients in the study received hyperbaric oxygen therapy and those patients who showed ischemia on electrocardiogram or biomarkers for myocardial injury also received cardiovascular medications.  It is therefore unclear if therapeutic intervention can affect the long-term outcomes of patients who suffer myocardial injury due to CO poisoning.  Nevertheless, the findings of this study contribute to the body of evidence suggesting that healthcare providers should screen all patients potentially exposed to CO for CO poisoning so that the damage due to CO poisoning can be minimized as much as possible by proper intervention. 

"This study underscores the importance of immediate assessment of patients that have been exposed to carbon monoxide," said Joe Kiani, Chief Executive Officer of Masimo.  "Before the introduction of Masimo Rainbow SET™ Pulse CO-Oximetry, the only way for measuring carbon monoxide in the bloodstream was a CO-oximetry test, which required a painful blood draw and potentially significant delays in diagnosis.   And even though CO poisoning is the most common type of accidental poisoning in adults in the US, many hospitals do not even have invasive CO-oximeters on site.  With the introduction of the Masimo Rainbow SET Pulse CO-Oximetry, hospital clinicians and first responders now have a noninvasive portable monitor that can be used anywhere to quickly diagnose and monitor carbon monoxide poisoning painlessly."

Maribeth Sayre, MD, Director of Medical Affairs of Masimo added, "CO poisoning is not only potentially fatal, but for those who survive it, treatment must be instituted immediately if long term neurological damage, and perhaps myocardial damage, is to be avoided.   Dr. Henry's research is providing very important information to the medical community.  A common misconception regarding CO poisoning is that it can be prevented and effectively dealt with by installing airborne CO detectors.  While these devices are critical to protecting people against being overcome by extreme CO levels, they may not detect lower levels of CO.  The problem is that even small amounts of CO accumulate in the blood very quickly and dissipate very slowly, so long-term or repeated exposure to low levels of CO can lead to toxic levels accumulated in the blood.  Anyone with classic CO poisoning symptoms of dizziness, headaches, shortness of breath, fatigue and nausea should be screened for CO poisoning.  Now with Rainbow SET, CO detection and monitoring can be done quickly and painlessly."

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 SET, and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  Over 100 clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations.  In 2005 Masimo introduced Rainbow SET and with it, 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.

Masimo, founded in 1989, has the mission of "Improving Patient Outcome 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, SET, Signal Extraction Technology and Improving and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Labs. 

Contact:
Brad Langdale
949-297-7009
blangdale@masimo.com

Masimo and Nellcor Announce Settlement of Patent Litigation

IRVINE, California - January 23, 2006, Masimo today announced a settlement of all existing patent litigation with Nellcor, a division of Tyco Healthcare.  Under the terms of the settlement, all pending patent litigation will be dismissed, and Nellcor has paid Masimo $265 million for damages through January 31, 2006.  In addition, Nellcor made an advance royalty payment of $65 million related to sales of Nellcor's new products during the remainder of calendar 2006.  After January 31, 2006, Nellcor will no longer ship its current 05 pulse oximetry platform, but it will continue to provide service and sensors for previously sold products.  Masimo has granted Nellcor the right to sell Nellcor's new line of pulse oximetry products in exchange for an ongoing royalty.

About Masimo
Masimo, the inventor of Pulse CO-Oximetry™ and Read-Through Motion and Low Perfusion Pulse Oximetry, was founded in 1989. Masimo's monitoring systems owe both their superior accuracy and reliability to the company's unique SET^® (Signal Extraction Technology), a solution the company invented and introduced worldwide in 1998 to address problems that have traditionally beset conventional pulse oximetry systems. Masimo SET allows accurate monitoring despite patient motion, bright lights, signals from other electrical equipment, and low blood flow. These events and conditions, common in adult, pediatric and neonatal patient care, can cause inaccurate readings or loss of readings with less advanced monitoring technology. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.

Masimo Rainbow SET™ technology ushers in a new era of non-invasive monitoring, where patients at risk for respiratory and cardiac complications and those suffering from carbon monoxide and methemoglobin poisoning and other life-threatening conditions can be quickly diagnosed and treated.

Contact: Brad Langdale 949-297-7009

Clinical Update: An Invisible Epidemic

Two weeks ago, the tragic news of the 12 West Virginia coals miners who died as a result of carbon monoxide (CO) poisoning, reminded us what a lethal threat is posed by this gas, the most frequent cause of accidental poisoning. Every winter, local papers carry stories of entire families fatally poisoned at home by malfunctioning furnaces or space heaters.

Subacute, chronic CO poisoning is less visible, but may be much more common. In many cases, victims are unaware that they are being poisoned and may easily be misdiagnosed or never examined by health care professionals. With the March 2005 introduction of the Rad-57™ Rainbow SET Pulse CO-Oximeter™, which allows noninvasive diagnosis of carbon monoxide levels in the community as well as in the Emergency Department, Masimo has received field reports of carbon monoxide poisoning diagnosed in numerous people who were asymptomatic or only mildly symptomatic.

A toxic firehouse

In November, a Masimo representative was conducting a Rad-57 inservice for a group of Midwestern firefighters whose Department had purchased units to use in firefighter rehabilitation. CO readings were normal for the fire chief and several other firefighters attending the inservice, but were elevated with three individuals who were stationed at the same firehouse. None of the men smoked. The group's first reaction was to question the accuracy of the Rad-57 readings, but when questioned, all three men admitted that they had been feeling slightly ill in recent weeks. Later, it was discovered that a hose installed to vent tail pipe exhaust from the fire engine was defective. Fire engines are often kept running in the fire apparatus bays before calls, one floor beneath the firefighters' living and working areas.

The poisoned firefighters were well acquainted with the dangers of CO poisoning, trained to protect themselves from inhaling the gas during fires, but they never associated the mild flu-like symptoms they were experiencing with carbon monoxide poisoning, nor had they mentioned their symptoms to others. "It's the macho tradition," one said.

After the venting system was repaired, the men continued to be monitored with the Rad-57—their CO readings returned to normal.

A potentially deadly commute

In December, an EMS team in a Rocky Mountain town made a similar "save". They were conducting an inservice on their newly acquired Rad-57 unit to a number of public service employees, demonstrating how smokers routinely recorded elevated CO levels. One attendee, a non-smoker, showed markedly elevated levels of carboxyhemoglobin. Alarmed, the EMS team contacted the local Fire Department, which tested the woman's house for carbon monoxide gas—with negative results.

Investigating further, the Fire Department tested the woman's car with the engine running and found that the passenger compartment was heavily contaminated by carbon monoxide—the exhaust system was defective. Winter temperatures in the mountains were below zero many days, and the poisoned woman was in the habit of warming her car up for ten minutes when she commuted back and forth to work. During every morning and evening trip she was exposed to high levels of carbon monoxide, at risk of a lapse in consciousness while driving on icy mountain roads.

Like the firemen, the poisoned woman had been feeling "not quite right" lately, but had decided that she was just coming down with a cold.

Unmasking the Great Imitator

For clinicians, diagnosing carbon monoxide poisoning from symptoms can be extremely difficult. Symptoms reported by poisoned patients are often identical to those reported by people with colds, flu, migraine, food poisoning and a host of other ailments.

Consequently, the National Academy of Clinical Biochemistry recommends that clinicians routinely assess the percentage of blood carboxyhemoglobin by cooximetry to screen patients with flu-like symptoms in the Emergency Department, particularly in communities where combustion is used for heating during the heating season. Co-oximetry requires a blood sample be taken in a hospital setting and sent to the lab for analysis. With the introduction of Rad-57 Pulse CO-Oximetry, testing is painless, inexpensive and can be completed in seconds. The routine use of pulse CO-Oximetry by ED, EMS and other health care professionals can play an important role in identifying undetected carbon monoxide poisoning, helping reduce morbidity and mortality and preventing the long term neurological damage that can occur through repeated CO exposure.

Happy Holidays from Masimo!

This has been an exciting and successful year for Masimo and we wish to share our success with charitable organizations that you choose by making a donation to them on your behalf.

We look to our Guiding Principles in pursuit of this Mission:

• 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!

Clinical Studies Find New Masimo Rainbow Technology Effective in Detecting Carbon Monoxide Poisoning

--Lifesaving medical first, the Masimo Rad-57™ detects carbon monoxide (CO) poisoning in seconds

IRVINE CA, December 7, 2005 - Two independent clinical studies, recently presented at the American Association for Respiratory Care (AARC) Congress, found that the Masimo Rainbow SET^® Rad-57 Pulse CO-Oximeter™ was effective in detecting carbon monoxide levels in the bloodstream.  The Rad-57 sensor, applied to a patient's finger, determines blood carbon monoxide levels in seconds, using multiple wavelengths of light.   The Rad-57 is the first noninvasive device FDA-cleared for detecting carbon monoxide levels in the bloodstream.  In addition, the Rad-57 also measures oxygen saturation, pulse rate and perfusion index.

In the first study, researchers from the Mayo Clinic attached the Rad-57 sensor to patients' fingers, recorded the CO readings, drew arterial blood samples that were analyzed within fifteen minutes in a blood analyzer, and compared the results   Mayo researchers concluded that the Rad-57 analyzed blood carbon monoxide levels accurately and stated that it would be helpful in situations where non-invasive monitoring of CO levels would be beneficial.

A study by researchers at Rhode Island Hospital & Brown Medical School, Department of Emergency Medicine reported on the use of the Masimo Rad-57 CO-Oximeter in treating the victim of a house fire.  The initial measurement indicated that approximately 40% of the patient's blood supply had been poisoned with carbon monoxide, a highly dangerous level. Using the Rad-57 monitor, clinicians continuously monitored CO levels in the bloodstream noninvasively while the patient received oxygen therapy, allowing them to know that the treatment was working and when it could be stopped.  After nearly 3 hours of treatment, the patient's CO level was less than 5%.  Researchers concluded that the Masimo Rad-57 demonstrated the ability to continuously and noninvasively monitor carbon monoxide levels in the blood.

"We are very pleased to see the performance of the Rad-57 independently validated by these leading institutions," said Joe E. Kiani, Masimo CEO and Chairman. "For the first time, hospitals, first responders and industrial health care professionals will be able to quickly and noninvasively determine whether patients or firefighters are experiencing carbon monoxide poisoning.  We are proud to, once again, introduce technology that will save lives and prevent disability."

Unmasking the Great Imitator-CO
Carbon monoxide, a silent, odorless killer, is the leading cause of accidental poisoning deaths in the US, responsible for an estimated 5,000 fatalities and 10,000 poisoning injuries annually. Since carbon monoxide is produced by combustion, it can be a threat both at home, usually from faulty furnaces or water heaters and in the workplace, where exhaust fumes from motor vehicles and manufacturing equipment can accumulate.  Because carbon monoxide is produced in huge quantities in building and forest fires, firefighters face especially high risk of repeated exposure to carbon monoxide.  

Carbon monoxide poisoning can be very difficult to diagnose, since its symptoms resemble those of the flu and other common ailments.  Sometimes symptoms are so subtle that patients ignore them, which can have life-threatening consequences. Quick diagnosis and treatment of carbon monoxide poisoning is critically important in saving lives and preventing long-term neurological damage.  Quick diagnosis of a poisoned patient may also allow paramedics, firefighters and clinicians in the Emergency Department to identify other persons at risk in a toxic home or work environment, and intervene before it is too late. 

Unfortunately, conventional pulse oximeters cannot distinguish carbon monoxide from oxygen, and report erroneous high oxygen levels, even when patients are severely poisoned with carbon monoxide.

Before the introduction of the Rad-57, the gold standard for measuring carbon monoxide concentration in the bloodstream was a CO-Oximetry test, which required a painful blood draw and potentially significant delay in diagnosis. Many US hospitals do not have CO-Oximeters on site.

With the introduction of the Rad-57 pulse CO-Oximeter, hospital clinicians and first responders in the field now have a portable, durable unit that can be used anywhere to diagnosis carbon monoxide poisoning painlessly, in seconds.

About Masimo
Masimo, the inventor of Pulse CO-Oximetry™ and Read-Through Motion and Low Perfusion Pulse Oximetry, was founded in 1989. Masimo's monitoring systems owe both their superior accuracy and reliability to the company's unique SET (Signal Extraction Technology), a solution the company invented and introduced worldwide in 1998 to address problems that have traditionally beset traditional pulse oximetry systems. Masimo SET allows accurate monitoring despite patient motion, bright lights, signals from other electrical equipment, and low blood flow. These events and conditions, common in adult, pediatric and neonatal patient care, can cause inaccurate readings or loss of readings with less advanced monitoring technology. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.

Masimo's Rainbow™ technology ushers in a new era of non-invasive monitoring, where patients at risk for respiratory and cardiac complications and those suffering from carbon monoxide poisoning and other life-threatening conditions can be quickly diagnosed and treated.

More information about Masimo and its products can be found at www.masimo.com.

Masimo Contact:  Larry Watts 949-297-7041   lwatts@masimo.com

Breaking Pulse CO-Oximetry and Pulse Oximetry Studies of Interest at AARC

Since the 2004 AARC meeting, we thought you might be interested in a brief description of clinical studies and presentations on Masimo technology that will be presented at the upcoming AARC meeting, including two independent clinical studies on the new Masimo Rainbow SET RAD-57™ Pulse CO-Oximeter, which non-invasively detects carboxyhemoglobin (SpCO™) as well as oxyhemoglobin (SpO₂), pulse rate and perfusion index. In addition a ground breaking study will be presented on a pulse oximetry sensor, Masimo SET LNOP Blue™ sensor, designed for cyanotic infants.

Saturday December 3, 2005
Open Forum #1 Monitoring        12:30-2:55 PM

COMPARISON OF THE MASIMO RAD-57 PULSE OXIMETER WITH SPCO TECHNOLOGY AGAINST A LABORATORY CO-OXIMETER USING ARTERIAL BLOOD
Carl D. Mottram RRT, RPFT, FAARC, Lori J. Hanson RRT, CPFT, Paul D. Scanlon MD
Mayo Clinic, Rochester MN
"Conclusion: The Masimo Rad-57 pulse oximeter measures functional oxyhemoglobin (SpO₂) (p<0.001) and SpCO (p<0.015) accurately."
 

Saturday December 3, 2005
Open Forum # 3 Case Reports: Part One   3:00-4:55 PM

CARBON MONOXIDE POISONING DETECTED AND MONITORED CONTINUOUSLY AND NONINVASIVELY: A CASE REPORT
Troilus Plante MD, Darcy Harris DO, James Monti MD, Robert Tubbs MD, Gregory D. Jay MD, PhD: Rhode Island Hospital & Brown Medical School, Department of Emergency Medicine
"Victim of a house fire was treated in the ED for smoke inhalation...The Case demonstrates the clinical utility of bedside pulse CO-oximetry in a patient suffering from CO poisoning." 

Monday December 5, 2005
Open Forum #11 Neonatal Pediatric Part Two   12:30-2:25 PM

CLINICAL TRIAL OF A NEW PULSE OXIMETRY SENSOR DESIGNED FOR USE ON CHILDREN WITH CONGENITAL CYANOTIC CARDIAC DISEASE:
Cox PN MD, Fernandez K MD, Hospital for Sick Children, Toronto Canada
"Despite advances in technology, previous oximeters were inaccurate in the range of saturations found in this patient population.  The new Masimo Blue Sensor™, designed for use specifically in this patient population, is more accurate as demonstrated by a smaller bias and precision than the standard LNOP sensor."

VISIT US AT AARC - BOOTH 1203

If you are attending AARC this year, please stop by our Booth # 1203.  We are featuring Masimo SET® Rainbow™ Pulse CO-Oximetry technology, the first non-invasive monitoring technology FDA-cleared for measuring carbon monoxide levels in the blood and Masimo SET with LNOP Blue, the first accurate pulse oximeter for cyanotic babies.  We are also showcasing RadNet™,  a central monitoring system for the general care floor based on Masimo SET technology, the gold standard in pulse oximetry.

Breaking Study: Masimo Technology Represents a Significant Advance in the Care of Infants with Congenital Heart Disease

One of several comparison studies on Masimo patient monitoring technology presented at the 2005 American Society of Anesthesiology Annual Meeting

Irvine, California November 1, 2005 - Masimo reported that a new study, presented last week at the 2005 American Society of Anesthesiology (ASA) Annual Meeting in Atlanta, demonstrates the value of its highly accurate monitoring technology in caring for infants with congenital heart disease.  

Texas Children’s Hospital Study - "Substantial Improvement in Accuracy" with Masimo

Accurate monitoring of blood oxygen levels is especially important in the care of critically ill infants.   Pulse oximeters, developed in the 1980’s to allow continuous monitoring of patients’ blood oxygen levels, have posed significant challenges for clinicians especially in neonatal care.  With conventional pulse oximetry technologies, patient motion and low blood circulation in feet or hands can produce inaccurate monitoring results.  Infants and children with cyanotic (insufficient oxygen in their bloodstream) heart disease have been extremely difficult to monitor accurately.

On October 24, 2005 at the ASA conference, an independent research team from Texas Children’s Hospital at Baylor College of Medicine presented study results on the Masimo SET LNOP Blue Sensor, which is the first device of its kind specifically designed - and cleared by the FDA - for accurately monitoring blood oxygen levels in cyanotic infants.  The study compared the performance of the Masimo SET Blue Sensor, attached to a Masimo SET Radical Pulse Oximeter, with that of the OxiMax Max-I sensor attached to Nellcor’s N-595 pulse oximeter in patients with cyanotic heart disease.  Comparing the monitoring performance of both technologies with blood test results, investigators found that the Masimo technology was significantly more accurate.  The Masimo SET Radical and Blue Sensor exhibited a bias of 0.17 % compared with a bias of 5.63% for the Nellcor device.  Masimo’s precision was also significantly better, 2.51% compared to 5.24 % for the Nellcor N-595.  In an abstract of their study presentation at ASA, researchers stated that Masimo technology “represents a significant advance in the care of this complicated group of patients”.

Gina Whitney MD, one of the researchers, commented on the study presented at ASA, "Our research found that the Masimo SET Radical and the Blue Sensor provided a substantial improvement in accurately monitoring children with cyanotic congenital heart disease.”  Dr. Whitney, currently Assistant Professor of Pediatrics and Anesthesia at Vanderbilt Children’s Hospital, conducted the study while working in the division of Pediatric Intensive Care at Texas Children’s Hospital in Houston Texas.

News of Masimo’s superior performance spread quickly through the hospital during the study. “The other cardiac intensive care physicians were so impressed with the performance that they began 'borrowing' the study oximeter for use in other critically ill patients who were not enrolled,” said Dr. Whitney.  

"Accuracy and reliability in monitoring oxygen levels is especially important in these fragile patients,” said Maribeth P. Sayre MD, Director of Medical Affairs at Masimo. Developing technology specifically designed to help clinicians provide optimal care for these children has been a top priority for Masimo.  We are delighted that independent clinical research shows that we are succeeding.”

Comparison studies also document superior Masimo performance with adults.

Other studies presented at ASA compared Masimo with “new generation” pulse oximeters from Nonin and Philips.  A research team at Long Beach VAHS & University of California at Irvine Medical Center, led by Nitin Shah MD, examined the performance, accuracy, failure rate and recover time of the Masimo Radical (rev 4.3), the Nonin 9700 (2004) and the Philips CMS (FAST rev C.1) oximeters. Volunteers were tested in a cooled room (16-18 degrees Centigrade), an environment that lowered blood circulation in feet and hands.   The study participants were connected to all three pulse oximeters, which were compared to control oximeters. During different types of motion, low perfusion (blood circulation) and hypoxia (low blood oxygen levels), researchers measured differences from the control devices.  The Masimo SET Radical pulse oximeter performed significantly better than both the Phillips and the Nonin technologies during all parts of the test, and the Masimo SET Radical was the only device that did not zero out (fail to report readings) during any test.

"Masimo SET technology has been repeatedly tested against competitive technologies, worldwide. Time after time, in neonatal, pediatric or adult care, research proves that no other oximetry technology matches the performance of Masimo SET,” said Mike Petterson, Masimo Vice President of Clinical Research.

About Masimo
Masimo, the inventor of Pulse CO-Oximetry^™ and Read-Through Motion and Low Perfusion Pulse Oximetry, was founded in 1989.  Masimo’s monitoring systems owe both their superior accuracy and reliability to the company’s unique SET (Signal Extraction Technology), a solution the company invented and introduced worldwide in 1998 to address problems that have traditionally beset traditional pulse oximetry systems.  Masimo SET allows accurate monitoring despite patient motion, bright lights, signals from other electrical equipment, and low blood flow.  These events and conditions, common in adult,  pediatric and neonatal patient care, can cause inaccurate readings or loss of readings with less advanced monitoring technology.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

Masimo’s Rainbow^™ technology ushers in a new era of non-invasive monitoring, where patients at risk for respiratory and cardiac complications and those suffering from carbon monoxide poisoning and other life-threatening conditions can be quickly diagnosed and treated.

More information about Masimo and its products can be found at www.masimo.com.  

Contact:
Brad Langdale
Masimo Corporation
949-297-7009

Spacelabs Medical and Masimo Announce Latest Pulse Oximetry Technology Alliance

Issaquah, Wash., and Irvine Calif., September 19, 2005 - Spacelabs Medical, a leading manufacturer and distributor of patient monitoring systems, announced the availability of Masimo SET^® SpO₂ technology in Spacelabs' Ultraview_SL Command Module.  The new product offering is the latest step in the two companies' joint development initiatives, designed to provide "best in class" solutions for customers worldwide.    

Masimo SET (Signal Extraction Technology) pulse oximetry is a highly advanced method of acquiring, processing and reporting arterial oxygen saturation and pulse rate.  Combining proprietary signal processing algorithms with innovative sensor design, Masimo SET pulse oximetry enables adaptive filters to work in real time to accurately report changes in human physiology.  Masimo SET SpO₂ technology has been clinically proven to read through motion and low perfusion at a high level of accuracy, with some studies showing improved patient outcomes.

Spacelabs' Ultraview_SL family of patient monitoring systems, including the SL2400 compact, SL2700 and SL2800 bedside monitors and SL3800 central monitor for hardwired, wireless and telemetry patients, enable clinicians to access customized, real-time patient data when and where it is needed.   

Dave Tilley, President and COO of Spacelabs Medical, said, "We are pleased to offer Masimo's technology to Spacelabs customers throughout the world.  We are committed to satisfying our customers with the solutions that best meet their needs.  The agreement with Masimo is yet another example of this 'Customer First' philosophy."

Joe E. Kiani, CEO of Masimo Corporation, added, "Spacelabs Medical has a history of leadership and is poised to continue with its heritage.  We are happy that together with Spacelabs, we can offer more clinicians and patients access to Masimo SET pulse oximetry."

About Spacelabs Medical

Spacelabs Medical (www.spacelabs.com), based in Issaquah, WA, U.S., is a global manufacturer and distributor of patient monitoring systems for critical care and anesthesia, wired and wireless networks and clinical information connectivity solutions, ambulatory blood pressure (ABP) monitors and medical data services.  It has an installed base of approximately 100,000 patient monitoring units worldwide, including around 60,000 in the U.S. and around 10,000 units in Europe.  In addition, there are approximately 30,000 Spacelabs ABP monitors installed on a worldwide basis.  Spacelabs has distribution partnerships in approximately 80 countries and sales or regional offices worldwide.  Spacelabs employs approximately 800 employees worldwide.  Spacelabs Medical is an OSI Systems Company, www.osi-systems.com.

About Masimo

Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo Prevails in Patent Appeal

Irvine, California, September 8, 2005 - Masimo^®, the inventor of Pulse CO-Oximetry™ and Read-Through Motion and Low Perfusion Pulse Oximetry, announced that the United States Court of Appeals for the Federal Circuit (CAFC) denied Nellcor's appeals and affirmed the findings by the Federal District Court in Los Angeles that Nellcor (a Tyco company) infringes two Masimo patents.  Further, the CAFC reinstated a jury verdict that Nellcor infringes a third Masimo patent.  The products found to infringe are Nellcor's O4 (Oxismart XL), O5 and O5ci (Oximax) technologies.  Oxismart XL and Oximax technology are found in certain Nellcor pulse oximetry products, such as the N-595, N-395, N-550 and NPB40 pulse oximeters, as well as technology offered through OEM patient monitoring companies, such as the MP404, MP505, MP506, and MP100.  Finally, the CAFC instructed that a permanent injunction be entered against Nellcor's products found to infringe Masimo's patents.

The initial jury verdict included damages of over $134M for infringing products shipped through December of 2003.  The final judgment from the Federal District Court in Los Angeles specified damages of over $164M, based upon infringing products shipped through May of 2004.  The damages have also been accruing since the final judgment in 2004 while a permanent injunction was not in place.

"We are grateful for the laws and the courts that have helped us protect our inventions," stated Joe E. Kiani, Founder and CEO of Masimo.  "Masimo made a significant contribution to patient care and safety with its innovations.  If others were permitted to profit from such breakthroughs and inventions, future innovation and ultimately patient care would suffer.  We are very happy that the appellate court has issued this important decision."

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology^® for the non-invasive monitoring of vital signs.  Masimo Signal Extraction™ Technology, or Masimo SET^®, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.

With the advent of Rainbow™ Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry™.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

FDA Clears Masimo SET LNOP Blue Sensor, The First and Only Pulse Oximeter Sensor to Accurately Monitor Cyanotic Babies

Irvine, California, August 25, 2005 - Masimo^®, the inventor of Pulse CO-Oximetry^™ and Read-Through Motion and Low Perfusion Pulse Oximetry, announced an important milestone for care of cyanotic infants and children with the FDA clearance of the Masimo SET LNOP^® Blue sensor.  Upon review of clinical data gathered from leading children's hospitals, the FDA has cleared the LNOP Blue Sensor for measuring the oxygen saturation of arterial blood (SpO2) in pediatric, infant and neonatal patients with congenital cardiac lesions with accuracy of 3% from 100% to 80% and accuracy of 4% from 80% to 60%.  Due to the unique physiology and critical condition of these patients, accurate monitoring of SpO2 has not been possible.  Prior to the introduction of Masimo SET LNOP Blue sensor, pulse oximeters' inaccuracies were as high as 15%¹ on cyanotic patients.

Peter Cox, MD, Clinical Director, Pediatric Intensive Care Unit, Hospital for Sick Children in Toronto, Canada stated, "We have tested this new Blue sensor for over 12 months on many cyanotic babies with oxygen saturations in the 60% to 80% range. We have compared the readings from the Masimo sensor to values obtained from the gold standard, invasive CO-Oximetry.  This new sensor has remarkable precision and accurately tracks the arterial oxygen saturation to low levels. In the past, oximeters have been inaccurate in this range. We even had a case where the Blue sensor accurately tracked arterial saturation to the low 30% range. These cyanotic patients are very difficult to monitor and this new sensor helps us more accurately assess these patients' oxygenation status."

Anthony C. Chang, M.D., M.B.A., Director, Pediatric Cardiac Intensive Care Unit, Texas Children's Hospital added "Masimo has really led the charge in developing technological advances that would accurately measure pulse oximetry in cyanotic heart disease patients. This advance enables the physicians and nurses taking care of cyanotic patients to deliver proactive critical care medicine."

The Masimo SET LNOP Blue Sensor is the first sensor designed specifically for cyanotic babies.  The LNOP Blue sensor is the first and only sensor to receive accuracy claims for cyanotic infants and children.  Cyanotic infants and children have long presented challenging conditions for reliable and accurate pulse oximetry, and Masimo's research team recognized years ago that the robust and sensitive capabilities of Masimo SET might represent a critical solution for this group. The LNOP "Blue" project was undertaken based on clinicians' request, patient need, and Masimo's patient focused philosophy.

Mike Petterson, RRT and Vice President of Clinical Research of Masimo, stated, "Several independent studies will soon be published on the clinical accuracy of the Masimo SET LNOP Blue sensor.  These studies investigate the accuracy and precision of the Masimo SET LNOP Blue sensor in caring for cyanotic patients, where the correct amount of oxygenation could have a huge impact on the outcome of these cyanotic children.  It's great to work for a quality company with great people who can make a difference in peoples' lives."

Maribeth Sayre, MD, Director of Medical Affairs of Masimo, stated:  "Management of cyanotic infants and children has been difficult without an accurate measurement of oxygen saturation other than painful, expensive, and intermittent arterial blood gases.  Now there is a reliable, accurate, non-invasive method of continuously assessing oxygen saturation changes associated with different treatments and varying clinical conditions.  This could have a profound effect on the care and outcome of these often fragile patients.  The Blue sensor is in keeping with Masimo's guiding principles which include: Do what is best for patient care."

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology^® for the non-invasive monitoring of vital signs.  Masimo Signal Extraction^™ Technology, or Masimo SET^®, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

With the advent of Rainbow^™ Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry^™.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

1 Oliver  Jr WC, Puga FJ, Schroeder DR, Beighley CM, Dearani JA, Ereth MH, Nuttal GA, Barnes RD, Belau MM. Accuracy and Precision of Masimo SET, Agilent Merlin, and Nellcor N-395 Pulse Oximeters in Patients Undergoing Cardiopulmonary Bypass for Congenital Heart defects. Anesth Analg 2003;96, SCA135       

Masimo, Signal Extraction Technology, SET and LNOP are registered trademarks of Masimo Corporation. Signal Extraction and LNOP Blue are trademarks of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.

New Study Finds that Masimo SET Perfusion Index May Help Detect Subclinical Chorioamnionitis in Newborns, Alerting Clinicians and Speeding Treatment

Irvine, California, June 8, 2005 - Masimo®, the inventor and leader of read-through motion and low perfusion pulse oximetry and Pulse CO-Oximetry™, announced important new research that could facilitate the prompt identification and treatment of dangerous perinatal infections that are largely subclinical. Using the Masimo SET Radical Pulse Oximeters, researchers at the Siena and Brindisi Hospitals, Italy, showed that during the first minutes of life, Masimo SET perfusion index (PI) is a valuable tool in detecting the presence of subclinical chorioamnionitis1.

Chorioamnionitis (CA) is an infection typical in the second half of gestation that has been related to preterm labor/delivery leading to premature birth and other serious neonatal complications2-6.  It can be found in both the mother and the fetus.  In some cases CA in the fetus remains at levels too low to be detected, which is referred to as subclinical CA.  Detecting this condition immediately after birth is important to avoid the advancement of infection during the first hours and days of life.

Based upon previous observations and studies which showed that the Masimo SET pulse oximeter PI can be useful as a new illness severity tool in the newborn7, researchers Claudio De Felice, Antonio Del Vecchio, Mario Criscuolo, Antonia Lozupone, Stefano Parrini and Giuseppe Latini theorized that changes in PI levels early in life would occur in term newborns with subclinical CA. To test the theory, the team set up a study in two phases at the Brindisi Perrino Hospital. In the first phase, numerous measurements, including Masimo SET PI, were recorded in groups of patients already diagnosed to have subclinical CA or to be subclinical CA-free. Phase two of the study evaluated 329 unselected newborns, to see if significant correlations could be found between PI measurements and the subsequent diagnosis and severity of subclinical CA.

Masimo SET PI was found to be an early and accurate predictor of subclinical CA in term infants. Of the patients suspected of having subclinical CA in the study phase 2, 93.7% were confirmed positive, while 0% of those expected to be clear tested positive. Further, of those diagnosed with the condition in phase 2, 6.2% were admitted to the NICU, compared with 29.4% during the screening in phase 1. The researchers stated that the early monitoring of PI could help physicians detect these high-risk newborns, leading to a significant reduction in the initial illness severity and therapeutic intensity during the first 24 hours, and a decreased length of stay in the NICU.

Maribeth Sayre, MD, Masimo's Director of Medical Affairs stated, "We commend Dr. De Felice and his team for this groundbreaking research.  We look forward to additional testing to confirm these findings and also determine the value of Masimo SET Perfusion Index in influencing patient outcomes."

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology® for the non-invasive monitoring of vital signs.  Masimo Signal Extraction™ Technology, or Masimo SET®, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

With the advent of Rainbow™ Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry™.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next-generation pulse oximetry.  If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry.  Contact Masimo for more details.

Masimo, Signal Extraction Technology and SET are registered trademarks of Masimo Corporation. Signal Extraction is a trademark of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories. 

1  De Felice C, Del Vecchio A, Criscuolo M, Lozupone, A, Parrini S, & Latini G.  Early postnatal perfusion index changes in term newborns with subclinical chorioamnionitis. Arch. Dis. Child. Fetal Neonatal Ed. Published online 29 Apr 2005; doi:10:1136/adc.2004.068882

2  De Felice C, Toti P, Parrini S, Del Vecchio A, Bagnoli F, Latini G, Kopotic RJ. Histologic chorioamnionitis and severity of illness in very low birth weight newborns. Pediatric Crit Care Med. 2005 May;6(3):298-302.

3  Toti P, De Felice C, Occhini R, Schuerfeld K, Stumpo M, Epistolato MC, Vatti R, Buonocore G. Spleen depletion in neonatal sepsis and chorioamnionitis. Am J Clin Pathol. 2004;122:765-71.

4  Presta G, Rosati E, Giannuzzi R, Del Vecchio A, Lozupone A, Criscuolo M,
Verrotti A, Latini G, De Felice C. Prolonged fetal bradycardia as the presenting clinical sign in Streptococcus agalactiae chorioamnionitis. J Perinat Med. 2004;32:535-7.

5  De Felice C, Latini G, Ginanneschi C, Santopietro R, Toti P, Fanetti G, La Gamma ML, Bagnoli F. Subclinical chorioamnionitis: an unrecognised risk factor for severe pulmonary haemorrhage in extremely low birth weight infants. Eur J Pediatr. 2005 Feb;164(2):111-2. Epub 2004 Oct 02.

6  De Felice C, DiLeo L, Parrini S, Latini G. Persistent fetal heart rate hypovariability: A presenting clinical sign of histologic chorioamnionitis at term gestation. J Mat Fet Neon Med. 2004;16(6):363-365.

7  De Felice C, Latini G, Vacca P, Kopotic RJ. The pulse oximeter perfusion index as a predictor for high illness severity in neonates. Eur J Pediatr. 2002 Oct;161(10):561-2. Epub 2002 Sep 3.

Masimo Announces Accredited Online Lecture

Irvine, California, May 17, 2005 - Masimo®, the inventor and leader of read-through motion and low perfusion pulse oximetry and Pulse CO-Oximetry™, has announced the first in a series of accredited webcast lectures, scheduled for Thursday, May 19th, as a part of Masimo's commitment to provide continuing education related to advancements in noninvasive monitoring.  Masimo is making a significant investment in its web-based education center, MasimoU.com™, in order to increase the breadth of education events and on-line training materials to satisfy its commitment to the continuing education needs of its customers.

This Thursday's lecture is titled "Oxygen Transport and Neonatal Pulse Oximetry", and will be presented by Dr. William Hay Jr., Professor of Pediatrics and Scientific Director of the Perinatal Research Center at the University of Colorado.  Dr. Hay attended Yale University School of Medicine, after which he completed his Residency and Fellowship at the University of Colorado.  He is certified by the National Board of Medical Examiners, the American Board of Pediatrics and the Sub-Board of Neonatal-Perinatal Medicine. Dr. Hay has authored or co-authored over 400 scholarly papers, abstracts and reviews, over 20 books, and is credited with dozens of additional published works. He is recognized as one of the world's leading authorities on the clinical use of pulse oximetry in the neonatal population.

"The Internet and webcasting technology are great tools for getting important information out to busy clinicians," explains Dr. Hay.  "Masimo has shown a sincere commitment to maximizing the potential of this medium, much as they have in the advancement of noninvasive monitoring with breakthroughs like Masimo SET® Pulse Oximetry.  I was glad to agree to initiate their new lecture series with this presentation, and I anticipate working with Masimo on future training activities."

"We are very pleased to have Dr. Hay initiate this series," said Dr. Gary L. Clawson, Masimo's Director of Clinical and Professional Development. "This is the first in a series of webcasts that we will deliver as a part of Masimo's commitment to education and development.  In addition to these events, we will also launch online training tools, pre-recorded lectures and other materials as part of  'Masimo U', and we have already received accreditation for a number of our education initiatives."

Accreditation allows a variety of clinicians and others involved in the patient care process to receive credits for continuing their education and keeping their credentials current. While not all types of on-line training can include accreditation, Masimo has already received approval from virtually every state in the nation for key parts of its program.  Announcements regarding new events, e-learning programs and e-inservicing materials are expected throughout the summer.

"We at Masimo are proud to offer a new level of education opportunities to meet the needs of our customers," said Joe E. Kiani, Masimo's CEO. "Delivering innovative and reliable noninvasive monitoring solutions is our fundamental business, but we recognize that keeping clinicians informed on the very latest research and knowledge regarding how to best utilize these new advancements is of equal importance.  With Masimo U and our accredited lecture series, we can leverage the power of the Internet to conveniently reach the widest possible audience.  Our goal is to advance the knowledge and education of clinicians and others involved in the delivery of patient care who have an interest and take the time to participate."

For information on how to participate in Thursday's program, or future events, visit MasimoU.com. Space is limited, so applicants will be accommodated on a first-come, first-served basis.

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

With the advent of Rainbow™ Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next-generation pulse oximetry.  If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry.  Contact Masimo for more details.

Masimo, Signal Extraction Technology and SET are registered trademarks of Masimo Corporation. Signal Extraction and MasimoU.com are trademarks of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.  Other trademarks are the property of their owners.

Appellate Court Revises Meaning of Last Standing Tyco-Nellcor Patent and Instructs Lower Court to Evaluate Whether or Not There is Infringement In Light of Modified Meaning

Ruling is unrelated to the jury verdict in 2004 where Nellcor was found to infringe several Masimo patents and ordered to pay Masimo over $164 million in damages

Irvine, California, April 12, 2005 - Masimo®, the inventor and leader of read-through motion and low perfusion pulse oximetry, today announced that in a patent appeal of a prior summary judgment motion ruling of non-infringement, the Court of Appeals for the Federal Circuit modified the meaning given to a Nellcor patent by the lower court, and instructed the lower court to reexamine the question of infringement in light of the modified meaning.  The appellate court refused to express any opinion on the issue of infringement.

The patent at issue was asserted by Nellcor against Masimo in 2002.  Masimo filed and the district court granted a summary judgment ruling of non-infringement in 2004.  The patent at issue was unrelated to the jury verdict in 2004 where Nellcor was found to infringe several Masimo patents related to Masimo's read through motion pulse oximeters, and ordered to pay over $164 million in damages.

Nellcor has at one time or another asserted a total of 10 patents against Masimo, nine of which are no longer at issue.  Masimo is confident it will also prevail on this patent, which does not relate to any aspect of Masimo's pulse oximetry technology that impacts performance.

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology® for the non-invasive monitoring of vital signs.  Masimo Signal Extraction™ Technology, or Masimo SET®, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

With the advent of Rainbow™ Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry™.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next-generation pulse oximetry.  If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry.  Contact Masimo for more details.

Masimo, Signal Extraction Technology and SET are registered trademarks of Masimo Corporation. Signal Extraction is a trademark of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.  Other trademarks are the property of their owners.

Masimo Wins Antitrust Lawsuit Against Tyco

Irvine, California, March 23, 2005 - Masimo, the inventor and leader of read-through motion and low perfusion pulse oximetry, today announced that a federal court jury in Los Angeles has found that Tyco Healthcare violated the antitrust laws through anticompetitive business practices specifically related to the sale of its Nellcor pulse oximetry products.  After a four-week trial, the jury found that Tyco had unlawfully maintained monopoly power, and that Tyco's sole-source agreements, bundling of unrelated products, market-share based compliance pricing contracts and co-marketing agreements with original equipment manufacturers were unlawful restraints of trade and exclusionary dealing arrangements.  The jury awarded Masimo $140 million in damages.

Joe E. Kiani, Founder and CEO of Masimo stated, "We sued Tyco to seek relief from Tyco's actions that prevented purchasing decisions from being made based on merits of the products.  We are gratified that the jury found in our favor. Today, my hope is that this verdict will do more than simply open competition in the pulse oximetry market, but also send a strong message that medical product sale and purchases should be based on each individual product's ability to help clinicians improve patient care.  We hope this verdict will benefit patients and our nation's healthcare system by fostering vigorous competition, thereby promoting innovative, cost-effective technologies."

Mr. Kiani continued, "Masimo's mission, since its founding, has been to improve patient care while at the same time reducing cost.  With the advent of Signal Extraction Technology, Masimo raised the performance bar for pulse oximeters.  Not surprisingly, at the small number of hospitals where Tyco's practices did not succeed in excluding Masimo from competing, Masimo's presence also resulted in lower prices for those hospitals."

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  In prestigious medical journals, Masimo SET has been credited for improving the process of care.

With the advent of Rainbow Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo, Signal Extraction Technology, SET and LNOP are registered trademarks of Masimo Corporation. Signal Extraction is a trademark of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.

Masimo Debuts Rad-57, the World's First Monitor Capable of Noninvasively Measuring Carbon Monoxide Levels in the Blood

Irvine, California - March 22, 2005 - Masimo®, the inventor of Read-Through-Motion & Low Perfusion Pulse Oximetry, debuted the Rad-57™ Pulse CO-Oximeter™ at the EMS Today conference in Philadelphia.  The Rad-57 is a handheld monitor that uses advanced signal processing to analyze data from a sophisticated, yet simple-to-apply, finger sensor to accurately measure carboxyhemoglobin (SpCO™), the percentage of blood hemoglobin bound with carbon monoxide.  The SpCO percentage  provides the caregiver continuous measurement of carbon monoxide (CO) in the blood.   In addition, the Rad-57 measures SpO2, pulse rate and perfusion index with Masimo SET technology.

Neil B. Hampson, MD, Medical Director at Virginia Mason Center for Hyperbaric Medicine and Clinical Professor of Medicine at the University of Washington, said: "Carbon monoxide poisoning is very common in the United States.  It has been estimated that over 40,000 cases are diagnosed in emergency departments annually.  This underestimates the magnitude of the problem because clinical suspicion and laboratory blood tests have historically been required to make the diagnosis.  In addition to detecting unsuspected cases of CO exposure, a pulse CO-Oximeter has the potential to shorten the time to treatment of poisoned individuals by allowing first responders to make the diagnosis at the scene."

Dan Allen, EMS Coordinator for Royal Oak Fire Department in Royal Oak, Michigan, had this comment: "We recently had a situation involving a large number of people impacted by CO poisoning at a local indoor swimming pool. Based on the symptoms we transported a number of people to the emergency room for further diagnosis and treatment. A non-invasive device that could measure the amount of CO in a victim would have enabled us to diagnose the more serious cases at the scene, placing them at a higher priority for rapid transport to the hospital. This ability would be of value in any case where CO poisoning needs to be diagnosed or ruled out."

"Evaluating firefighters at emergency sites is important," said Michael Richards, Fire Inspector with the Department of Emergency Services at Rutgers University. "A product like the Rad-57 will be a useful tool in ensuring the safety of our personnel at the scene."

Without the ability to measure carbon monoxide in the blood, it is virtually impossible for firefighters, paramedics, and ER clinicians to determine if a patient has the flu, fatigue, or some level of carbon monoxide (CO) poisoning.  Prior to the Rad-57, the only method to accurately diagnose this type of 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 lead to informed and timely treatment decisions, which should save lives and money. 

The Rad-57 is the first of many products Masimo plans to introduce that employs Masimo Rainbow™ SET technology.  Rainbow technology obtains physiological information from an advanced new sensor technology that employs eight wavelengths.  Prior pulse oximetry technologies, including Masimo's own award-winning SET, utilize sensors with 2 wavelengths. The additional wavelengths provide a rich stream of physiological data, which Masimo's engineering team is using to qualify and develop an array of new life-saving products and applications, beginning with SpCO and the Rad-57. 

Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology® for the non-invasive monitoring of vital signs.  Masimo develops, licenses, and markets advanced medical signal processing technologies and products.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  With its introduction in 1996, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. 

With the advent of Rainbow Technology, Masimo ushers a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry™.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Masimo, Signal Extraction Technology, SET and LNOP are registered trademarks of Masimo Corporation. Signal Extraction, Rad-57 and SpCO are trademarks of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.

Children's Hospital & Research Center at Oakland Completes Conversion to Masimo SET Oximetry

OAKLAND, California.  March 14, 2005.  Children's Hospital & Research Center at Oakland and Masimo®, the inventor of Read-Through-Motion & Low Perfusion Pulse Oximetry, have announced the completion of Children's hospital-wide implementation of Masimo SET® oximetry.  Children's Oakland performed an extensive pulse oximetry comparison and evaluation and cited clinical performance as the chief reason for conversion.

James H. Hanson, MD, Director of Pediatric Intensive Care, said, "In the PICU, we see patients in the worst shape - post-operative cardiac patients, 'shocky' kids, kids with a lot of movement.  Optimizing our care for these kids was the biggest reason we converted to Masimo.  A secondary reason, but a very important one, was how responsive and deeply caring the Masimo people have been about our concerns.  They really listened and responded when we voiced needs.  We definitely felt and continue to feel that they care and are willing to continuously work for us and with us."

Andrew Wen, MD, a pediatric pulmonologist at Children's Oakland who tested Masimo commented, "Masimo gives better and quicker feedback.  Here is an application.  We were testing pulse oximetry in the Exercise Lab during standard procedures.  We had oximeters from Masimo and a competitor.  The patient was dropping sats on Masimo and he looked blue, obviously compromised, but the other oximeter did not drop at all.  Before Masimo, no one knew that oximetry could really be accurate and reliable all the time.  We'd grown accustomed to data failure.  Now, we really have no problems like this at all.  We can deliver quicker and more confident care with Masimo.  It's the best available."

Richard Rowe, MD, Dept. of Anesthesiology, spoke about the reasons for and success of the Masimo conversion from a clinical perspective.  "Masimo was coming into a department that has a lot of history with another provider.  When we were able to test Masimo, however, it just proved to be better technology.  We tested Masimo in the Cardiac Cath lab, in patients with hypoperfusion, and the nurses and docs were both impressed with its performance.  I like to torture new technology by putting it in the absolute worst operative conditions.  The cardiologists placed catheters in both the vein and artery of the patient's left leg.  Normally I wouldn't put a pulse ox on that leg because of poor perfusion but, because we were looking at pulse ox performance, I did it, and it worked just fine.  The PI was fine, the sats were good, the reading was consistent.  It was pretty much bomb proof."  

The evaluation at Children's Hospital of Oakland was extremely thorough and spanned virtually every department.  As a result of the comparative evaluation, Children's Hospital converted hospital wide to Masimo SET a year ago.

 "It is really critical that we have good data all the time from a pulse oximeter," continued Dr. Rowe.  "The hospital is always under a lot of pressure to efficiently evaluate kids for admittance.  Masimo sats have now often become the basis for admittance - it saves us from having to perform extremely time-consuming and expensive tests.  A typical scenario is evaluating a 2-year-old kid with obstructive sleep apnea in the PACU, as the patient wakes up and moves around.  Masimo can robustly tell us if this kid has significant hypoxia and we can admit based upon the reliability of the device.  The other big improvement I've seen is that we do far less babysitting of the pulse oximeter now.  It used to be our standard practice to always have a backup oximeter and multiple probes on tough cases - cardiac surgery, kids with small body mass and poor perfusion. Then, during the case, the data would fail from one of the extremities as the perfusion decreased, so we would have to switch to another extremity.  But Masimo has basically eliminated that problem and we get reliable data even in low perfusion states."

Respiratory therapist Donna Stephenson added, "I had a fortunate experience when we were evaluating Masimo.  I had a cardiac come in, he was blue, obviously struggling, and we couldn't get a sat reading with our other oximeter.  I ran to the shelf and got a Masimo, put it on the patient, and immediately got a reading and could track him back to safe levels.  It's just an anecdote, but ever since then I've had similar experiences and have come to really appreciate the device."

In affirming their decision to convert to Masimo SET oximetry, Children's staff also commented on Masimo's ability to professionally transition the hospital to the Masimo technology, and highlighted some of the unique performance advantages it offers. 

Greg Duncan, AAMI's 2003 Biomed Of the Year and CMIA's Biomed Professional of the Year, co-facilitated the pulse oximetry evaluation at Children's Oakland.  "Clinical preference was really the driving force behind the pulse oximetry product evaluation," said Mr. Duncan.  "We wanted each specialty to give the products a comprehensive review and make their recommendations.  After prescreening by reading some of the available literature, we invited Masimo and our then-current provider to present their technologies.  Once the evaluation was done, we gave a written survey to as broad and as varied a sample of individuals as we could find.  Masimo was clearly the favored technology of that survey, so we went with it."

"When it came time to implement, Masimo's team was effective and efficient," Mr. Duncan continued.  "When issues arose, as they do with major conversions, Masimo was always quick to address the problem.  The in-servicing was great - they were flexible, knowledgeable, they seemed happy to be here, and they really relieved our nurse managers of a lot of scheduling heartache.  I've been very happy with Masimo."

Mary McIlroy, clinical nurse specialist, stated, "I first saw Masimo at a critical care meeting in Montreal a couple years ago and began pushing hard for an evaluation of it here.  When we were finally able to look at it closely, my team trialed Masimo on some of our cardiac patients.  It picked up the most poorly perfused kids we had.  Now that the conversion is up and running, it has really improved our ability to make decisions.  As the nurse specialist, I get all the complaints about pulse oximetry in the Pediatric ICU.  In the months that we've been with Masimo, I have had no complaints at all."

Ann Gomez, Ph.D., RRT, manager of Respiratory Care Services, stated "we have seen a significant improvement in clinical practice tracking inspired oxygen requirements in the premature babies that are at risk for ROP (retinopathy of the premature) in our Neonatal Intensive Care unit.  We are also implementing use of Masimo's new LNOP® 'Blue' sensor for improved saturation monitoring of the neonatal cardiac patient population.  The use of SET technology in PFT and cardiac stress testing, and during transport in ambulances, has made a significant improvement in monitoring through motion. From the business side, we have seen significant cost savings since we have transitioned to SET pulse oximetry."

Joe E. Kiani, CEO of Masimo, stated, "Children's Hospital & Research Center at Oakland has been a particularly re