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 rewarding conversion.  Their standards are high and their requirements are demanding.  It is clearly a hospital that works as a team, mutually respecting and bettering each other toward the goal of world-class care for children.  Along with their continual dedication to providing cutting edge technology, their new bone-marrow transplant facility and sibling donor cord program further demonstrate their passion for delivering the highest level of care to children.  We are proud to partner with Children's Hospital of Oakland."

About Children's Hospital and Research Center of Oakland

Children's Hospital & Research Center at Oakland, founded in 1912, is a pediatric medical center supporting nationally recognized pediatric teaching and research programs. Children's Hospital Oakland has the largest pediatric intensive care unit and the only pediatric emergency department in Northern California.  Children's Hospital & Research Center at Oakland is an extraordinary resource for advanced pediatric care, research, medical education and child advocacy.

About Masimo

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 product.  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 is a trademark of Masimo Corporation.  Rainbow and Pulse CO-Oximetry are trademarks of Masimo Laboratories.

Masimo CEO Joe Kiani Receives SDSU 2005 Monty Award

IRVINE, California - March 7, 2005 - Masimo®, the inventor of Read-Through Motion & Low Perfusion Pulse Oximetry, is proud to announce that its CEO and Founder, Joe E. Kiani, has received the prestigious 2005 Monty award from San Diego State University.  This annual honor recognizes the outstanding achievements and success of prominent SDSU alumni from each of the school's academic colleges, and Mr. Kiani received the College of Engineering 2005 Monty Award.  This year's award ceremonies were held Saturday, March 5th.

Mr. Kiani received both his undergraduate and graduate degrees in electrical engineering from San Diego State University in the 1980's, and founded Masimo in 1989 shortly after completing his formal education.  He has served as CEO and chairman since that time, and co-invented Masimo SET® Pulse Oximetry with friend and engineer, Mohamed Diab, applying system theory and adaptive signal processing to dramatically improve the monitoring of pulse rate and oxygen saturation in the blood.  This month Masimo announced its second major advance in patient monitoring with Masimo Rainbow™ SET Pulse CO-Oximetry™, a new technology that allows caregivers to noninvasively measure carbon monoxide concentration of the blood, for the first time.  The Masimo Rainbow SET platform is designed to allow for the monitoring of additional parameters like methemoglobin (SpMet™), as well as arterial oxygen saturation completely noninvasively.

"When we consider candidates, we look not only for success and innovation, but also for evidence that the university played some role in that success," reported Professor David T. Hayhurst, Dean of Engineering at SDSU.  "Joe Kiani did stellar work here in electrical and computer engineering, and that has clearly been applied brilliantly in the development of Masimo SET Pulse Oximetry, which has gone on to become an international standard.  We are equally impressed with his perseverance in doing what was necessary to overcome numerous significant obstacles in turning his scientific breakthrough into a real product, and then successfully penetrating a market that is very difficult to enter.  We are extremely proud to recognize Joe for all his accomplishments."

"As an educator I persistently address the questions: 'Am I getting through to them? Am I making a difference in their lives? How do I measure if I am?'" says Professor Fredric Harris, Cubic Signal Processing Chair of the Department of Electrical and Computer Engineering at SDSU. "One way is by reviewing the accomplishments of my former students. Joe Kiani is an example of a former student that every teacher wishes he had by the room-full.  Joe is a creative individual who directed his native intelligence and SDSU-acquired education to a class of medical instrumentation problems. He recognized them as an opportunity to apply advanced signal processing techniques. As founder of Masimo Corp., in the best tradition of entrepreneurship, he guided development of a novel class of high performance medical instrumentation methods that have revolutionized patient monitoring systems. The Monty award Joe received at the 33rd Alumni Association Awards Gala is SDSU's public recognition of the success of one our distinguished alumni. His award is much deserved and I am proud to know Joe as a faculty member, as an advisor, and as a friend."

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

Masimo Corporation Announces Masimo Rainbow SET, The World's First Pulse CO-Oximeter

IRVINE, California - March 1, 2005 - Masimo®, the inventor of Read-Through Motion & Low Perfusion Pulse Oximetry, today announced the next breakthrough in the world of noninvasive patient monitoring; Masimo Rainbow™ SET Pulse CO-Oximetry™.  Masimo Rainbow SET employs revolutionary sensor, hardware and software designs that are able to collect more information noninvasively than previously believed possible.  With the introduction of Masimo SET® (Signal Extraction Technology) in 1996, Masimo solved the problem clinicians faced with inaccuracy and false alarms associated with pulse oximetry due to patient motion, low perfusion and other challenging conditions.  Now, with Masimo Rainbow SET, Masimo ushers a new era where carbon monoxide and potentially other vital parameters can be safely and accurately monitored continuously and noninvasively.

Rainbow technology is based on system theory and adaptive signal processing algorithms first introduced to the medical community with Masimo SET in 1996.  Rainbow technology goes further with the ability to analyze information from a sophisticated new sensor technology that employs eight wavelengths.  The Rainbow sensor generates an extraordinarily rich physiological data stream, which opens the door to monitoring additional parameters that presently require costly, inconvenient blood gas measurements that are often unavailable when the information is needed most. 

In addition to Rainbow SET's current ability to noninvasively monitor the level of carbon monoxide in the blood, Masimo's engineering team is utilizing the additional data delivered by the Rainbow technology platform and sensors to qualify and document an array of new potential measurements and applications.   The Masimo Rainbow SET platform has been developed with the intent to deliver accurate monitoring of parameters like methemoglobin (SpMet™), and fractional arterial oxygen saturation (SpaO2™), all measured noninvasively.

The first product built with Rainbow technology, Rad-57™, will be debuted March 19 at the 2005 EMS Today convention in Philadelphia.  The Rad-57 is a handheld Signal Extraction Pulse CO-Oximeter™ that noninvasively measures the percentage of hemoglobin bound with carbon monoxide (SpCO™).  In the past, accurate measurement of carbon monoxide in the body required invasive procedures, and simply was not practical in most emergency situations where it is often needed.  The Rad-57 will provide all clinicians and emergency workers reliable information on carbon monoxide poisoning in seconds, enabling timely decisions on appropriate treatment.  Besides SpCO, the Rad-57 also measures SpO2, perfusion index and pulse rate utilizing Masimo SET pulse oximetry, with its proven ability to read through motion and low perfusion.  Rad-57 utilizes MX-1™, the new Masimo Rainbow SET Pulse CO-Oximetry OEM platform.  Masimo will make MX-1 available to its OEM partners who wish to provide Pulse CO-Oximetry to their customers.

"Ten years ago, Masimo broke new ground by making pulse oximeters more reliable during motion and low perfusion, using their Signal Extraction Technology.   Masimo will advance pulse oximetry again with their new Rainbow technology.  In the 25-year history of pulse oximetry, no one has produced an instrument that will function accurately on patients suffering from carbon monoxide poisoning," reports Dr. Steven Barker, Head of the Department of Anesthesiology at the University of Arizona College of Medicine. "As shown in my studies on animals (Anesthesiology 66:677-79, 1987), conventional pulse oximeters cannot distinguish between oxygenated hemoglobin and carboxyhemoglobin, falsely reporting both as oxygenated. Since carboxyhemoglobin is a toxic form that can cause death at levels greater than 50%, the development of a pulse oximeter that can separately measure carboxyhemoglobin and oxyhemoglobin will be a major advance in healthcare. Such a device would soon become a standard of care in emergency rooms, ambulances, and many other critical care settings."

Joe E. Kiani, CEO of Masimo stated, "Solving unsolvable problems has been the driving force behind Masimo's culture and mission.   Our mission has been to Improve Patient Care and Reduce Cost of Care by Taking Noninvasive Patient Monitoring to New Sites and Applications.  Masimo and Masimo Labs engineering team have been working for years to introduce the Rainbow platform.  Rainbow represents a new era in noninvasive monitoring, and we are eager to deliver these new solutions that we know can save lives and improve outcomes for so many patients.  We are proud to once again introduce the next evolution of pulse oximetry."

Beginning in March, all Masimo Radical pulse oximeters will be shipped "Rainbow Ready".  Rainbow Ready Radical oximeters include Masimo SET technology; and will permit customers to add Rainbow-specific parameters such as SpCO and additional potential parameters via simple software upgrade options.  In addition, Masimo is creating a Rainbow upgrade program to allow its customers who purchased Radicals prior to the availability of this new platform to economically upgrade to Rainbow SET Pulse CO-Oximetry.  Customers should contact their Masimo representative for complete details.  In the months ahead, Masimo will introduce Rainbow SET compatibility in other new products.

About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Pulse CO-Oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products 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 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, Radical and Rad are registered trademarks of Masimo Corporation. Signal Extraction, Rad-57 and MX-1 are trademarks of Masimo Corporation.  Rainbow, Pulse CO-Oximetry, Pulse CO-Oximeter, SpCO, SpMet, and SpaO2 are trademarks of Masimo Laboratories.

Masimo announces the passing of board member, advisor and long-time friend Dr. H.J.C. Swan

IRVINE, California - February 10, 2005 - Masimo regrets to announce the passing of one of its founding board members and original advisors, Dr. H.J.C. Swan on February 7, 2005. Chairman emeritus at Cedar-Sinai Medical Center's Division of Cardiology, Dr. Swan led the department from 1965 to 1987.  Dr. Swan was also a past president of the American College of Cardiology, and was the 1985 recipient of the James Herrick Award of the American Heart Association. In 1968, with colleague William Ganz, M.D., Swan introduced the Swan-Ganz heart catheter into clinical use, triggering a new era in treatment of critically ill patients. 

Dr. Swan became an advisor to Masimo shortly after its founding in 1989, and soon provided valuable insight and leadership as Chairman of Masimo's Scientific Advisory Board.  In August 1992 Dr. Swan became a member of Masimo's Board of Directors, a position in which he served diligently until his passing. Dr. Swan's passion for science and patient care guided Masimo and from Masimo's humble beginnings, provided it with credibility in the patient care community. 

Joe E. Kiani, CEO of Masimo, stated, "Dr. Swan has been a tremendous mentor, and a close friend to me personally.  When Masimo was no more than two young engineers in a garage, Dr. Swan generously gave his time, and moral support to keep us on the road he knew we should stay on. When we were unraveling the mysteries of physiological signals and noise, Dr. Swan's mastery of human physiology helped us along the way.  But more importantly, Dr. Swan was dedicated to the highest standards and ethics, which helped guide us through this journey. We will profoundly miss him and be less without him."

"Dr. Swan was neither Masimo's, nor any other institution's person.  Dr. Swan belonged to all people and made his contribution for all people.  With his invention of the Swan-Ganz Catheter he ushered not only a new era of care, but triggered many other developments that have helped mankind.  It's wonderful for us all to have lived in a time that Dr. Swan lived," continued Joe Kiani.

Memorial services to celebrate the life of Dr. Jeremy Swan will be held Friday, February 18, 2005 11am at:

Hollywood Presbyterian Church
1760 N. Gower
Hollywood, CA

In lieu of flowers, contributions may be made to:

"H.J.C. Swan Memorial Heart Fund" dedicated to supporting heart research
Division of Cardiology at Cedar-Sinai Medical Center
Room 5347
8700 Beverly Blvd.
Los Angeles, CA  90048

Or: 
    
The Swan Fund for Teaching in Medical Ethics
Trinity Foundation
Trinity College
Dublin, 2
Ireland

Masimo Places in MIT Technology Review "Patent Scorecard" Top 50 for Technological Strength

IRVINE, California - February 7, 2005 - Masimo, the inventor of Read-Through Motion & Low Perfusion Pulse Oximetry, has been ranked 49th in the world, amongst computing technology companies, for technological strength based on its patent portfolio and engineering capabilities.

The report, published in the M.I.T. Technology Review, ranks companies in many industries, from automotive to high tech, and covers data collected through 2003.  Masimo has been evaluated in the highly competitive "Computer" category due to the use of systems theory, adaptive signal processing and intelligent software algorithms in accomplishing its technological leadership.  Masimo's 2003 position placed it ahead of such internationally recognized leaders as Acer, Adobe, Computer Associates and Cray and behind companies like IBM, HP, Microsoft, and Cisco.  Final position on the Technology Review Scorecard is based on an evaluation "which gives an overall assessment of a company's intellectual-property power," and is not based solely on number of patents filed or received. 

Masimo has enjoyed a presence on this list for a number of years, with an average ranking of 82 from 1998 through 2002.  However, Masimo made a big jump to number 49 in 2003 with the introduction of new products and a series of new patents. Many of Masimo's patents are based on developments in system theory and adaptive signal processing (filtering).  System theory is an advanced form of mathematics that can be used to identify and isolate specific signals amidst noise, while adaptive filtering is employed to remove undesired and unpredictable in-band noise, leaving primarily the desired signal.  Masimo has pioneered this area for the medical devices world, and much of its current technological strength is owed to these areas of science.

This recognition arrives almost simultaneously with an article in the January/February 2005 issue of MX magazine. This story explains why the use of system theory and adaptive signal processing can accomplish breakthroughs in patient care, and highlights Masimo SET technology as one of the premier medical solutions, and the first in Pulse Oximetry, developed using these advanced approaches. The author, Gail Baura, has also written an IEEE book titled System Theory and Practical Applications of Biomedical Signals that covers this topic, and Masimo's contributions to the field, in exceptional detail.

Joe E. Kiani, CEO of Masimo, stated, "When we developed the world's first vital signs monitor with system theory and adaptive signal processing, we were confident that we were ushering in a new era of patient care.  We have worked very hard to advance noninvasive patient monitoring, and it is gratifying to be recognized for our ongoing technological leadership.  We are committed to continuing this work in our efforts to improve the effectiveness of sophisticated medical equipment for the ultimate goal of improving patient outcomes."

Masimo, founded in 1989, is the innovator and leader of read-through-motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  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.

The Scorecard story and rankings are found at: www.technologyreview.com/scorecards/

The MX story is found at: www.devicelink.com/mx/archive/05/01/baura.html

Masimo Announces LNCS & LNOPv Sensors Expanding Clinician Choice

IRVINE, California - January 25, 2005 - Masimo, the inventor of Read-Through Motion & Low Perfusion Pulse Oximetry, today announced the dramatic expansion of Masimo's sensor offering with the introduction of LNCS and LNOPv sensor series.  With LNCS and LNOPv, Masimo's customers will have access to well over 40 adhesive, reusable, Resposable™ and specialty sensors-including the LNOP Blue sensor designed for cyanotic babies; giving Masimo's customers nearly twice the number of sensors to choose from than the nearest competitor.  Both LNCS and LNOPv have Masimo's revolutionary recessed photo-detector design which maximizes the differentiation between signal and noise, first introduced with the launch of Masimo LNOP sensors.  

LNCS, or Low Noise Cabled Sensors, are uniquely designed cabled sensors, which offer the best pulse oximetry performance for a sensor with integral cable.  LNCS is intended for hospitals that prefer to minimize clinician-user-interface change when upgrading their pulse oximetry to Masimo SET. 

LNOPv is a "value" line sensor based on industry standard setting Masimo LNOP "flex circuit" tape design.  LNOPv adhesive sensors are ideal for short term continuous pulse oximetry monitoring, and provide the lowest price entry point for Masimo SET pulse oximetry.  LNOPv sensors are designed to last as long as competing sensors, but will not last as long as Masimo's LNOP sensors.

LNOP sensors, which were first introduced by Masimo in 1995, have since set the standard for performance, durability, and been the choice sensor for "Green"-conscience users.  Masimo focused its sensor engineering on flex circuit sensors because they allow for the most flexible adhesive surface, lightest weight, (often important for neonates' normal development), and the lowest noise, which ultimately allow for precise measurement.  Over 70 independent and objective clinical studies have shown that Masimo SET with LNOP sensors has solved the problems of motion and low perfusion and is the Gold Standard in pulse oximetry. 

Masimo has invested years in creating Low Noise Cable (LNC™) technology, the ideal cable for the pulse oximetry environment.  LNC provides the highest performance of any integrated pulse oximetry sensor cable and yet is flexible, and can be manufactured affordably enough for use in a disposable sensor.  LNCS sensors using LNC cable technology offer nearly the same performance as the LNOP flex-circuit design.  The LNOP single patient sensor line is still the industry "gold standard", while LNCS is the best cabled sensor alternative.  LNCS sensors will work with all Masimo SET pulse oximeters, but are also designed to operate on Nellcor sensor compatible instruments without Oximax.

Joe E. Kiani, CEO of Masimo, stated, "Ten years ago, Masimo ushered in a new era for patient monitoring with read-through motion and low perfusion pulse oximetry with the launch of Masimo SET with LNOP sensors.  We are proud to offer clinicians with more choice with the introduction of LNCS and LNOPv sensor series.   Providing a well-shielded disposable cable that met the Masimo standards was a significant challenge, but today our engineers have answered this challenge with LNCS."

Masimo, founded in 1989, is the innovator and leader of read-through-motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  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.

For more information on LNCS sensors, visit: www.masimo.com/sensors/lncs.htm

For more information on LNOPv sensors: visit: www.masimo.com/sensors/lnopv.htm

Spacelabs Medical and Masimo Announce Pulse Oximetry Technology Alliance

Issaquah, WA, January 10, 2005 - Spacelabs Medical, a global manufacturer and distributor of patient monitoring systems, and Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, today announced an alliance whereby Masimo SET (Signal Extraction Technology) will be integrated and offered in Spacelabs patient monitoring equipment.  Masimo SET is a fundamentally distinct method of measuring oxygen saturation of the blood and is known for its standard-setting ability to read through challenging conditions of patient motion and low perfusion.

This alliance will enable Spacelabs Medical to incorporate Masimo's gold standard SET Pulse Oximetry into Spacelabs Medical patient monitoring systems, including Spacelabs UltraviewSL bedside monitors.

Dave Tilley, President and COO of Spacelabs Medical, stated, "Our goal is to partner with forward-looking technology partners and Masimo is a great example.  Our 'Customer First' commitment means providing technologies that can make a positive difference in patient care.  By delivering high performance and minimizing false alarms, Masimo SET Pulse Oximetry is a great example of such a technology."

Joe E. Kiani, CEO of Masimo Corporation, added,  "We are happy to partner with Spacelabs to create patient monitoring solutions that combine the strengths of both companies to best meet the needs of clinicians and the patients they treat in health care institutions around the world." 

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 innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

Happy Holidays from Masimo!

This has been an exciting and successful year for Masimo and we wish to share our success with charitable organizations by making a donation on your behalf. As we continue with our mission to solve unsolvable problems that will improve patient care, we would like to thank those of you who encourage and improve us with your collaboration and high standards.

For many years, we have conducted business in accordance with our Guiding Principles, and in 2004 we added the fifth principle: Do What is Best For Patient Care.  This is the most important objective of healthcare practitioners, and today it consciously guides every decision we make.  In 2004, we demonstrated our commitment to this principle by developing the Blue Sensor, optimized for a very small but important population of cyanotic infants.

As a show of gratitude to those of you who have supported the cause for better care, and to fulfill our heart-felt responsibility to give something back to our world community, Masimo would like to donate $5 to a charity of your choice.  We have carefully selected the following organizations committed to better care and a better world, and we will make a contribution on behalf of each person who is an official member of Livewire as of today, and who responds to this Livewire with their choice from the list below:

Please send us e-mail at: charity@masimo.com to specify your selection.  Only requests by e-mail will be processed.  We also would appreciate comments and suggestions from you on our mission and guiding principles, which are listed below, or any other suggestions you may have. 

Masimo's Mission is to improve patient outcome and reduce cost of care by making noninvasive monitoring effective and reliable and taking noninvasive monitoring to new sites and applications.

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

Medtronic LIFEPAK 12 Defibrillator/Monitor Adds Masimo Signal Extraction Technology for Pulse Oximetry

IRVINE, Calif. and REDMOND, Wash., December 6, 2004 — Masimo Corporation, the innovator and leader of Signal Extraction Pulse Oximetry, and Medtronic, the world's leading medical technology company, today announced that Masimo SET® pulse oximetry technology is now available in LIFEPAK® 12 defibrillator/monitors.

Pulse oximetry continuously tracks pulse rate and oxygen saturation in the blood to determine trends and warn of decreasing saturation levels.  The LIFEPAK 12 defibrillator/monitor is used in both mobile emergency medical services and hospital settings.  Medtronic's LIFEPAK 20 defibrillator/monitor, which is used mostly in hospital and clinic settings, has included Masimo SET Pulse Oximetry technology since 2002.

"We design and build our products with an eye to the needs of both the users and the patients," said Robert White, president of Medtronic's Emergency Response Systems business unit.  "Masimo SET technology has been a successful component of the LIFEPAK 20 and the inclusion of this technology in the LIFEPAK 12 will be very beneficial to the overall management of emergency patient care."

Joe E. Kiani, CEO of Masimo, stated, "We are proud to be working with Medtronic to help emergency care providers revive patients.  We have always respected Medtronic's commitment to patient care, and we are pleased to be represented as the pulse oximetry technology of choice in Medtronic's products."

About Masimo
Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  Masimo is headquartered in Irvine, California.  Additional information about Masimo and its products can be found at www.masimo.com.

About Medtronic
Medtronic's Emergency Response Systems business unit, located in Redmond, Wash., pioneered defibrillation technology nearly 50 years ago. With 475,000 LIFEPAK defibrillators distributed worldwide, it is the world's leading provider of external defibrillators for the treatment of sudden cardiac arrest. For more information on LIFEPAK defibrillator/monitors, visit www.medtronic-ers.com or call 1-800-442-1142.   Medtronic, Inc. (NYSE: MDT), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.  For more information about Medtronic, visit www.medtronic.com or call 1-800-328-2518.

Masimo Announces Support for the Medical Device Competition Act of 2004, Designed to Enhance Clinicians' Choice in the Care They Provide Their Patients

November 10, 2004 - IRVINE, California - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced its support of the "Medical Device Competition Act of 2004," which seeks to promote greater competition within the medical technology industry and enhance the freedom of  clinicians to choose the care they believe is best for their patients.  In addition, this bill aims to increase competition, the improvement of products made available for patient care, and make available competitive pricing for hospitals. The bill was introduced last month by United States Senators Herb Kohl (D - Wisconsin) and Mike DeWine (R - Ohio), Ranking Member and Chairman of the Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights. 

Almost every product purchased by most hospitals is acquired through contracts with group purchasing organizations (GPOs).  Hospitals join GPOs with the expectation of paying lower prices for the products they purchase.  GPOs are funded by fees paid by manufacturers and distributors, based upon the sales volume of products purchased through each GPO contract.  For the last three years, the Subcommittee has been investigating the GPO industry.  As a result of that investigation and other actions that have spotlighted questionable industry practices, HIGPA, the GPO's trade association, adopted a baseline code of conduct and six of the nation's leading GPOs enacted voluntary codes of conduct to address anticompetitive and unethical business practices.

In the past ten years, hospital purchasing power has been largely in the hands of GPOs and not in the hands of clinicians who are most aware of what technologies will best help their patients.  The cost savings promised by GPOs as a trade-off for limiting product choices is not always realized, however.  Two studies done by the Government Accountability Office, upon request of the Subcommittee, showed that 1) purchasing with GPO contracts did not ensure that hospitals saved money, and 2) GPOs, which control over 95% of hospital purchases, have adopted codes of conduct that are not uniform and some cases include exceptions and qualified language that effectively nullify their potential to affect the changes necessary to promote technological innovation and free and open competition. Click here to view GAO report 2002, GAO report 2003

In order to assist the GPO industry to make meaningful changes in their business practices, Senators DeWine and Kohl introduced the Medical Device Competition Act of 2004, on September 28, 2004, after the third Subcommittee Hearing on GPO business practices.  In their press release announcing the bill, Senators Kohl and DeWine stated, "Our goal is to ensure that physicians and patients have access to the highest quality medical products at the lowest prices, and to prevent improper barriers to competition among hospital suppliers. We also want to ensure that GPOs fulfill their important purpose - to cut prices for thousands of hospitals across the country and thereby restrain health care costs. We believe our bill strikes the right balance and accomplishes these goals. It will ensure that the considerable reforms we have already achieved in the hospital purchasing industry will not be lost should our scrutiny of this industry be lessened."

"Our bill will ensure that GPOs act in the best interests of patients and hospitals. Giving the Department of Health and Human Services oversight of this industry will help prevent improper practices that can endanger patients' access to the best and safest products," added Senator Kohl.

Senator DeWine, the Chairman of the Subcommittee, stated, "We have come a long way with the GPO industry. Through many discussions and hard work on the voluntary codes, manufacturers, hospitals, doctors and other healthcare workers, and most importantly patients, are all better off. This bill is another step in the process and I look forward to working with all the interested parties to assure that we continue to progress towards better, safer and less expensive healthcare."

Joe E. Kiani, founder and CEO of Masimo, stated, "GPOs were granted special exemptions from anti-kickback laws by Congress in an effort to help hospitals negotiate lower prices. The Medical Device Act of 2004 is necessary to help ensure that GPOs use this advantage to benefit hospitals and the patients they care for."  Mr. Kiani continued, "When we introduced a breakthrough technology to the market and found that most hospitals could not purchase it due to GPO contracts even though our product was based on superior technology and offered a lower price, we knew something was wrong.  Fortunately, the New York Times took up the investigation and did much to expose a practice that ultimately hurt patients because it impeded clinicians' access to lifesaving technology.  However, the bipartisan efforts of Senator Kohl and Senator DeWine brought hope for those who truly want to help patients.  Last month, after three hearings and over three years of investigation, Senators Kohl and DeWine introduced this legislation.  This bill, if passed, should result in increased competition, which in turn will result in better products available to hospitals at competitive prices.  We thank the Subcommittee and especially Senators Kohl and DeWine for their courageous efforts to improve our nation's healthcare."

To learn more about the Senate Hearings and the Medical Device Act of 2004 Bill, click here.

Research Presented at the 2004 American Society of Anesthesiologists Conference Finds New Uses for Masimo SET Perfusion Index and Validates the Clinical Value of Masimo SET TC-I Ear Sensor

LAS VEGAS, Nevada - October 27, 2004 - Research presented at the 2004 American Society of Anesthesiologists (ASA) conference in Las Vegas, NV, October 24-26, included two studies on new clinical applications of Masimo SET perfusion index and in another study hailed the clinical value of the Masimo SET TC-I Ear sensor.  Also at the conference, three separate studies continued to show poor performance with forehead pulse oximetry sensors and cautioned clinicians attempting to use them clinically.

The Value of Perfusion Index
The Masimo SET Perfusion Index (PI) is a relative assessment of the perfusion at the monitoring site.  Various researchers have found that the Masimo SET PI may be diagnostically useful in assessing patient well-being, in therapeutic efforts, and in indicating pain stimuli during anesthesia. 

Mitchell Goldstein, M.D., FAAP, and a team of researchers from Citrus Valley Medical Center in West Covina, CA, tested the Masimo SET Perfusion Index's diagnostic applicability on neonates with respect to the Neonatal Therapeutic Intervention Scoring System (NTISS). The researchers found that there is a statistically significant difference in PI between patients in the NTISS-identified "sick" and "well" groups. Dr. Goldstein stated, "It appears that PI can provide a useful independent measure of sickness and well-being, and it may be an important adjunct to the ASA system of assessment of perioperative morbidities."1

Dr. Helmut Hager from Washington University, St. Louis, Missouri, used the Masimo SET PI functionality on anesthetized volunteers during the application of painful stimuli.  Dr. Hager found that the PI declined significantly from its baseline level during pain stimuli.  He also noted a weak correlation between endtidal Sevoflurane concentration and perfusion index.  Based on this evidence, Dr. Hager concluded, "The perfusion index is able to independently indicate a noxious stimulus in anesthetized volunteers in different concentrations of Sevoflurane.  Thus it may be of clinical value to assess pain."2 

TC-I Ear Sensor Hailed
Daniel Redford, M.D., and other researchers from the Department of Anesthesiology, University of Arizona at Tucson, compared the Nellcor Max-Fast forehead sensor to the Masimo SET LNOP   TC-I earlobe sensor.3   Their data showed that the TC-I sensor performed significantly better than the Max-Fast sensor.  Dr. Redford stated, "Masimo SET technology and the advent of the TipClip sensor has totally changed the way I practice anesthesiology, especially in pediatrics.  It is the most accurate and reliable sensor I've used.  I carry one in my pocket.  On congenital heart patients, I usually use three pulse oximeters with sensors on preductal, postductal, and a central site with a TipClip sensor." 

Dr. Redford continued, "For those accustomed to Nellcor, they need to compare it side-by-side with Masimo to get a feel for the difference.  It is not appropriate to conclude which technology is better when you haven't tried both.  Masimo has even offered a $250,000 guarantee that they will win any side-by-side clinical evaluation."

Limitation of Forehead Sensors
In a separate study, Dr. Helmut Hager used the Nellcor Max-Fast sensor on surgical patients.4   Dr. Hager said, "We discovered the limitations of the forehead sensor during routine lung surgery, not when we were trying to see if we could throw it off.  We simply had a patient turned on his right side because we were operating on his left lung, so we had the forehead sensor on the right side of the forehead, which is standard practice.  We also had a headband on, which has been said to help the sensor read.  But the sensor just would not work - it kept losing readings.  The only time we could get a reading is after we had expelled pooled venous blood by applying much pressure with our fingers; once we relieved the pressure, we could get a reading until the venous blood had time to pool again.  And what we found is that this error is completely reproducible.  Every time the sensor was placed on the dependent side during surgery, the sensor would drop out.  There is more work to be done on these sensors before they will be really useful in surgery."

In a second study, Dr. Redford showed significant performance and reliability differences between the Masimo TF-I forehead sensor and the Nellcor Max-Fast forehead sensor in the Operating Room.5   The Masimo forehead TransFlectance sensor, with a Performance Index of 99.4%, performed significantly better than the Nellcor Max-Fast forehead sensor, which generated a performance index of 79.8%.  Dr. Redford said, "Because the Nellcor Max-Fast sensor had significantly longer periods of time where the SpO2 reading was falsely low, it is unacceptable for use in the pediatric surgical patient.  In contrast, the superior performance of the Masimo Radical TF-I forehead sensor produced superior results, evidenced by a small bias and precision."

Aman Mahajan, M.D., and a team of researchers from the Department of Anesthesiology at UCLA School of Medicine, reported poor performance with the Max-Fast sensor in a population of adult surgical patients.  Dr. Mahajan concluded, "This study demonstrates poor performance of the forehead reflectance pulse oximeter.  In our patients, the Max-Fast sensor attached to the N595 oximeter demonstrated an unacceptable bias and precision was in error by more than 5% for more than 20% of the total operative time in eleven (55%) of the cases studied.  This forehead sensor is not accurate or reliable enough for clinical use in pediatric surgical patients."6

About Masimo
Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  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.



1 Goldstein MR, Sindel BD, Furman GI, Ochikubo CG, Martin GI.  Perfusion index (PI) correlates with the neonatal therapeutic intervention scoring system (NTISS) as an indication of clinical well-being.  Poster A-1430, 2004 ASA, Las Vegas, NV.
2 Hager H, Church S, Mandadi G, Pulley D, Kurz A.  The Perfusion Index Measured by a Pulse Oximeter Indicates Pain Stimuli in Anesthetized Volunteers.  Poster A-514, 2004 ASA, Las Vegas, NV.
3 Redford D, Lichtenthal P, Barker S.  An Intraoperative Comparison of Ear Transmission and Forehead Reflectance Oximetry in Pediatric Surgical Patients.  Poster A-579, 2004 ASA, Las Vegas, NV.
4 Hager H, Mandadi G, Reddy D, Pulley D, Kurz A.  Clinical Experiences with a New Forehead Reflectance Pulse Oximetry Sensor in ASA II Patients During Surgery.  Poster A-564, 2004 ASA, Las Vegas, NV.
5 Redford D, Lichtenthal P, Barker S. Evaluation of 2 Forehead Reflectance Oximeters in Pediatric Intraoperative Surgical Patients, Poster A-593, 2004 ASA, Las Vegas, NV.
6 Mahajan A, Lee E, Moldovan A.  Intraoperative Use of Forehead Reflectance Oximetry in Pediatric Patients.  Poster A-590, 2004 ASA, Las Vegas, NV.

Masimo SET Reaches 200,000th Shipment

IRVINE, California - October 14, 2004 - Masimo, the innovator and leader of read-through motion and low perfusion pulse oximetry, today announced that it has shipped its 200,000th Masimo Signal Extraction Technology pulse oximeter. 

Since the initial commercial launch of Masimo SET (Signal Extraction Technology), read-through motion and low perfusion oximetry has become the standard of care in pulse oximetry.   Prominent hospitals and health care centers worldwide have converted to Masimo SET, including Brigham and Women's, Johns Hopkins, UCLA, Hospital for Sick Children in Toronto, National Children's Hospital in Tokyo, Nippon Medical School in Tokyo, Assistance Publique de Paris, Leeds Health Authority in the UK, and Auckland City Hospital in New Zealand.

Before Masimo SET, pulse oximetry worked only when patient conditions were just right - motionless patients with strong pulses, and good perfusion.  Today, Masimo SET pulse oximetry has been demonstrated in over 100 clinical studies to be a dramatic improvement in arterial blood oxygen and pulse rate monitoring and has been shown to contribute to improved patient outcomes.  It has also become a key component in international protocols studying the prevention of Retinopathy of Prematurity (ROP), the infant eye disease that causes blindness in 2000 babies a year.  As an added benefit to these performance improvements, Masimo SET has been shown to reduce overall expenditures. 

Masimo SET has also ushered in a host of potential new applications for pulse oximetry, such as being diagnostically useful in predicting illness severity in neonates, detecting hypoplastic left heart syndrome, tracking and guiding resuscitative efforts, detecting changes in perfusion brought on by anesthetic agents and pain, and even being used to close the loop on ventilation and drug delivery.  New applications for this robust technology are continually being discovered.

Joe E. Kiani, founder and CEO of Masimo, said, "Masimo's mission since inception has been to 'improve patient care and reduce cost of care by taking noninvasive monitoring to new sites and applications.'  This mission drove the creation of Signal Extraction Technology and it still drives every step we take in terms of product development, customer service, community service and business strategy.  We are happy that despite numerous obstacles and challenges, over 200,000 Masimo SET pulse oximeters are now improving patient care around the world.  We could have not accomplished this without the support of leading clinicians and patient monitoring companies around the globe as well as the oversight of members of the US Senate in US Group Purchasing Practices."

About Masimo
Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  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 Will Introduce Two New Specialty Sensors at the NANN Conference: The Blue Cyanotic Sensor and the Hi-Fi Trauma Sensor

IRVINE, California - October 6, 2004 - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced that it will debut two breakthrough Low Noise Optical Probe Specialty sensors at the NANN conference on October 13 in Orlando, Florida.   The new LNOP Specialty sensors were designed to give clinicians maximum accuracy and reliability in difficult-to-monitor pediatric and neonatal situations, particularly in applications involving emergency, trauma, and newborn delivery & resuscitation monitoring.  The development of these highly specialized sensors is part of Masimo's mission to ensure all patients are monitored accurately for optimal patient care.

The Masimo LNOP Blue Sensor is designed for cyanotic babies and children with congenital heart defects.  Cyanotic babies' oxygen saturation is usually around 60% to 80% vs. the normal 90% to 95%.  Pulse oximeters in the past have had poor accuracy and precision in this patient population.  The LNOP Blue sensor has been designed to improve the accuracy in monitoring cyanotic patients. The LNOP Blue sensor is easily identified by a blue connector.

The Masimo LNOP Hi-Fi Trauma sensor was designed specifically for trauma situations, including accurate tracking through newborn resuscitation.  To improve clinicians' efficiency in extreme situations, the LNOP Hi-Fi sensors automatically reconfigure Masimo SET oximeters to fastest-response and highest sensitivity modes, so clinicians don't have to spend precious seconds reconfiguring the oximeter.  In addition, a unique combination of adhesive and cloth with Velcro secures the sensor to the patient even when the site is wet.  The LNOP Hi-Fi sensor is easily identified by a yellow connector.

Peter Cox, MD, Clinical Director, Pediatric Intensive Care Unit, Hospital for Sick Children in Toronto, Canada stated, "We have been testing this new Blue sensor for several 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, 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 have recently 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."

Mitchell Goldstein, MD, Dept. of Neonatology, Queen of the Valley Hospital in West Covina, California, stated, "Time is crucial when infants are struggling for life. The Hi-Fi sensor helps clinicians maximize the time we can spend caring for patients.  During newborn resuscitation, frequently nothing works.  With Masimo, we have been able to successfully track newborn resuscitation." 

Joe E. Kiani, founder & CEO of Masimo, said, "We have been able to design these sensors for very specific and challenging patient conditions by working with caring clinicians.  We felt it was a shared responsibility to develop these new sensors for the care of these patients.  Attention to the most challenging conditions where pulse oximetry can make a real difference is what Masimo is all about."

About Masimo
Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs.  Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters.  Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.  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.