Researchers From Columbia University Show Masimo SET Oximetry Performs Much More Reliably Than Conventional Oximetry

Masimo is shown to have superior ability to read through conditions of active sleep and excessive motion during and after circumcision

IRVINE, California. December 19, 2003. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry, today announced a new publication on the performance of Masimo on neonates during challenging clinical motion. The study, published in the Archives of Diseases in Child, Fetal, and Neonatal Education (2003;88:F505-F508), was conducted by Drs. R. Sahni, A.Gupta, K Ohira-Kist, and T S Rosen at the Department of Pediatrics, Columbia University Hospital. Healthy term neonates were monitored with pulse oximetry immediately before, during, and after, circumcision procedures. The researchers compared data reliability and availability provided by Tyco-Nellcor N-200 and Masimo SET V2 pulse oximetry technologies, as well as heart rate measured by ECG. The researchers reported that Masimo SET had at least two to five times less artifact and in some conditions more than 50 times less artifact. The researchers concluded that, due to artifact caused by motion, the Nellcor oximetry was vulnerable, while the Masimo technology, due to superior signal acquisition capabilities, resulted in far fewer false alarms and provided continuous accurate monitoring through even the most extreme motions.

The researchers reported, "Our data suggests that the Masimo signal extraction pulse oximetry performance may improve pulse oximetry performance particularly in clinical situations in which extreme motion is likely, such as circumcision and crying in neonates." The superior technological difference shown by the Masimo pulse oximeter during the entire study also led these researchers to suggest, "A more accurate and reliable pulse oximeter should have the capacity to refine the therapeutic use of oxygen and benefit patient management and outcome."

Mike Petterson, Sr. Director of Clinical Research, Masimo, commented, "Masimo SET has been the subject of much favorable research. We are pleased to see Dr. Sahni's research corroborates others' findings that, by eliminating the problems of motion artifact and low perfusion, Masimo has turned pulse oximetry into a clinically useful tool."

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on www.masimo.com.

Dr. Augusto Sola, Lead Researcher and Author of a Breakthrough Protocol to Reduce ROP, Presents to Respiratory Therapists on the Future of ROP

LAS VEGAS, Nevada. December 11, 2003. Augusto Sola, M.D., senior researcher in a 5-year study aimed at reducing the rate of ROP (or infant eye damage) through the use of a groundbreaking neonatal oxygenation protocol, addressed respiratory clinicians at the 2003 American Association of Respiratory Care congress in Las Vegas, Nevada. Dr. Sola's protocol, implemented and tested at Cedars-Sinai Medical Center in Los Angeles, reduced the rate of ROP at Cedars-Sinai from about 12% to 2.5% and the need for ROP laser treatment decreased from 4.5% to 0% in the last three years of the study1. His protocol was developed based on the belief that rapid swings in oxygenation or hyperoxygenation of the infant results in ROP. Relieving this epidemic, according to Dr. Sola, requires clinicians to close the gap between knowledge and practice. Tuesday night's lecture, "ROP and Oxygen: A Changing Relationship," was delivered to a crowded room of over 200 respiratory therapists.

Dr. Sola paid close attention to the clinical interests of his audience and his lecture was partly cautionary. Among his chief objectives was to implore clinicians to avoid oxygen fluctuations, hyperoxia, and the use, from the time of birth, of monitoring devices prone to false alarms or to holding values during motion and low perfusion. He cautioned many times that, "What we see is sometimes less important than what we don't see. Oxygen, for example, can be a dangerous drug and strict attention to its use is essential." In order to ensure that oxygen levels are tightly maintained within the boundaries prescribed, Dr. Sola spoke of the importance of the accuracy and reliability of Masimo SET technology as a key component to his protocol. He further claimed that the reduced false alarms of Masimo SET led to vastly decreased fluctuations in FiO2 administrations as caregivers became more confident in the readings. Because of those performance benefits and the fact that Masimo SET will not drop out or freeze values at critical times, Dr. Sola said Masimo SET played an inextricable role in their ability to dramatically reduce ROP.

Dr. Sola said, "The gap between knowledge and practice can lead to morbidity and can even be lethal. It is estimated that 2000 babies every year are blinded in the USA because of ROP. Let's put this another way - if the average life expectancy for this fragile babies were 70 years after discharge from the NICU, 70 years x 2,000 babies = 140,000 years of blinded life entering society every year. If we understand that, from birth, slow weaning of oxygen within acceptable lower oxygen saturation ranges is safe, and if we understand how to recognize grades of severity of ROP, and if we can understand the basic differences in the technology of oxygen monitoring, we can markedly decrease the number of infants who survive with the most severe forms of this disease." Dr. Sola continued, "I tell my friends, my family, and my neighbors in America and overseas, a good thing happened in 1989 - Masimo SET technology changed the way we can use pulse oximetry."

Joe E. Kiani, CEO of Masimo Corporation, said, "Dr. Sola may have done for ROP victims what Dr. Jonas Salk did for polio victims. His findings are that significant. It is one thing to look at numbers on the paper, it is another to see an infant that couldn't recognize his mother or see a sunset if it wasn't for Dr. Sola and his colleagues breakthrough research. Dr. Sola spoke passionately- I think all who attended his lecture left with a sense that the elimination of ROP and the profound increase in the quality of life of thousands of babies each year, is within our grasp."

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on www.masimo.com.

Masimo & Linde Medical Sensors Form Alliance to Provide Combined Arterial Blood Oxygen and Carbon Dioxide Sensor & Monitor

BASEL, Switzerland. December 3, 2003. Linde Medical Sensors AG and Masimo today announced two long-term agreements to provide combined arterial oxygen and carbon dioxide sensors and monitors worldwide. A purchasing and licensing agreement will make Masimo SET^® the sole SpO2 monitoring technology of TOSCA^™, and an exclusive distribution agreement makes Masimo the sole distributor of TOSCA in the US. TOSCA provides continuous monitoring of transcutaneous PCO2, SpO2 and Pulse Rate through a single heated sensor. With Masimo SET technology, TOSCA delivers accurate SpO2 readings in conditions of motion, poor perfusion, and other low signal to noise conditions.

Steffen Klose, CEO of Linde Medical Sensors AG, said, "Masimo is the standard for SpO2 monitoring. Their pursuit of pulse oximetry perfection matches our pursuit of excellence in transcutaneous blood gas monitoring. The union in TOSCA offers clinicians an unparalleled, comprehensive picture of the patient's oxygenation and ventilation status. It is an honor for us to partner with Masimo."

Joe E. Kiani, CEO of Masimo, stated, "Many patients are at risk of high levels of carbon dioxide, even though their oxygen saturation seems normal and stable. There hasn't been a simple easy to use device that can monitor both blood oxygen and carbon dioxide, especially for non-intubated patients. TOSCA, the easy to use transcutaneous PCO2 and SpO2 monitor, should help clinicians provide the best care possible for such patients. We are proud to be able to work with the Linde Medical Sensors team to provide this solution to our customers."

About Linde Medical Sensors AG

Linde Medical Sensors AG was originally a department of F. Hoffman-La Roche named Bio-Electronics which was founded in 1969. Its activities were devoted to research, development, and manufacturing of medical devices. One of the first results was the invention of methodology of transcutaneous blood gas measurement. This allowed for the first time the routine monitoring of the most important blood gases - oxygen and carbon dioxide - in a very easy way and without taking blood samples. This invention was a significant breakthrough for which Roche Bio-Electronics received the basic general patent. Furthermore this method led the way to new diagnostic and therapeutic opportunities in various fields in medicine, especially in neonatology. The products were distributed through the sales organization of Kontron (a part of Hoffman-La Roche, at that time). In 1992, the group was integrated as the division "Medical Sensors" into Kontron Instruments. In March 1999, the division Medical Sensors was taken over by Linde AG, Germany, and the LINDE MEDICAL SENSORS AG was established. Additional information about Linde Medical Sensors and its products can be found at www.Linde-ms.ch

About Masimo Corporation

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at www.masimo.com.

Masimo Announces the Appointment of Three New Officers

Irvine, California. December 1, 2003. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry, today announced three new officers. Yoshi Tsutsumi has been appointed President of Asia/Pacific, Olivier Berthon has been appointed President, Europe, Africa, and Middle East, and Chris Kilpatrick has been appointed Executive Vice President, Business Development and General Counsel.

Yoshi Tsutsumi, President, Masimo Asia/Pacific, has been a close advisor and Board member of Masimo Japan. Prior to joining Masimo Japan's Board, Yoshi held various senior management positions at Colin in Japan. Yoshi was instrumental to Colin's growth and achievement of its mission. Yoshi has been involved in pulse oximetry's product development and marketing growth since its earliest stages.

Olivier Berthon, President, Masimo Europe, was with Kontron Equipment, Masimo's first European OEM partner, in the 1990s, first as a representative, later as a product manager in the critical care business unit. He began selling Masimo SET as part of Kontron's patient monitors in 1997 and became Masimo's first European employee in 1999 as OEM Business Development Manager. Olivier has brought Masimo SET to many key European medical centers, including Assistance Publique de Paris, the French Army, HCL de Lyon, University of Heidelberg, Hospital of Veldhoven and Birmingham Hospital.

Chris Kilpatrick, Executive Vice President Business Development and General Counsel, Masimo Corporation, was President of Interplay Productions and was a key member of management responsible for creating the strategy for Interplay's rapid growth and IPO during the period of 1994 to 1999. Chris has also been a Partner in the Corporate Department of Stradling, Yocca, Carlson & Rauth and the Chairman of the Corporate Group of the Irvine office of Arter & Hadden, for whom he represented companies covering a wide range of industries and size, with a particular focus on advising emerging growth companies. Since 2001, Chris has been Vice President of Business Development and General Counsel for Masimo.

Joe E. Kiani, CEO of Masimo Corporation, stated, "These three individuals have all been critical to Masimo's success to date. I am confident that Masimo's mission will continue to flourish under the leadership of these individuals and the rest of our executive team."

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at www.masimo.com.

Nellcor is Admonished by Researchers for Misrepresentations of Clinical Data

Milwaukee, WI, November 24, 2003 - Researchers from Children's Hospital of Wisconsin countered the false and misleading statements made in a Nellcor press release last week regarding the researchers' recently published clinical study.

"Nellcor's press release is very disturbing," stated Frederick A. Robertson, M.D., one of the study's authors. "Nellcor misrepresented the results and conclusions of the study by selectively reporting certain statistically insignificant data, while withholding statistically significant data that was clearly shown in a multiple-abstract presentation of our study. Clinicians rely on peer reviewed clinical data in making life or death decisions and any distortion of the results is a direct interference with that process. We have demanded that Nellcor immediately retract the false and misleading statements in its press release." Dr. Robertson continued, "Children's Hospital of Wisconsin converted all of its pulse oximeters from Nellcor to Masimo in September of this year because of the results of our year long head to head evaluation."

George Hoffman, M.D. Chair of Anesthesiology, Children's Hospital Wisconsin and one of the researchers in the study added, "We conducted multiple year long evaluations comparing Nellcor N-395 technology to Masimo SET, and have presented our findings in five separate abstracts describing differing performance characteristics of the newer generation oximeters. The aforementioned press release significantly distorts our main conclusion, that accuracy at low saturation may be affected by algorithms, present in both devices, to improve artifact rejection. The results of our performance comparisons were substantially more complicated, revealing that these new devices have both overt and subtle differences in operating characteristics which make them substantially non-equivalent with respect to bias, precision, and data availability across ranges of saturation and signal integrity."

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on www.masimo.com.

Masimo Joins AARC Corporate Partner Program

DALLAS (Nov. 10, 2003) - The American Association for Respiratory Care (AARC) is pleased to welcome Masimo Corporation as a new Corporate Partner.

The partnership is expected to greatly enhance collaboration between Masimo, innovator and leader of motion and low perfusion tolerant pulse oximetry, a technology that noninvasively measures arterial oxygen saturation, and the AARC, the national organization representing respiratory therapists.
"We are extremely pleased to have Masimo join the growing number of respiratory care companies showing their support for the nation's respiratory therapists through the AARC's Corporate Partner Program," says Kevin Shrake, MA, RRT, FAARC, AARC's Chief Operating Officer. "We've always had close ties with Masimo, but the partnership will provide additional opportunities to work together for the benefit of patients suffering from respiratory disease."

As a corporate partner, Masimo will join forces with the only professional association for respiratory therapists, supporting much needed educational and research efforts aimed at ensuring RTs have the information and tools they need to deliver top quality care to adults and children with asthma, chronic obstructive pulmonary disease, cystic fibrosis, and other respiratory problems.
In return for their investment, Corporate Partners gain professional and consumer recognition and appreciation for their commitment to the respiratory profession and to respiratory health through advertising and marketing opportunities available exclusively through the AARC.

Says Shrake, "The companies that make up the respiratory care industry are an important part of our community. We rely on them to provide us with the cutting-edge technologies we need to deliver care, and they rely on us to provide input into research and development of their new and ongoing products."

He concludes, "The Corporate Partner Program is a win-win situation for us all, because it formalizes the strong bond we've always enjoyed."

Masimo is committed to improving patient outcomes and reducing cost of care by working with dedicated hospital staff to convert health care institutions around the world to Masimo SET pulse oximetry technology. They are accomplishing this goal by directly marketing complete pulse oximetry solutions to hospitals, as well as by partnering with patient monitoring companies to create innovative, cost-effective acquisition programs for Masimo SET products. Masimo Corporation is located in Irvine, California.

Kevin Mosher, President, Masimo Americas stated, "Masimo is pleased to support the education, research and overall efforts of the AARC aimed at improving the care and quality of life for patients suffering from respiratory disease. The Respiratory Therapy community has been instrumental in validating the improvement in patient care and safety that Masimo SET has brought to patient monitoring, and we are delighted to be associated with the dedication and professionalism of this caregiver group."

The American Association for Respiratory care, the only professional membership association for respiratory therapists, focuses primarily on respiratory therapy education and research. Its goals are to ensure that respiratory patients receive safe and effective care from qualified professionals and to benefit respiratory health care providers. The Association continues to advocate, on behalf of pulmonary patients, for appropriate access to respiratory services provided by qualified professionals.

Frost & Sullivan Honors Masimo For Its Pioneering Signal Extraction Technology

SAN DIEGO, Nov 6, 2003 - At last night's 2003 Global Excellence in Healthcare & Life Sciences Awards Banquet, Frost & Sullivan named Masimo Corporation as the recipient of the 2003 Patient Monitoring Technology of the Year Award.

Masimo Corporation's innovative Signal Extraction Technology (Masimo SET^®") modernized the pulse oximetry and patient monitoring markets with its ease of use and breakthrough performance. Its ability to noninvasively measure oxygen saturation levels in high-risk and difficult patients, such as people with very low levels of perfusion and those actively in motion, has created widespread demand by physicians.

"Masimo's engineering design and skilled development of highly specific algorithms have made its technology highly sought after," states Katherine Shariq, industry analyst with Frost & Sullivan. "Due to the company's innovations, the pulse oximetry market has been reenergized and the use of pulse oximetry solutions for continuous measurements among high-risk patients has expanded."

This award recognizes Masimo's contribution to medicine and patient care through its innovation, engineering expertise, and diligence in getting its Masimo SET^®" technology accepted and used in the patient monitoring market. Masimo currently maintains licensing agreements with more than 35 international patient monitoring equipment providers and operates a growing stand-alone pulse oximeter business.

With Masimo SET^®" acknowledged as a new technology standard most hospitals and caregivers are making the shift to "next-generation" pulse oximetry solutions to monitor their patients. Masimo deserves this award for its commitment to patient care, reliability, and the ease of use of its products.

Joe E. Kiani, Chairman & CEO of Masimo stated, "On behalf of the Masimo team, both those inside and outside the company, I would like to thank Frost and Sullivan for bestowing upon us this award. This award not only encourages us to do more, but hopefully it encourages other people to dedicate themselves to the advancement of patient care."

Every year, Frost & Sullivan honors the company that introduces a technology with the ability to influence and impact R&D focus and competitive posture in several market segments. The technology also shows potential to become an industry standard or achieve a high degree of market acceptance.

Held in San Diego, Calif., the Frost & Sullivan banquet honored world-class companies for outstanding performance and achievements in the healthcare industry. An annual event, the banquet recognizes the quality and merit of these distinguished companies.

About Masimo

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective published studies have demonstrated that Masimo SET is the safest and most effective pulse oximetry technology in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70 percent of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, Calif. Additional information about Masimo and its products can be found on www.masimo.com.

About Frost & Sullivan

Founded in 1961, Frost & Sullivan is recognized as a global leader in growth consulting. Frost & Sullivan Awards are presented to companies that demonstrate excellence in their industry, commending the diligence, commitment, and innovative business strategies required to advance in the global marketplace. Frost & Sullivan rigorously analyzes specific criteria to determine award recipients in a vast variety of market industries and landscapes. For further information, visit www.frost.com.

California Pacific Medical Center Converts to Masimo SET Oximetry

Hospital Cites Improved Care & Dramatic Reduction in False Alarms and Noise

SAN FRANCISCO, California. November 3, 2003. California Pacific Medical Center, a Sutter Health Affiliate and one of the largest facilities in Northern California, has standardized on Masimo SET^® (Signal Extraction Technology^™) oximetry in its Pediatric and NICU settings. The conversion raises California Pacific's standard of care in noninvasive vital signs monitoring for its some 200,000 patients served annually. In California Pacific's in-house comparison of Masimo versus Nellcor pulse oximetry, Masimo was proven to consistently deliver the best results during conditions of patient motion and low perfusion, as occurs with many patients. This conclusion corroborates the many industry awards and over 70 independent and objective clinical studies supporting Masimo SET. The conversion is consistent with California Pacific's commitment to provide the highest quality healthcare available.

Judi Kane, Clinical Coordinator for Respiratory Therapy in the NICU, said, "When we used Nellcor oximetry, we had the typical problems of data dropping out during motion with pediatric patients and during motion and poor perfusion with babies and some of our elderly patients. We had all lived with that for years, but when I found out about Masimo technology, I brought it to the hospital and began running tests. In an early application, we had a newborn on oxygen and were getting low readings from the non-Masimo oximeter. After a couple of days of oxygen therapy, we hooked up a Masimo unit and found adequate oxygenation. After running a blood gas to confirm, we discontinued the oxygen and the infant was fine. This type of accuracy from Masimo was often repeated so we decided to implement it. Post-conversion, I have no problem 99.9% of the time. We use Masimo with newborns in the delivery room, we use it for transports, and we use it on elderly patients. The other thing we hadn't counted on is that our unit is now 80% quieter than it ever was because of Masimo's reduction of false alarms. Our patients and clinicians are well-served by this conversion."

Kevin Mosher, President, Masimo Americas, stated, "California Pacific is a measure of excellence in healthcare, both as a treatment center and as a research institution. Its in-house conclusion that Masimo offers the highest available pulse oximetry performance mirrors the vast body of literature comparing Masimo SET to other "next generation" pulse oximetry providers. Masimo is proud to serve such an elite institution that serves so many families in the San Francisco area."

About California Pacific Medical Center

California Pacific Medical Center is one of the largest private, not-for-profit, academic medical centers in Northern California and is a Sutter Health affiliate. We are a tertiary referral center providing access to leading edge medicine while delivering the best possible personalized care. We provide a wide variety of services, including acute, post-acute and outpatient hospital care; home care and hospice services; preventive and complementary care and health education. Through our medical education program and our Research Institute, physicians at California Pacific are able to bring health care innovation to the bedside.

The Medical Center enjoys a rich history of caring for the people of San Francisco since it is comprised of the three oldest hospitals in the City. At every stage of life, California Pacific is here to provide a continuum of care for our community and to set the standard for What a Medical Center Needs to Be...

About Masimo Corporation

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on www.masimo.com.

Clinical Researchers Conclude the Fidelity of Masimo SET^® Will Lead to Improved Obstructive Sleep Apnea Diagnosis

Irvine, California, October 28, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced the presentation of a new paper at the Australasian Sleep Association Conference, entitled, "Performance in Attended and Unattended Settings of a New High Sampling Rate Oximeter and DIP Rate Software in the Diagnosis of Obstructive Sleep Apnea," by Nick Antic, et al. The researchers conclude that the fidelity, or high sampling rate, of the Masimo SET oximeter enables detection of "dips" in oxygen saturation missed by other pulse oximeters.

Obstructive Sleep Apnea (OSA) affects 12 to 18 million people in the United States alone and has been linked to heart attack, stroke, decreased productivity, and overall decrease in quality of life.
Yet, the diagnosis of obstructive sleep apnea remains a challenge in sleep laboratories worldwide. Overnight home oximetry, with its cost-effectiveness and ease for patients, can be a solution to the problem, but pulse oximeters have not had the combination of sensitivity, specificity, and fidelity necessary to track true dips in oxygenation fast enough for clinicians to confidently diagnose the condition. Masimo's newest oximetry technologies, Masimo SET^® V3 and Masimo SET V4, when used with Masimo SET LNOP^® sensors, can track and record patient data with unprecedented fidelity. By enabling either FastSat^™ mode or the 2-second averaging mode, Masimo SET provides a far more complete analysis of a patient's sleeping patterns than has been previously available with other technologies, including other "next generation" technologies.

Dr. Antic commented, "In our study, the Masimo oximeter has performed with great reliability in the home and laboratory environments. The combination of Masimo oximetry and dip-rate software has provided a simple, automated option which appears capable of accurately ruling in moderate to severe OSA in a high proportion of patients. We intend to perform full PSG [polysomnography] on those with negative oximetry studies as we are not trying to rule out OSA with the current dip-rate settings. It has been of interest that the >2% Dip-rate has compared best to full PSG and it seems likely the fast sampling and averaging time of the Masimo contributes to the detection of these lesser oximetry dips."

Robert Whitman, Ph.D., D, ABSM, RRT, RPFT, Director of the Sleep Disorders Center and Pulmonary Diagnostics at the University of Kansas City Medical Center, has done similar research on Masimo SET oximetry in OSA tests. In an interview regarding Dr. Antic's study, Dr. Whitman stated, "The fidelity of Masimo SET improves CPAP [Continuous Positive Airway Pressure]-qualifying diagnoses, especially in patients who have minimal or mild levels of desaturation associated with their OSA." Dr. Whitman also stated, in a report entitled "The New Days of Sleep Apnea Diagnosis and Treatment," "Masimo oximetry solves a big problem. Previously, testing patients in the home would only yield a few hours of acceptable data. You'd have to have a patient come in every night if you were going to get any good results at all. The Masimo SET pulse oximeter can yield reliable readings for three days. Thus, we are able to do serial testing so that we can be assured we have the right pressure set for the patient to get the maximum benefit from CPAP. I couldn't imagine doing this before the Masimo SET Radical."

Joe E. Kiani, Founder & CEO of Masimo stated, "We are delighted to see researchers finding new applications for pulse oximetry with the advent of Masimo SET technology. Our goal was to solve the problems of false alarms and make pulse oximetry a foul weather friend. It's nice to see that we have not only accomplished our stated goal, but that the Masimo SET solution has broadened the clinical utility of pulse oximetry. We have seen clinicians use Masimo SET oximetry to monitor patients undergoing bypass in the Operating Room, to titrate oxygen better on neonates and adults in the Intensive Care Unit, to improve vigilance in the General Ward, diagnose the severity of the preterm infant, screen infants born with antenatal infection, and now diagnose patients with OSA at home. Obstructive Sleep Apnea is a serious medical issue with broad social implications. We hope that widespread use of Masimo SET oximetry in early diagnosis of sleep apnea can improve the lives of people worldwide."

Masimo, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the noninvasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. Over 70 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology is the safest and most effective pulse oximeter in the world. To date, Masimo has licensed its Signal Extraction Pulse Oximetry technology to over 35 international patient monitoring system providers, which make up over 70% of the world's pulse oximeter shipments. Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found on www.masimo.com.

Eight New Independent Studies Presented at The 56th Annual Meeting of the American Society of Anesthesiologists Further Demonstrate the Clinical Advantages of Masimo SET Pulse Oximetry

SAN FRANCISCO, California. October 15, 2003. During the 56th ASA Meeting, eight new studies were presented, adding to the overwhelming number of published clinical studies supporting Masimo SET as the New Standard of Care for Monitoring Patients at Risk of Respiratory and Cardiovascular Failure. 

Robert Whitman, Ph.D., ABSM, RRT, RPFT, et al from the University of Kansas Medical Center, Kansas City, KS, compared the performance of the Masimo SET Radical^® and the Tyco-Nellcor N595 Oximax with Maxfast forehead sensor to the Masimo SET Radical in an evaluation of possible obstructive sleep disordered breathing on 20 patients. Dr. Whitman stated, "No artifact was observed with the Masimo SET system using the digit sensors. The Nellcor Max-Fast reflectance forehead sensor failed to provide accurate SpO2 data in 40% of the patients undergoing polysomnography. The use of this (forehead) sensor during anesthesia could negatively impact the therapeutic approach in patients with sleep apnea during pre-anesthesia and during post-anesthesia recovery."

Dr. Helmut Hager, Clinical Research Division, Dept. of Anesthesiology, Washington University, St. Louis, MO, presented research in which he compared the Masimo SET perfusion index (PI) with the forearm-fingertip gradient commonly used to assess arterio-venous shunt thermoregulatory vasomotion of patients undergoing anesthesia. Dr. Hager's results indicate that the Masimo SET perfusion index can monitor these changes more quickly and with better precision. Dr. Hager concluded, "The perfusion index may be a valuable tool for assessing changes in peripheral perfusion caused by an inhalation agent like sevoflurane. It might thus be of future value in assessment of perioperative changes in peripheral perfusion due to different anesthetic conditions." 

Dr. Mitchell Goldstein, MD FAAP, Queen of the Valley Hospital, West Covina, CA, presented three new neonatal studies to the delegates at ASA. The first study, "A Comparison of Two New Generation Pulse Oximeters: The Masimo SET Radical and the Philips Viridia C1.0," demonstrated that the Philips Viridia zeroed out 10 times more often than the Radical, and these periods of non-monitoring lasted more than twenty-five times as long as the Radical. Dr. Goldstein's second study, "Is Pulse Search Technology a Predictor of Unreliable Saturation Monitoring?" compared the Masimo SET Radical with Tyco-Nellcor's latest N-595, and N-395. Dr. Goldstein reported that N395 and N595 falsely alarmed 3 to 6 times more than Masimo SET. Dr. Goldstein's final study, "A Survey of Indicators of Pulse Oximetry Validity," compared the accuracy and reliability of Masimo's Low Signal IQ message display to N-595 Motion Light indicator in signaling potentially erroneous data. The Nellcor N-595's Motion Light indicator falsely signaled suspect data 30 times more often than the Masimo SET Low Signal IQ message display.

Dr. Frederick Robertson, III, assistant professor of Anesthesiology, Medical College of Wisconsin, presented a comparison of Masimo SET, Nellcor N-395, and GE Solar 8000 pulse oximetry technologies with respect to data availability and agreement in chronically desaturated children (ages 4 months to 4 years). His findings showed that data availability with Masimo SET was greater, by a statistically significant margin, than the Nellcor N-395, and the GE Solar 8000. The CHW study also demonstrated that the Low Signal IQT message display of Masimo SET was more accurate than the Nellcor N-395's warning indicator (Motion Light Indicator) for suspect data. 

Dr. Rebecca Syring, assistant professor of Critical Care Medicine at Penn State School of Veterinary Medicine, presented the results of her study, "Respiratory Variations in SpO2 with a Fast Pulse Oximeter," which described the ability of the Masimo SET FastSatT algorithm to track mechanical ventilation and cyclical recruitment in an animal model that simulates patients at risk for ventilator-associated lung injury (VALI). Dr. Syring noted, Critical to this kind of monitoring is speed of measurement, Dr. Syring noted, because cyclical recruitment of atelectasis (CR) may cause arterial PO2 changes in as brief a period as one breath. Dr. Syring commented, "Because this new technology is noninvasive and could be applied routinely in mechanically ventilated patients, this new device has potential to provide bedside assessment of cyclical recruitment and adjustment of mechanical ventilation to reduce VALI." 

T. Asahina, MD and Dr. Aozaki, Professor of Anesthesiology at Tokyo Women's Medical College, studied Masimo SET Oximetry during cardiopulmonary bypass, where oxygenation is often only intermittently monitored via arterial blood gas analysis. During 10 cardiac surgical cased with CPB, a blood pressure cuff was attached to the right forearm beneath the elbow. The cuff was inflated and deflated from 0 to 30-50 mm Hg pressure at frequency of 60 beats per minute. During total bypass, with oscillation by the pump, the Masimo SET Radical measured arterial oxygen saturation that correlated extremely well with ABG measurement. Correlation coefficient, R was over 99%.

Joe E. Kiani, Founder & CEO of Masimo stated, "The number of independent clinical literature supporting Masimo SET as the standard of care for pulse oximetry has now risen to greater than 70. 72 of the 75 independent studies clearly favor Masimo SET as the new standard of care. In addition, Masimo SET has received numerous awards, including the "New Standard of Care" award, which was awarded this year by Frost & Sullivan to Masimo for its contribution to patient care with the advent of Masimo SET."

St. Luke's Episcopal Health System Converts to Masimo SET Oximetry

Houston, Texas, October 6, 2003. St. Luke's Episcopal Health System, home of the Texas Heart Institute and one of the largest cardiovascular centers in the world, has converted to Masimo SET^® pulse oximetry. Pulse rate and arterial blood oxygenation monitoring by pulse oximetry in critical care settings has become a standard of care, but some patient conditions have proven challenging to most pulse oximetry providers. Masimo's innovation and superior refinement of next generation pulse oximetry technology, however, has extended pulse oximetry's benefits to previously challenging cases, such as poorly perfused patients common to cardiac care facilities. Conversion to this standard-setting technology is part of St. Luke's mission to provide its patients with comprehensive, high-level care. Clinicians at St. Luke's stated increased accuracy and ease of implementation as central features of the conversion to Masimo SET Oximetry.

John Sabo, MS, RN, RRT, Administrative Director of Respiratory Care and Anesthesia, commented, "As we began to replace our monitoring technology, we saw the opportunity to upgrade our pulse oximetry. We had been using conventional pulse oximetry but we wanted something with greater accuracy and a higher threshold for our cardiac patients with poor perfusion. We evaluated newer generation oximeters and chose Masimo based on overall performance. We've minimized, if not eliminated, the issues we had with SpO2 monitoring in ICUs, cardiovascular operating and recovery rooms."

Wadie Williams, RRT, CerAT, Manager of Respiratory Care and Anesthesia, said, "The conversion is now finished and we're very satisfied with the implementation process and Masimo's effort. One of the main concerns in improving technology is keeping the physicians and nurses from worrying about interrupting patient care and decreasing patient safety, which Masimo addressed appropriately. Masimo converted all of the units without interrupting the flow of patient care and sacrificing safety. The inservices for physicians, nurses, therapists and other care providers was flexible and the Masimo team was responsive."

Kevin Mosher, President, Masimo Americas, said, "We are delighted to offer our standard of care pulse oximetry technology to the patients of St. Luke's. Masimo's ability to handle poor perfusion and rapid desaturation makes Masimo ideally suited to facilities dedicated to the best in cardiac care. We innovated and developed motion and low perfusion tolerant pulse oximetry with these kinds of challenging conditions in mind. St. Luke's is a well-respected, premier healthcare facility, and Masimo is proud to be a part of St. Luke's commitment to quality."

About St. Luke's Episcopal Health System
St. Luke's Episcopal Health System is a comprehensive health system that meets the primary and tertiary healthcare needs of the Houston community. Established by the Episcopal Diocese of Texas, the System includes St. Luke's Episcopal Hospital, the St. Luke's Episcopal Health Network, St. Luke's Episcopal Health Charities and most recently, the Kelsey--Seybold Management, LLP. St. Luke's is home to the world-renowned Texas Heart Institute, founded in 1962. The Texas Heart Institute at St. Luke is consistently ranked in the top 10 cardiovascular centers in the United States by U.S. News & World Report.

Advocate Health Care Performs System- Wide Conversion to Masimo SET^® Oximetry

IRVINE, California, September 29, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced that Advocate Health Care, based in Oak Brook, Ill, has selected Masimo Signal Extraction Technology^™ (Masimo SET^®) for their pulse oximetry needs. Advocate is comprised of eight acute care hospitals, two children's hospitals, and 4,600 physicians, and is consistently recognized as one of the top hospital systems in the country. Advocate selected Masimo after an extensive comparison of next generation pulse oximetry technology.

"The decision to switch from our current technology platform to Masimo is considered part of our 'Program to Promote Clinical Excellence,' one of the most aggressive capital improvement efforts in our history, wherein we seek new technology at the forefront of patient care. Masimo has exceeded our demanding criteria," stated Darin Roark, director of clinical products review at Advocate. "With a healthcare system of our size - eight hospitals representing nearly 3000 beds - a system wide conversion brings the fear of spreading the conversion team and its resources too thin, the primary danger being a reduction in patient safety. I commend the Masimo team for making a very difficult process easy and exciting. A sense of professional competence, established at the pre-implementation meeting and the kick-off luncheon, continues as the final ends of the conversion are now being tied. Masimo helped our staff feel at ease by making training and technical support available 24 hours a day."

Kevin Mosher, President, Masimo Americas, stated, "Masimo is delighted to serve Advocate Health Care. Advocate is respected not only as one of the largest systems in the nation, but as one of the finest. Its recent inclusion in US News and World Report's "America's Best Hospitals" list (Lutheran General) validates Advocate's ongoing commitment to patient safety and clinical excellence. Masimo is proud that Advocate's rigorous pulse oximetry clinical comparison compelled Advocate to undertake such a large-scale conversion. We believe an increase in clinical effectiveness and process of care will attend the new implementation of Masimo SET Pulse Oximetry at Advocate."

About Advocate Health Care System

Oak Brook, Ill., based Advocate Health Care, the largest health care provider in Illinois, has ranked among the nation's top 10 health care systems for six consecutive years. A faith-based, non-profit system, Advocate is related to both the Evangelical Lutheran Church in American and the United Church of Christ. Advocate's 200+ sites of care in metropolitan Chicago include eight acute care hospitals and two children's hospitals, a home health care company and three of Chicago's largest medical groups.

With more then 24,900 employees, Advocate is the second largest employer in Chicago and the only health care provider listed among the 25 best places to work in Chicago. Through a long-term academic and teaching affiliation with the University of Illinois at Chicago Health Sciences Center, Advocate trains more resident physicians than any non-university teaching hospital in Illinois. For more information about Advocate Health Care, visit www.advocatehealth.com.

Court Finds Masimo Does Not Infringe Two Nellcor Patents

Masimo Continues to Pursue Its Infringement Claims Against Nellcor--Trial Scheduled for February

Irvine, California, September 24, 2003 - The Federal District Court in Los Angeles ruled that Masimo does not infringe two Nellcor patents. Nellcor asserted one of these patents against Masimo's advanced signal processing techniques and the other against Masimo's proprietary SatShare^™ feature.

"We have maintained that Nellcor's assertions of infringement were merely a defensive response to our patent infringement suit filed against Nellcor in 1999," stated Joe E. Kiani, Chief Executive Officer of Masimo. "It is great to have the cloud over these products lifted. We remain confident that the Court will prohibit Nellcor from infringing Masimo's patents on motion and low perfusion tolerant pulse oximeters."

Masimo sued Nellcor, a Tyco Company, in 1999 for infringing Masimo's innovative motion-tolerant pulse oximetry patents. Masimo's claims for patent infringement against Nellcor's Oximax and Oxismart XL pulse oximeters are scheduled for trial in February 2004.

Children's Hospital of Wisconsin Converts to Masimo SET^® Oximetry

Irvine, California, September 22, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced that Children's Hospital of Wisconsin has standardized on Masimo SET^® (Signal Extraction Technology^™) pulse oximetry hospital wide. The Children's Hospital of Wisconsin conversion follows an extensive side-by-side evaluation of Masimo's Radical pulse oximeter and advanced pulse oximetry technology from a major competitor. Researchers at Children's Hospital of Wisconsin concluded that Masimo offers a high degree of reliability and accuracy during clinical use.

"The pulse oximetry evaluation at Children's Hospital of Wisconsin was extensive," said Terry Hensler, Manager of Clinical Engineering at Children's Hospital of Wisconsin. "Twenty five patients were studied for a total of 95.4 hours. Data from both devices were fed to a computer. In the end, we found that the Masimo product provided reliable measurements in the presence of motion and low perfusion demonstrating few false alarms and few missed desaturations - and that ultimately our patients would be better served once Masimo was fully integrated. A major factor in the decision was that we were able to offer all of our patients the Masimo SET technology in all of our bedside monitors due to the fact that Masimo is the only 'next generation' pulse oximetry technology fully supported by our entire patient monitoring product line."

Dick Dooley, Director of Materials Services, said, "We would like to commend Masimo for their outstanding service after the sale. When several issues arose both pre and post-implementation, Masimo's team response from local representatives to senior executives exceeded our expectations. We are very pleased to have a partner like the Masimo Corporation."

"Children's Hospital of Wisconsin is a world-class children's hospital that represents the finest in patient care and serves some of the most fragile patients," stated Kevin Mosher, President, Masimo Americas. "We were impressed by the Children's Hospital of Wisconsin commitment to provide cutting-edge patient care across the broad spectrum of pediatric medicine. They join a growing list of children's hospitals making Masimo SET their standard of care for pulse oximetry. Masimo looks forward to exceeding their appropriately high expectations."

About Children's Hospital of Wisconsin
Children's Hospital of Wisconsin, founded in 1894, is one of the leading centers for pediatric health care in the United States. Private, independent and not-for-profit, the hospital serves children and families from Wisconsin, the Upper Peninsula of Michigan, northern Illinois and beyond. Children's Hospital of Wisconsin treats thousands of children each year. In 2002, more than 20,000 infants, children and adolescents were admitted and more than 234,000 were seen in the hospital's specialty outpatient clinics. The hospital is a leader in bone marrow transplants, particularly between unrelated donors and recipients, as well as in providing care for critically ill newborns and children with congenital heart disease. Located about six miles west of downtown Milwaukee on the grounds of the Milwaukee Regional Medical Center, Children's Hospital of Wisconsin is a member of Children's Hospital and Health System and an affiliate of the Medical College of Wisconsin. Additional information about Children's Hospital of Wisconsin can be found at www.chw.org.

Masimo Releases The 2004 RADICAL

Irvine, California, September 4, 2003 - Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced the release of the 2004 Radical^™. The 2004 Radical debuts:

• Masimo SET^® V4.1, the world's highest sensitivity, specificity, and fidelity pulse oximetry technology.
• Adaptive Probe Off Detection^™ Technology, or APOD. APOD^™ is designed to minimize the risk of false measurement when the probe becomes detached from the patient. APOD is designed to immediately alarm the clinician upon probe detachment, thus eliminating the risk of "false reassurance."
• ClearVue^™ blue LCD display technology, the highest resolution blue LCD display. Customers will be able to choose between ClearVue blue or green display.
• A6^™ alarm system, delivering up to 85 decibels of sound during alarm. The new 85-decibel alarm satisfies JCAHO's recently adopted National Patient Safety Goal #6 without requiring the purchase of additional equipment such as remote alarm systems. JCAHO requires hospitals to ensure that alarms are "sufficiently audible with respect to distances and competing noise within the unit."
• Equipped standard with detachable battery providing up to 8 hours of use, as well as an optional extended battery giving up to 36 hours of battery life, providing a 4 to 18-fold increase in battery life when compared to competing standalone pulse oximeters.
• The 2004 Radical also incorporates the features that have made the Radical revolutionary: SatShare^™, allowing patient monitors to be easily upgraded to Masimo SET; ultra low weight; detachable handheld pulse oximeter for maximum portability; Rotational Screen^™for horizontal or vertical positioning; Signal IQ^™; Perfusion Index (PI), and FastSat^™.

Wayne Fortier, Clinical Manager of Respiratory Care Services at North Bay Medical Center and Vaca Valley Hospital, said, "We have evaluated and chosen the Masimo SET Radical because we found many features that help us improve patient care and meet the new guidelines from JCAHO regarding audible and effective alarms. According to independent literature on "Next Generation" pulse oximetry, Masimo SET is the only motion tolerant pulse oximetry technology that does not freeze data during patient motion. Masimo SET not only virtually eliminates false alarms, but with its true motion rejection technology increases the detection of true alarms. False alarms can desensitize clinicians to the real alarms, but masking real alarms is a non starter."

Joe E. Kiani, CEO & Founder of Masimo, stated: "We developed the 2004 Radical in conjunction with our customers and in review of the new National Patient Safety Goal #6 from JCAHO requiring audible and effective alarms. We not only improved the sensitivity and specificity of the alarms above any other pulse oximeter technology, including Masimo SET V3, but we decided to build a variable alarm tone that allows for an 85-decibel alert, which we coined A6. Our team in conjunction with our advisors and customers created a hospital selectable menu to simplify the clinician's interaction with the monitor. Hospitals can set up hospital-wide or unit-wide default settings, or they can lock the unit into a menu that allows for only basic manipulation of the Radical's features."

In addition to the improvements in alarm vigilance, the new Masimo SET Radical continues to provide Nurse Call, Analog Output, and Serial Output for connection to networks of the hospital's choosing.

Washington Adventist Hospital Converts to Masimo SET^® Oximetry

Irvine, California, August 25, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced that Washington Adventist Hospital in Takoma Park, Maryland, has standardized on Masimo Signal Extraction Technology ^™ (Masimo SET) for its pulse oximetry needs. Part of Adventist HealthCare, a non-profit health care system, Washington Adventist Hospital is a 300-bed facility with 750 physicians. Masimo was chosen based on Washington Adventist Hospital's conclusion that the monitoring of patients who are poorly perfused will improve and operational expenditures will significantly lessen with Masimo SET oximetry.

"Masimo has made several contributions to the monitoring of patients who are poorly perfused," commented Bonnie Neibauer, nurse manager of the cardiac intensive care unit. "First, the variable sensitivity settings, MAX, Normal & APOD [Adaptive Probe Off Detection], increase the oximeter's ability to detect a signal in some of our cardiac patients who suffer episodes of very poor circulation. Secondly, the perfusion index is a reliable clinical guide for gauging the quality of the received signal. I anticipate gaining the ability to make quicker and more precise assessments."

Zelick Stewartson, Manager of Respiratory Care, stated, "Conversion to the Masimo system provides an enhanced level of service to our patients, consistent with our hospital's ongoing desire to ensure our patients receive the best care available. Patient safety and care are central to our mission - Masimo will enhance both."

Mr. Stewartson continued, "Without the demonstrated excellence of Masimo SET, we would not have made this conversion. But from a process of care standpoint, it is exciting to switch to a cutting edge technology that will also lower our costs. Masimo's improved sensor life should reduce what we currently pay for pulse oximetry."

Kevin Mosher, President, Masimo Americas, stated, "Washington Adventist Hospital is a top tier health care facility and the only cardiac center in Montgomery County. Their conversion follows an extensive evaluation of Masimo SET versus other next generation pulse oximeters. Their conclusions are consistent with the large volume of clinical and laboratory studies that demonstrate the standard-setting superiority of Masimo SET pulse oximetry."

About Washington Adventist Hospital:
Washington Adventist Hospital, located in Takoma Park, MD, is directly adjacent to Washington, DC. When it was originally founded in 1907 as the Washington Sanitarium, this facility was on the underdeveloped fringes of the nation's capital. Today, Washington Adventist Hospital is a 300-bed, state-of-the-art acute care facility serving a culturally diverse urban community. Washington Adventist Hospital is Montgomery County's only complete cardiac center, performing 800 open heart surgeries and more than 6,000 heart catheterizations each year. A fast-paced emergency department provides round-the-clock, high-volume medical and nursing challenges throughout the year. The hospital employs nearly 2,000 people and has a medical staff of 750 physicians.

Researchers Use Pulse Oximetry to Screen Newborns for Congenital Heart Disease

Irvine, California, August 20, 2003. Masimo, the innovator and leader of motion and low perfusion tolerant pulse oximetry, today announced the publication of a new study in the March issue of Pediatrics indicating pulse oximetry as a useful diagnostic device in screening infants for congenital heart disease. The researchers conclude that a program of pulse oximetry screening of asymptomatic newborns for critical congenital cardiovascular malformation (CCVM) enables the detection of these life-threatening conditions prior to hospital discharge.

Congenital cardiovascular malformation is relatively common (5 - 10 of every 1000 live births) and is among the leading causes of death within the first year. The signs of CCVM, however, are often undetected during the early newborn period, and no CCVM screening program has been implemented. A group of researchers, led by Dr. Robert Koppel from Schneider Children's Hospital, New Hyde Park, New York, performed an extensive study of pulse oximetry's effectiveness in detecting asymptomatic CCVM. They believed that a screening protocol using pulse oximetry administered in conjunction with state-mandated screening could detect cases of CCVM that are missed without such a protocol. The results of their study showed that pulse oximetry screening had a positive predictive value of 75%.

Dr. Koppel commented, "As pulse oximetry is noninvasive, without harmful side-effects, and already in widespread use in the NICU and in normal newborn nurseries, an expanded research effort could confirm the need for this very easy, inexpensive and effective screening program."

"Pediatric and neonatal care clinicians have relied upon pulse oximetry for some time," said Mike Petterson, Director of Clinical Affairs of Masimo. "Now, with the heightened sensitivity of certain next generation pulse oximetry technologies, we are beginning to see a culture of experimentation. It is so gratifying to witness the creativity of clinicians aided by a powerful measurement tool. A few months ago, Dr. Augusto Sola of Emory University implemented an oxygenation protocol including Masimo SET pulse oximetry that has significantly reduced the incidence of ROP (infant eye disease). Now, Dr. Robert Koppel and his team have laid the foundation for a similarly exciting application - detecting asymptomatic infants with serious heart defects."

Children's Hospital of Pittsburgh Converts to Masimo SET^® Oximetry

Children's cites improved clinical performance and lowered costs as reasons for Masimo conversion

Irvine, California, August 5, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced that Children's Hospital of Pittsburgh in Pittsburgh, Pennsylvania, has standardized on Masimo Signal Extraction Technology ^™ (Masimo SET) for their pulse oximetry needs. Children's, ranked among the top 10 children's hospitals in the country by U.S. News & World Report, performed a system-wide conversion to Masimo SET following an evaluation of several "next generation" pulse oximeters. Masimo was chosen based on Children's determination that Masimo SET would enhance clinical performance and reduce operational expenditures.

"Children's is eager to realize the benefits of Masimo pulse oximetry. Their improved sensor design, their contribution to a very successful ROP protocol, and the large body of clinical support for Masimo convinced us to switch from Nellcor," stated Rich Straub, director of biomedical for Children's Hospital of Pittsburgh. "One of the major considerations in hospital conversions, however, is the complexity of the task and the coordination required to do it safely and efficiently. I was very impressed by the ease of this conversion. Hospital operations were not hampered and I never felt that patient safety was compromised. The Masimo team did a fine job."

Kevin Mosher, President, Masimo Americas, stated, "We are honored that Children's Hospital of Pittsburgh, one of the top hospitals in the country, selected Masimo SET technology. Children's Hospital of Pittsburgh is recognized for their leadership within the medical community for setting standards of excellence and innovation in the delivery of health care, and their selection of Masimo SET pulse oximetry is a real testimonial to the performance of our technology."

About Children's Hospital of Pittsburgh

Children's, located in Pittsburgh, Pennsylvania, is the only hospital in western Pennsylvania dedicated solely to the care of infants, children, and young adults. The hospital has been named consistently to several elite lists of pediatric health care facilities. This recognition includes being ranked as one of the top 10 children's hospitals in the country by U.S. News & World Report and seventh in funding provided by the National Institutes of Health. Children's also is renowned for cardiology, cardiothoracic surgery, critical care medicine, diabetes, hematology/oncology, neurosurgery, organ and tissue transplantation, orthopaedics, otolaryngology and surgery. The hospital also is the only accredited Level 1 Pediatric Regional Resource Trauma Center in western Pennsylvania and one of only 15 in the country.

Masimo Reports on First Half 2003 Results

Company reports accelerating unit shipments and the accomplishment of key milestones

Irvine, California, July 29, 2003. Masimo, the innovator of low perfusion and motion tolerant pulse oximetry, today announced that Masimo SET^® Radical pulse oximetry unit sales grew by over 85% while the sale of the Masimo SET LNOP single patient adhesive pulse oximetry sensors grew by over 50% for the first half of 2003, compared to the first half of 2002. As of the end of June, the cumulative shipments of Masimo SET pulse oximetry systems topped 125,000.

Masimo also reported that leading hospital institutions continue to standardize upon Masimo SET pulse oximetry. Advocate Health, an eight-hospital IDN; Cape Fear Medical Center; Heartlands Hospital (Birmingham, UK); LeeSar Healthcare System, a four-hospital Integrated Delivery Network (IDN); Pittsburgh Children's Hospital; St Luc St Joseph's Hospital (Lyon, France); Washington and Shady Grove Adventist Hospitals were just some of the hospitals or hospital systems that chose to standardize on Masimo SET pulse oximetry during the first half of 2003.

Other first half milestones for Masimo included:

• Improved outcome study published in February issue of Pediatrics entitled, "Can Changes in Clinical Practice Decrease the Incidence of Retinopathy of Prematurity in Very Low Birth Weight Infants?" demonstrates dramatic reductions in ROP (infant eye damage or blindness) using a strict oxygen management protocol including the use of Masimo SET pulse oximetry.
• Reduced cost of care study published in Journal of Perinatology (2003; 23:133-135) indicates dramatic cost-savings when using Masimo over Nellcor sensors for neonatal care. The study showed that Masimo SET LNOP^® sensors lasted over twice as long as Nellcor's.
• Addition of the MedAssets HSCA Group Purchasing Organizations (GPOs) to Masimo's GPO contract portfolio.
• Release of latest software, Masimo SET V4.1, incorporating innovative advancement in probe off detection called APOD^™, or Adaptive Probe Off Detection and improved sensitivity and specificity.
• Release of MS-11, Masimo's latest Signal Extraction Pulse Oximetry^™ OEM board targeted for portable and telemetry applications. MS-11 Operates on 125 mw and is the size of a business card.
• The scope of Masimo's patents relating to breakthrough motion tolerant technology was confirmed by the California District Court.
• Frost & Sullivan's first "New Standard of Care in Patient Monitoring" award was bestowed upon Masimo for its breakthrough motion and low perfusion tolerant pulse oximetry. Frost & Sullivan, the leading market research organization stated in their market research report on pulse oximetry: "Masimo offers caregivers the opportunity to determine the levels of oxygen in the patient's arterial blood in those patients previously unable to be measured. Measuring oxygen saturation levels in patients with weak pluses or low blood volumes frequently left physicians working blind. As a result of this technological breakthrough there have been numerous success stories of physicians achieving solid success rates in patients, such as infants and respiratory patients, previously unable to be measured and regulated".

Joe E. Kiani, Founder and CEO of Masimo stated, "The first half of 2003 has been very eventful for Masimo. We are indeed seeing acceleration in the adoption of Masimo SET pulse oximetry. We are very proud of the accomplishments we have made as an organization, but I have to say the most rewarding is the article published in Pediatrics which showed a reduction in eye injury in babies in the neonatal intensive care unit, following the adoption of a strict oxygen management protocol that included the use of Masimo SET oximetry. This contribution to improved patient care is what we have long worked to accomplish. And we couldn't have accomplished it without caring clinicians using the best tools for the care of their patients".

Masimo Awarded Contract by Novation for Masimo SET^® Pulse Oximetry

Irvine, California, July 23, 2003. Masimo, the innovator of motion and low perfusion tolerant pulse oximetry, today announced that Novation, the nation's largest supply chain management company, has contracted with Masimo to offer Masimo Signal Extraction Technology (Masimo SET) to the more than 2,300 member health care organizations of VHA and University HealthSystem Consortium (UHC). VHA and UHC members will have access to Masimo's full line of sensors and pulse oximeters, including the latest Masimo SET V4 technology. The two-year, four-month agreement will become effective September 1, 2003.

Mark McKenna, President of Novation, stated, "Based on our review of industry research studies, clinical trends, and member input, we feel that Masimo will enhance Novation's portfolio of offerings. Adding a second manufacturer of pulse oximetry equipment gives VHA and UHC members a broader range of technology options."

Kevin Mosher, President, Masimo Americas, stated, "The new agreement between Masimo and Novation will benefit both companies and, most importantly, the hospitals and patients Novation represents. Additionally, we are pleased that Novation has made key changes to its committed program, OPPORTUNITY^® Spectrum, allowing hospital participants greater flexibility around the pulse oximetry product category.

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. Novation serves the purchasing needs of more than 2,300 members and affiliates of VHA and UHC. Novation also serves more than 5,400 members and clients of HealthCare Purchasing Partners International (HPPI), another group purchasing organization owned by VHA and UHC. Novation managed more than $21 billion in annual purchases for VHA, UHC and HPPI members in 2002. For more information, go to www.novationco.com.

VHA, also based in Irving, is a nationwide network of more than 2,200 leading community-owned health care organizations and their physicians. It comprises 26% of the nation's community hospitals. For more information, contact www.vha.com. UHC, based in Oak Brook, Ill., and representing 76% of the academic medical centers in the United States, is an alliance of 88 academic medical centers and 110 associate members. For more information, contact www.uhc.edu. HPPI, an Irving, Texas-based group purchasing organization that manages more than $1 billon in annual purchases, markets its services to organizations that do not belong to VHA or UHC. For more information, contact www.hppigpo.com.

Two New Reports Support the Performance and Value of Masimo SET^® Pulse Oximetry- Studies report Masimo SET contributes to lower hospital operating expenditures as well as improved diagnosis

Irvine, California, July 15, 2003. Masimo, the innovator of low perfusion and motion tolerant pulse oximetry, today announced the publication of two new case studies in prominent healthcare journals. The publication of these studies indicates an industry attentive and interested in the revolutionary progress Masimo is making in pulse oximetry with Masimo SET technology.

The July 2003 issue of Healthcare Purchasing News features a story entitled "Smart Choices Lead to Substantial Savings in Pulse Oximetry." Written by Barbara Jacobs, director of Critical Care/Respiratory Therapy at George Washington University Hospital in Washington, D.C., the article concentrates on the vast cost savings GWUH experienced as a result of a neonatal and adult intensive care unit conversion from Nellcor to Masimo SET pulse oximetry. The durability of Masimo's LNOP sensors, along with the nurses' confidence in using Masimo SET, enabled Jacobs to modify protocol and recognize actual pulse oximetry savings of over 50%, as of one year following conversion. The case study also reported that GWUH's findings were consistent with a recent multi-center hospital clinical study entitled "Longevity of Masimo and Nellcor Pulse Oximeter Sensors in the Care of Infants," Journal of Perinatology 2003; 23:133-135,in which the Masimo LNOP single patient adhesive sensors were shown to last over twice as long as Nellcor's sensors. "Smart Choices Lead to Substantial Savings in Pulse Oximetry" can be found online at www.hpnonline.com, under "Inside the Current Issue." GWUH had evaluated all competitive pulse oximeters, including the Tyco Nellcor N395 and N595 before converting hospital wide to Masimo SET.

The latest issue of Acuity Care Technology, published by Medical Equipment and Electronics News (MEEN), also has a case study entitled "The New Days of Sleep Apnea Diagnosis and Treatment", details one of the thought leaders in sleep research, Dr. Robert Whitman, experience using Masimo SET pulse oximetry to accelerate the advancement of Obstructive Sleep Apnea (OSA) diagnosis and follow up treatment in the Sleep Lab at the University of Kansas Medical Center. Dr. Whitman found that the superior reliability, sensitivity and specificity of Masimo SET pulse oximetry, coupled with the high fidelity offered by its FastSat^™ algorithm, enabled his lab to more reliably identify hypopneas (brief changes in arterial oxygen saturation) that were previously undetectable by pulse oximetry. He reported that Masimo SET had a greater fidelity in tracking these changes than conventional pulse oximeters, as well as other next generation oximeters including the Nellcor N-395, which would aid in the qualification of patients for CPAP treatment under the new Medicare guidelines (coverage Decision Memorandum for CPAP, October 30, 2001).

Kevin Mosher, President, Masimo Americas, stated, "With over 60 independent and objective studies demonstrating the superior performance of Masimo SET pulse oximetry, the technology has clearly been validated. With an ever-increasing presence in the clinical setting, we are beginning to see increasing clinical research results linking Masimo SET pulse oximetry to positive, outcome-based findings. Drs Sola, Wright and Chow demonstrated a reduction in infant eye injury (ROP) following the implementation of a strict oxygen management protocol prescribing the use of Masimo SET pulse oximetry ["Can Changes in Clinical Practice Decrease the Incidence of Retinopathy of Prematurity in Very Low Birth Weight Infants?" PEDIATRICS (Vol.111 No. 2 February 2003)]. These case studies also show improvements in outcomes - the qualification of patients for CPAP and the reduction in operational costs - and that's what it's really all about; implementing the technological advantages of Masimo SET pulse oximetry to improve patient outcomes and reduce the cost of care."

Three Southern Californians Receive "ABBY" Award Recognizing Top Healthcare Innovators

Orange, CA (June 20, 2003). Joe Kiani, CEO of Masimo Corporation (in Irvine), Jay Short, Ph.D., CEO of Diversa Corporation (in San Diego) and Adam Singer, M.D., CEO of IPC-The Hospitalist Company (in North Hollywood), respectively took home the Platinum, Gold and Silver "ABBY" Awards at the Adaptive Business Leaders (ABL) Organization's Fifth Annual Innovations in HealthcareSM Awards and Event, held Wednesday, June 18, at the Hyatt Regency, Irvine. 

The three innovators were selected to receive the gold statuette from among a group of nine Innovations in HealthcareSM finalists for their outstanding advancements to the field of healthcare in medical technology, bio technology and information technology-enhanced healthcare services. According to Mimi Grant, President of ABL, "the 60-plus 'judges,' primarily ABL Members and other healthcare industry CEO's and Division heads attending the Event, found their greatest challenge of the day was selecting just three companies to win the 'ABBY' among the nine finalists, each of whom presented a compelling case as to why and how their product or service significantly advanced the quality of patient life or enabled the business of healthcare to be conducted more cost effectively." 

ABL's Technology Advisory Board selected the nine finalists from an impressive array of companies and organizations nominated by ABL Members and friends of the organization in April and May.

Joe Kiani, CEO of Masimo Corporation, took home the Platinum "ABBY." Masimo has developed proprietary signal processing and sensor technologies for cost-effective, noninvasive patient monitoring, improving patient outcomes and reducing the cost of care through its Masimo SET Pulse Oximetry technology. Joe has also brought leadership to the medical technology industry by breaking through the often bureaucratic hurdles established by some large healthcare systems and Group Purchasing Organizations.

Jay Short, Ph.D., CEO of Diversa Corporation received the Gold Innovations in HealthcareSM Award. Diversa is a leader in the discovery, evolution, and production of commercially valuable molecules with pharmaceutical applications, such as optimized monoclonal antibodies and orally active drugs. The company also developed a cutting edge technology that allows ultra high-throughput, resulting in faster new drug discovery, enabling the fast-tracking of the next cancer or autoimmune disease treatment development. 

Adam Singer, M.D. and CEO of IPC - The Hospitalist Company was awarded the Silver "ABBY." In 1991, IPC pioneered hospitalist care: full-time, acute primary care specialists who focus exclusively on patients receiving inpatient care. IPC-LINK^® is the company's proprietary clinical repository of best practices (and much more) that each of IPC's 400 physicians can easily access on their wireless hand-held computers, thus increasing economic efficiency while enhancing quality of care.

The other finalists included:
David Adamson, M.D., is Chairman and CEO of Advanced Reproductive Care, Inc, which is the only national organization of physician specialists in fertility care, who also have developed innovative payment plans. 

Eleanor Levin, M.D., is the Clinical Lead of Kaiser Permanente's Comprehensive Coronary Artery Disease Program, which has dramatically reduced the number of Kaiser patients suffering and dieing from coronary artery disease 

Bob Watson is President and CEO of Concuity, Inc., which provides an enterprise-wide information system that helps providers create and negotiate better contracts with payers and collect what's owed them. 

John O'Shaughnessy is President of Government Management Services, Inc., which created and operates FACIS^®, the Fraud and Abuse Control Information System, for verifying the credentials of, and reports sanctions against, physicians and other clinicians.

Ed Fotsch, M.D. is CEO of Medem, Inc., which, backed by the AMA, developed this physician-patient communications network to facilitate online access to information and care for more than 90,000 physicians and their patients.

Richard Brumley, M.D. is the Physician in Charge of Kaiser Permanente's TriCentral Palliative Care Program, which cares for those with serious, advanced, life-limiting illnesses and is focused on their quality of life. 

About the ABL Organization
From its inception, 20 years ago, the purpose of the Adaptive Business Leaders Organization (ABL; originally named SO/CAL/TEN) has been the sharing of best practices and innovative approaches that propel business growth. Today the Organization facilitates nine monthly Round Tables (from San Diego to San Francisco) and holds special forums throughout the year -- like Innovations in HealthcareSM -- that enable its healthcare and technology Members to learn from each other. Further, for ABL's healthcare Members there is a particular focus on how to cost-effectively apply innovative approaches to delivering high quality healthcare.

Frost & Sullivan Honors Masimo for Setting Patient Monitoring Standard of Care

Masimo Honored for Making Pulse Oximetry a Reliable Clinical Tool

SAN JOSE, Calif., June 16 -- Frost & Sullivan today presented the 2003 New Standard of Care in Patient Monitoring Award to Masimo Corporation, a developer of advanced medical signal processing technologies instrumental in state-of-the-art noninvasive monitoring of patient vital signs, at the AMMI Conference in Long Beach, California. Masimo Corporation is the first recipient of this prestigious award.

Aroop Zutshi, Frost & Sullivan senior partner, presented the award to Joe E. Kiani, Chairman and CEO of Masimo Corporation, in recognition of its commitment to patient care, its successful pioneering and introduction of next-generation pulse oximetry technology, and its demonstrated improvement of patient monitoring. 

In 1996,1997, and 1998, Masimo introduced in Europe, Japan and the US respectively, its pioneering Signal Extraction Technology (Masimo SET^®) solution, the first motion-tolerant and low-perfusion monitoring device, into the pulse oximetry and patient monitoring markets. Initially blocked from selling its product to the US hospitals through group purchasing organizations (GPOs), Masimo went directly to leading medical professionals and had its product assessed and compared against the leading pulse oximeters of the day. 

These independent studies highly favored the Masimo SET solution, raising the awareness of improvements in the medical community and creating strong demand for this motion-tolerant technology among healthcare workers. Prior to Masimo SET pulse oximetry, pulse oximeters were fraught with false alarms. In fact, approximately 90% of the pulse oximeter alarms were false with conventional pulse oximetry. The dramatic reduction in the number of false alarms, and the improvement in detection of true alarms, was felt to significantly improve the caregiver's productivity as well as provide reliable continuous patient pulse oximetry data. 

Masimo's low-perfusion technology also enables doctors and healthcare workers to measure oxygenation levels in patients which were previously unable to be measured and regulated. Clinical studies had shown that over 10% of the time pulse oximeters failed to provide any measurement during surgery in the OR. Masimo SET changed all of that. As a result, new standards of care are now being offered to patients from infants to geriatrics. "The rapid adoption of Masimo SET technology, by both hospitals and major patient monitoring equipment manufacturers demonstrates the value that the market has placed on this significant technological advancement," says Katherine Shariq, Frost & Sullivan industry analyst. 

The Frost & Sullivan New Standard of Care in Patient Monitoring Award is given to a company that has successfully developed or introduced a new or advanced version of a patient monitoring component or device, which could potentially revolutionize or reinvigorate the market. Multiple advantages over existing monitoring components clearly establish that the technology used in the field has evolved into a next-generation device. 

About Frost & Sullivan 
Founded in 1961, Frost & Sullivan, a global leader in growth consulting, presents Market Engineering Awards to companies that demonstrate excellence in their industry, commending the diligence and innovative business strategies required to advance in the global marketplace. Frost & Sullivan rigorously analyzes specific criteria to determine Market Engineering Award recipients in a vast variety of market industries and landscapes. For further information, visit www.frost.com

Prominent Researchers Present At Fourth World Congress On Pediatric Intensive Care Held In Boston

Boston, Massachusetts - June 10, 2003. A group of renowned researchers presented their research today at a symposium on oxygenation monitoring before a standing room only audience of over 300 clinicians at the Fourth World Federation on Pediatric and Intensive Critical Care Societies (WFPICCS) in Boston, Massachusetts. The conference, held every four years, is attended by the international community of doctors, nurses, and other pediatric care specialists. Dr. Geoffrey Barker, President of WFPICCS and Professor of Pediatrics, Anesthesiology and Critical Care Medicine, University of Toronto, introduced the symposium, "Advances in Oxygenation Monitoring for Pediatric Medicine," and moderated the follow-up discussion. The panel included Dr. Augusto Sola of Emory University, Dr. William Oliver of the Mayo Clinic, and Dr. Robert Brouillette of Montreal Children's Hospital. 

Dr. William Oliver, Jr., Associate professor, Co-Director Pediatric Cardiac ICU, Dept. of Anesthesiology, Mayo Clinic, Rochester, MN, presented the results of his study, "Pulse Oximetry for Patients Undergoing Congenital Heart Repair." Dr. Oliver pointed out that pulse oximetry has become integral to the perioperative treatment of infants during congenital heart repair surgery, but reliability, particularly during periods of low oxygen saturation, has always been a clinical concern. Dr. Oliver's study included a comparative device trial of three "state of the art" pulse oximeters - Masimo SET, Nellcor N-395, and Philips CMS B.0. Dr. Oliver used the Bland-Altman plots to show the agreement between oxygen saturation measured by pulse oximetry and by cooximetry. Dr. Oliver's study showed Masimo SET to be 44% more accurate than the Philips CMS and 13% more accurate than the Nellcor N-395 oximeter at saturations between 80% and 90%, and 53% and 24% more accurate than each unit, respectively, at saturations below 80%. 

Dr. Augusta Sola, Professor of Pediatrics, Director Neonatology, Emory University, Atlanta, GA, reported on a five-year study aimed at reducing the incidence of retinopathy of prematurity (ROP) through a strict oxygen management protocol that included the use of Masimo SET pulse oximetry. Dr. Sola pointed out that the incidence of ROP, which afflicts about 10% of premature babies in the neonatal intensive care unit, has been rising worldwide in recent years. He emphasized the need to neither over-oxygenate or under-oxygenate these pre-term infants, and that a pulse oximeter that reliably monitors the slight rises and falls of an infant's arterial oxygen saturation could provide clinicians with enough information to accurately oxygenate the baby and successfully avoid hypoxia, which can lead to brain damage, hyperoxemia, and ROP. Five years following the implementation of the new protocol at Cedars Sinai Medical Center with the Masimo SET pulse oximeter prescribed, Dr. Sola reported that the incidence of ROP stages 3 to 4 for all infants decreased from 12.5% to 2.5% between 1997 and 2001, while the national average remained approximately at the 12% range. Even more impressive was the reduction of ROP for infants with birth weight between 750 and 1249 grams from between 12 - 15% before the protocol to 0% five years later. Dr. Sola stated, "With caring clinicians utilizing Masimo SET technology, the need for surgery relating to retinal scarring or blindness from ROP had all but disappeared."

Dr. Robert Brouillette, Professor and Vice Chairman, Dept. of Pediatrics, The Montreal Children's Hospital, Monteal, Quebec, presented his study on the predictive value and the reliability of pulse oximetry in sleep lab tests of children potentially suffering from obstructive sleep apnea (OSA) - a condition that affects an estimated 1% of children. Although pulse oximetry has been considered a key element in polysomnography, researchers have questioned its ability to detect very brief epochs of desaturation. These brief epochs, however, define hypopneas and many apneas, and are crucial to establishing diagnoses, to measuring the success of treatment and, in the United States, to qualify for CPAP treatment under the new Medicare guidelines. Dr. Brouillette ran a comparative device trial of the Masimo SET Radical and the Nellcor N-395 and its predecessor, the N-200. Dr. Brouillette reported that the Masimo SET pulse oximeter captured 99% of the true hypopnea events, while the Nellcor N-395 and N-200 captured just 45% and 76% of true hypopnea events, respectively. Conversely, the N-395 was 2.4 times more likely than the Masimo SET oximeter to report false alarms during patient movement.

Dr. Geoffrey Barker stated, "I am proud to have been the moderator of such a topic and to interact with these esteemed researchers. Many years ago we set out to identify the safest patient monitoring modalities for our patients at the Hospital for Sick Children (HSC). We realized, while networking and information systems were important tools in communicating the health of our patients to our clinicians, nothing compared to clinical data that you can trust. We understood that without good data, you basically had a 'Garbage in, Garbage out' scenario. The results of these researchers are remarkable, and also reflect our experience in evaluating the Masimo SET oximeter at HSC. Masimo has truly made the pulse oximeter a useful clinical tool. As Dr. Sola has shown, there is now evidence that with such a tool, patient outcomes can be improved. Such a dramatic reduction in ROP is impressive and very powerful. We look forward to seeing more beneficial outcomes as a result of this technology reaching the hands of clinicians around the world." 

Masimo Announces the Release of Masimo SET V4

San Antonio, Texas, May 21, 2003 - Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced the release of Masimo SET Version Four (V4.1) at the annual National Teaching Institute and Critical Care Exposition held in San Antonio, Texas. In addition to improving Masimo SET's unmatched sensitivity (the ability to detect true desaturation events) and specificity (the ability to not false alarm), the release of Masimo SET V4.1 also debuts an innovative advancement in probe off detection called APODT, or Adaptive Probe Off Detection technology. V4.1 also incorporates the features that have distinguished Masimo SET, including Perfusion Index (PI), Signal IQT, and FastSatT.

Based on Masimo's architecture, most, if not all, existing Masimo SET customers may upgrade to the latest Masimo technology, Masimo SET V4.1, without hardware change. Masimo SET V4 is forward and backward compatible with all production MS Boards, Radical, Rad-9, and Masimo SET LNOP and NR Sensors.

Mitch Goldstein, MD, Assistant Clinical Professor at University California, Irvine and Director of Research and Medical Student Education in the Department of Neonatology at Citrus Valley Medical Center, stated: Several months ago, we conducted side by side evaluations of Masimo SET V3 and the Tyco-Nellcor Oximax N595. The Masimo SET V3 clearly outperformed the N-595. Masimo SET even worked during an entire neonatal resuscitation. The Nellcor N595 failed to read at all. Based on our evaluation, we converted our Neonatal ICU to Masimo SET pulse oximetry. We have now tested Masimo SET V4. It even has better fidelity and alarm reliability." 

"Masimo SET V4 now has Adaptive Probe Off Detection Technology. The ability to not give readings when the probe comes off is very important in the NICU. In the past 12 years, I have witnessed many instances when the pulse oximeter probe comes off the patient in the NICU and alarms will not sound since the pulse oximeter's saturation and pulse rate values are within the alarm limits. I believe that Masimo's new probe off detection technology will essentially eliminate this problem. I also believe that the N-595 is unable to meet the new standards Masimo V4 sets for enhanced stability, performance in sensitivity and specificity, and pulse oximetry validation. The current JCAHO mandates on alarms, demands that alarms be adhered to. Masimo SET is the only pulse oximeter that meets JCAHO's Alarm requirement," continued, Dr. Mitch Goldstein.

Masimo has been clinically proven in more than 50 independent and objective studies to outperform conventional and other, "next generation," pulse oximeters, even under the most challenging patient conditions, such as motion and low perfusion. Masimo innovations have significantly improved the quality of true alarm detection, false alarm rejection, and pulse oximetry reliability, while reducing costly dependence upon unnecessary blood gases, oxygen usage, and over-utilization of adhesive sensors. In 2000, Masimo SET V3 introduced FastSat, an algorithm designed to track rapid changes in oxygen saturation and Signal IQ, an additional waveform that visually communicates the acquired signal quality and timing of the arterial pulse even as the plethysmograph becomes corrupted with motion. Independent and objective clinical and laboratory studies show Masimo SET V3 outperforms the latest pulse oximeter technologies, including the Tyco-Nellcor N595 Oximax and the N395 Oxismart XL (references available). Masimo SET V3 constituted the third major advancement to Signal Extraction Technology; V4 takes the performance of Masimo SET to yet a new level.

The new Masimo SET V4 improves the sensitivity and specificity of the V3, while the introduction of Adaptive Probe Off DetectionT technology reduces the possibility of false security. APODT is a powerful algorithm that minimizes the risk of measurement when a probe is off the patient. Studies of APOD in the most difficult situations (when a sensor attached to a subject was removed during monitoring) had incorrect reading rates of only 1%. The closest competing technology, Nellcor Oximax N-595, showed incorrect reading rates of 32%. 

Helen Edwards, manager of Patient Monitoring Practices Project at The Hospital for Sick Children, Toronto, ON stated: "We undertook a lengthy investigation into evolving pulse oximeter technology for our hospital, and determined that Masimo would best meet our needs. The release of V4 shows that Masimo is committed to continuously improve their products and we look forward to implementing its new features and enhancements."

"The response of the nurses to V4 at the NTI has been extremely positive," stated Kevin Mosher, President Americas-Masimo. "Many have commented that the performance of V3 was superior to any other pulse oximetry product available and they are both surprised and pleased to learn that with V4 we have made additional improvements to the industry leading pulse oximetry technology."

Joe E. Kiani, CEO of Masimo Corporation, stated: "JCAHO has mandated adherence to alarms. Some companies have focused on remotely reporting alarms, we have concentrated on improving the measurement of pulse oximetry and reliability of the alarms. With the introduction of Masimo SET technology, false alarms dropped by over 90%, while the detection of true alarms increased. Masimo SET V1 had sensitivity and specificity of 93% during motion and low perfusion, while the competitor's sensitivity and specificity was 50% - at best, the toss of a coin. With V2 and V3, we pushed the sensitivity and specificity higher. Masimo SET V4 elevates the reliability of pulse oximetry higher again by attacking compromising probe off data, while still reducing false alarms and further increasing true alarms. Masimo SET V4 pushes pulse oximetry sensitivity and specificity to 97%. The goal is and has always been 100%. Since V1, we have closed the gap by 60%. Although a 4% improvement over 7 years may seem small and, to some, a questionable R&D expense, it is a responsibility we feel we must fulfill, as only we can. After all, who wants their child or loved one to fall in that 4% statistical group whose cries for help will be neglected because an oximeter failed to warn a caring clinician? It is with this passion that we pursue, as our stated goal, the perfection of noninvasive monitoring and pulse oximetry technology."

ECRI Evaluates Masimo SET^® and Other Next-Generation Pulse Oximeters

Irvine, California, May 14, 2003. Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, announced today that its Masimo SET technology has been evaluated by ECRI, an independent non-profit health services research agency. The results of the evaluation have been published in ECRI's February 2003 issue of Health Devices. The article, entitled, "Next-Generation Pulse Oximetry," reports on an evaluation they conducted to compare the performance of five next-generation pulse oximeters to each other, and to conventional pulse oximetry. ECRI has informed Masimo that any clinicians interested in reading a copy of the February 2003, Volume 32, Number 2 issue, should check with their hospitals' biomedical engineering or materials management department, or order a copy directly from ECRI.

MedAssets HSCA and Masimo Announce Three-Year Agreement

Masimo Signal Extraction Pulse OximetryT to be Available to MedAssets HSCA Members

ST. LOUIS, MO and IRVINE, CA - May 7, 2003 - MedAssets HSCA, a leading provider of healthcare supply chain management and outsourced business services, and Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, today announced an agreement to provide Masimo SET^® (Signal Extraction Technology) to MedAssets HSCA's healthcare provider customers. The three-year contract is effective June 1, 2003. 

The agreement addresses a wide variety of user needs through Masimo's extensive line of single patient adhesive and reusable sensors, including its RadicalT Signal Extraction Pulse Oximeter, which can be used to standardize a hospital to Masimo SET performance. Radical features Masimo SET V3, which provides unprecedented sensitivity and specificity for pulse oximetry alarms, and incorporates unique features such as Signal IQT, FastSatT, and Perfusion Index. 

Signal IQ is used for signal identification and indicates the confidence in the measurement, even during motion, while FastSat is an algorithm designed to track rapid changes in oxygen saturation. The Perfusion Index enables the clinician to know the relative blood pulsation amplitude. A recent research team has found Masimo SET's Perfusion Index to be potentially useful in the diagnosis of the severity of the preterm infant and as an early screening tool for infants born with antenatal infection at the measurement site. 

"Masimo's mission has been to reduce the cost and improve the quality of patient care by taking reliable patient monitoring to new sites and applications," said Kevin Mosher, President, Masimo Americas. "MedAssets HSCA is a progressive buying organization whose customers include many of the leading healthcare providers throughout the country, and we are delighted with the opportunity to bring the value of Masimo SET pulse oximetry to its member hospitals." 

Masimo was awarded the contract as a result of MedAssets HSCA's innovative contracting process that opens the door to innovative medical technology. In late 2002, MedAssets HSCA and the Medical Device Manufacturing Association (MDMA) hosted a Joint Technology Forum, in which 12 small manufacturers presented their products and services to a select committee of MedAssets HSCA's members, including clinical experts, who in turn recommended actions to MedAssets HSCA. MedAssets HSCA contracted with Masimo as a result of this technology summit review, citing Masimo's established record of delivering high performance, yet cost-effective pulse oximetry solutions which work through the most challenging patient conditions. 

"Our unique selection process has given us tremendous confidence in our decision to contract with Masimo," said Rand Ballard, president of MedAssets supply chain and business services group. "We have acted on our members' recommendation. This is a great example of industry participants working together, to provide a venue for new technology review to ultimately improve patient care" stated Ballard. 

About MedAssets HSCA
MedAssets HSCA, headquartered in St. Louis, MO, is the third largest group purchasing organization in the country, serving more than 16,000 healthcare providers nationwide, with purchasing power approaching $7 billion in gross throughput. It is MedAssets HSCA's mission to be the market-leading, customer-oriented supply chain and contract services company, focused on maximizing the financial performance of healthcare institutions. For more information about MedAssets HSCA, or its parent company MedAssets Inc., contact Gary Johnson, vice president for marketing and marketing services at gjohnson@medassets.com. 

New Study Demonstrates That Masimo SET LNOP^® Pulse Oximetry Sensors Last Over Twice as Long as Tyco-Nellcor's

Irvine, California, April 28, 2003 - A new study entitled, "Longevity of Masimo and Nellcor Pulse Oximeter Sensors," has been published in the Journal of Perinatology (2003;23:133-135) by a group of researchers led by Thomas Erler, MD, Department of Pediatrics, Carl-Thiem-Kinikum in Cottbus, Germany, and the Department of Pediatrics and Neonatology, University Hospital Otto-von-Guericke in Magdeburg, Germany. The objective of the study was to investigate the longevity and cost impact of pulse oximetry sensors used in the monitoring of oxygenation with sick newborns. The study found that the Masimo SET LNOP Neo sensor lasted 2.3 times as long as the Nellcor N-25 sensor in the Neonatal Intensive Care Unit (NICU). 

A total of 835.5 patient days of monitoring were accumulated on 121 infants at two medical centers in Germany. The study showed that while the Nellcor N-25 sensors, operating with the N-395 pulse oximeter, lasted an average of 3.9 days, the Masimo SET LNOP Neo sensors lasted over twice as long with an average 9.1 days. The authors explained, "Sensor construction differs between manufacturers, with identified shortcomings being life of electrical components, loss of adhesive preventing appropriate emitter and detector alignment, and susceptibility to moisture with resultant bad odor. Particularly in a humidified incubator, PO [pulse oximetry] sensors are easily soiled and develop an unpleasant odor. The humidity also leads to less adhesion. Therefore the consumption of PO sensors increases in this setting and so do costs." They concluded, "If the useful life of sensors is increased, as shown in our results for Masimo technology, a remarkable savings in costs in the NICU can occur. Our results show a more than two-fold longevity of the Masimo sensors." 

"Masimo SET^® pulse oximetry has been widely demonstrated through over 60 independent and objective clinical studies to outperform both conventional and other 'next generation' pulse oximeters. A growing body of clinical literature confirms that, in addition to improving patient care, Masimo SET technology also contributes to a reduction in the cost of care. Studies such as this, and Dr. Charles Durbin's recently published article in Critical Care Medicine¹, demonstrate the positive impacts of Masimo SET pulse oximetry to sensor longevity and caregiver behavior, including the reduction of arterial blood gas draws and faster oxygen weaning." Stated Joe E. Kiani, Founder & CEO of Masimo. 

1 'More reliable oximetry reduces the frequency of Arterial Blood Gas analysis and hastens oxygen weaning following cardiac surgery: A prospective randomized trial of the clinical impact of a new technology,' (Critical Care Med. 2002;(30)8:1735-1740)

Siemens and Masimo Announce License and Distribution Agreement for Masimo LNOP^® Pulse Oximetry Sensors

Siemens' INFINITY patient monitors to ship standard with Masimo SpO2 sensors

DANVERS, Mass., April 20, 2003 - Siemens Medical Solutions USA, Inc. and Masimo Corporation today announced a license and distribution agreement for shipping Siemens INFINITY patient monitors standard with Masimo's LNOP^® Pulse Oximetry Sensors. Additionally, Siemens will make Masimo's sensors available to its installed customer base. 

The Siemens INFINITY Patient Monitoring System is a comprehensive patient information management solution that delivers data where and when it's needed. To help hospitals improve workflow, increase efficiency and lower costs, INFINITY takes a different approach to monitor design, patient transport, bedside ergonomics and workflow, and information management. Combined with Masimo's LNOP sensors, the INFINITY system passes one of Masimo's more rigorous motion protocols and carries the Masimo Noise Reduction^® (NR^®) certification.

"Masimo's LNOP sensors are well known for their exceptional accuracy and durability," says Bill Isenberg, Group Vice President, Electromedical Systems Division, Siemens. "Our monitors represent the leading edge in patient monitoring, so it's a natural fit to match them with Masimo's sensors, which are the most advanced SpO2 sensors available. We believe this combination will provide a more durable and higher performing solution for our customers."

"Siemens is one of the world's leading manufacturers of patient monitors, with a particularly strong position in the European market," says Joe Kiani, CEO, Masimo. "Masimo has invested a tremendous amount of time and resources into creating a broad line of state-of-the-art, high-performance sensors that embody the best signal-to-noise characteristics of any sensor in the market. We're pleased that Siemens has chosen our sensors for their INFINITY line of patient monitors." 

New Study Demonstrates the Superior Accuracy and Precision of Masimo SET^® Pulse Oximetry in the Most Challenging Patients; Those with Congenital Cardiac Lesions

Masimo SET outperforms Tyco-Nellcor N-395

Irvine, California, April 16, 2003 - A new study, "Accuracy and Precision of Masimo SET, Agilent Merlin, and Nellcor N-395 Pulse Oximeters In Patients Undergoing Cardiopulmonary Bypass for Congenital Heart Defects," has been published in the March 2003 issue of Anesthesia and Analgesia (2003;96,SCA135) by a group of researchers led by William C. Oliver Jr., MD from the Anesthesia Department of the Mayo Clinic, Rochester, Minnesota. The aim of the study was to compare the accuracy of three pulse oximeters with reported improved capabilities; Masimo SET, Philips/Agilent/HP Merlin and Tyco-Nellcor N-395. Masimo SET was 44% more accurate than the Philips/Agilent Merlin, and 13% more accurate than the Nellcor N-395 oximeter at saturations between 80% and 90%, and 53% and 24% more accurate than each unit respectively at saturations below 80%. 

The study was conducted on fifty-two patients with congenital heart disease requiring CPB surgery. The three pulse oximeters were attached to specified digits on a rotational basis to avoid bias, and a CO-Oximeter was used to determine arterial oxygen saturation (SaO2) to compare with SpO2 values at the following points: baseline (after induction), 10 minutes after protamine administration, sternal closure, 30 minutes after intensive care unit (ICU) arrival, and 30 minutes post-extubation. 

The researchers at Mayo Clinic concluded, "Findings demonstrate that the Masimo SET pulse oximeter has better precision than the Agilent [HP/Philips] and Nellcor oximeters when saturation is between 80% to 90% in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) for congenital heart defects." 

"Masimo SET pulse oximetry has been clinically shown to consistently outperform all other oximetry under the most challenging conditions, including motion, low perfusion and, as indicated with this study on patients with low arterial blood oxygen levels," stated Mike Petterson, Sr. Director of Clinical Research at Masimo.

Study Shines New Light on the Reliability of Pulse Oximetry Reflectance Sensors

New Nellcor Reflectance Sensors Fail to Give Reliable Readings on 25% of Patients in Test

Irvine, California, April 7, 2003 - A new study, "Comparison of a Reflective Forehead and Digit Transmission Sensor for Oximetry in Mechanically Ventilated Adults," has been published in the January 2003 issue of Critical Care Medicine (Crit Care Med 2003; 30(12) suppl. A91) by a group of researchers from the University of Cincinnati. The study, which compared the performance of the Tyco-Nellcor MaxFast reflectance sensor to the Nellcor OxiMax digit sensor in mechanically ventilated patients, was also presented at the 2003 Society for Critical Care Medicine in San Antonio, Texas.

The study was conducted on 20 trauma patients monitored with both the Nellcor MaxFast reflectance sensor and the Nellcor Max-A digit sensor with the Nellcor N595 OxiMax pulse oximeter. A total of 73 arterial blood gas-oximeter data pair samples were obtained. Analysis of the study reveals the MaxFast reflectance sensor failed to meet Nellcor's stated accuracy claims. In addition, the MaxFast reflectance sensor failed to give reliable readings on 5 of the 20, or 25%, of the patients in the test due to various reasons. The researchers eliminated data from 3 patients due to edema, and eliminated data from 2 patients with whom the MaxFast reflectance sensor failed to acquire a signal.

The poster presented by the researchers at SCCM stated: "Under normal circumstances the reflective forehead sensor appears to have no advantage over traditional digital transmission sensors." The poster additionally stated: "The current study suggests that reflective forehead sensors perform poorly in the presence of anasarca (edema) and are complicated by reverse trendelenberg and prone positioning." 

"Reflectance sensor technology has been around for over a decade," stated Mike Petterson, RRT, Sr. Director of Clinical Research at Masimo. "These types of sensors have been plagued with problems since their first introduction, and this study confirms these problems still exist even with new versions of reflectance sensors."

New Research Shows Masimo SET's Perfusion Index Potentially Useful in the Diagnosis of the Severity of the Preterm Infant and as an Early Screening Tool for Infants Born with Antenatal Infection

Snowbird, Utah, April 3, 2003 -In a presentation at the 20th annual High Frequency Ventilation meeting in Snowbird, Utah, Dr. Claudio De Felice discussed his latest research concerning Masimo SET's Perfusion Index (PI) in the diagnosis and monitoring of sick infants. Dr. De Felice and Dr. Giuseppe Latini have been conducting their research in the Neonatal Intensive Care Unit of the Le Scotte Hospital in Siena and the Pediatric Division of the Perrino Hospital in Brindisi, Italy. An initial study published in the European Journal of Pediatrics¹ concluded that Masimo Corporation's Perfusion Index (PI) was an accurate predictor of illness severity in high-risk neonates. Dr. De Felice's presentation included new data which demonstrates how PI was also found to be an accurate predictor of a perinatal inflammatory disease, technically referred to as chorioamnionits (CA), which is known to be associated with increased risk for mortality and/or long term brain damage.

"The use of Masimo SET Perfusion Index as a diagnostic tool appears to be a breakthrough in caring for high risk newborns," stated Dr. De Felice. "Pulse oximetry has been an important tool in caring for newborns for the last 20 years, but we are just now starting to realize the increased usefulness of this parameter with the recent advancements made by Masimo." 

In a prospective study, 45 term newborns with histologically documented chorioamnionitis (CA), infection before birth, were compared to a control group of 45 term newborns without CA. A large fraction of CA remains subclinical, with no recognizable predictive clinical signs at birth being known to date. For both groups, Perfusion Index was assessed with the Masimo SET Radical immediately after birth for measurements at 1 minute and 5 minutes. The PI measurements and standard Apgar scores at the 1 minute and 5 minutes time markers were compared between the two groups. The PI at the 1 minute and 5 minutes time marker were statistically different between the groups (p value < 0.0001). In addition, there was statistical difference between the groups for the 1-min Apgar score (p value < 0.0001). On the other hand, birth weight, 5 min Apgar score, 1-min and 5-min SpO2, 1-min and 5-min pulse rate, 1-min and 5-min skin temperature, as well as 1-min and 5-min core temperature were not significantly different between the two groups. 

The data from this study suggests the use of Masimo SET Perfusion Index in monitoring of infants in the delivery room for the early screening of neonatal infections. Dr. De Felice stated, "The capability of reading Perfusion Index at low perfusion is now made possible by the accuracy and reliability of the Masimo SET Radical. In the past, our conventional pulse oximeters were not reliable or recommended for use in infants during low perfusion. It is important to note that an early CA / antenatal infection diagnosis by measuring low PI may make it possible to improve the outcome of affected neonates. This new capability of working in difficult and very extreme situations (high risk deliveries) and giving us reliable oxygen saturation, pulse rate and PI data has aided us in our clinical practice and is expected to lead to better neonatal outcomes."

1. De Felice et al. The pulse oximeter perfusion index as a predictor for high illness severity in neonates. 
Eur J Pediatr 2002 ; 161 :561-562.

LeeSar Healthcare System Converts to Masimo SET^® Pulse Oximetry

System finds Masimo SET superior in clinical evaluation of "next generation" pulse oximeters

Irvine, California, March 17, 2003. Masimo, the innovator of Signal Extraction Pulse Oximetry, announced today that the LeeSar Healthcare system has standardized on Masimo SET pulse oximetry. Their system-wide conversion follows an extensive evaluation of Masimo SET and other "next generation" pulse oximeters in which they concluded Masimo SET offered superior clinical performance with lower operational costs. 

"The pulse oximetry evaluation at the 4 hospitals which make up the LeeSar System was quite extensive, including an in depth clinical comparison of both Masimo's and Nellcor's latest pulse oximetry offerings, as well as an analysis of the overall cost of ownership for both systems. The clinicians ultimately concluded the performance of Masimo SET was much better than the other oximeters they evaluated," said Bill Towsey, Director of Materials Management for the LeeSar system. "Due to the design and durability of Masimo's LNOP sensors, we are anxious to realize the cost savings of the new technology for the hospital system by switching to Masimo SET pulse oximetry."

"Our clinical evaluation of Masimo's and Nellcor's new generation pulse oximetry technologies was very comprehensive, involving data collection and analysis of data from patients at our hospital," stated Diane Sobel Director of Respiratory Therapy, for Cape Coral Hospital. "We wanted to be certain the comparison was completely objective, so we insisted on analyzing the data ourselves. Not only did the Masimo SET oximeter outperform Nellcor's Oxismart XL, but we concluded the differences were clinically significant."

"The LeeSar system is a world-class network of hospitals that represents the best in patient care," stated Kevin Mosher, President, Americas for Masimo Corporation. "LeeSar undertook an extensive evaluation of Masimo SET versus Tyco-Nellcor's 'next generation' pulse oximetry technology, and we are delighted to see their conclusions are consistent with the large volume of clinical and laboratory studies that demonstrate the superior performance of Masimo SET pulse oximetry."

Masimo Introduces MS-11 Very Low Power Signal Extraction Pulse OximetryT OEM Board

Irvine, California, March 5, 2003 - Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, announced today that it has completed development and testing of a new very low power and low profile pulse oximetry printed circuit board. The MS-11 utilizes approximately 125 mW, roughly one-half the power of the MS-7T board and one sixteenth of the power of Masimo's first OEM printed circuit board, the MS-1T.

The MS-1, MS-3, MS-5, MS-7 and MS-11 boards carry the full Masimo SET signal processing algorithm and are sold to Masimo's licensees for incorporation to their patient monitors and therapeutic devices. Once integrated, these instruments then give Masimo SET performance with any of the full line of Masimo single patient adhesive or reusable sensors. To date, Masimo has licensed its Signal Extraction pulse oximetry technology to over 35 patient monitoring companies, representing over 60% of the pulse oximetry market. Measuring the size of a business card, the MS-11 allows the revolutionary motion and low perfusion performance of Masimo SET to now be available in battery operated and handheld devices. 

Joe E. Kiani, Chairman and CEO of Masimo Corporation stated, "I am extremely proud of our engineering team. They keep raising the bar for the betterment of patient care. MS-11 will usher a new line of monitors for ambulatory patients where reliability, sensitivity and specificity are not sacrificed for battery life or size. Ambulatory patients at risk of respiratory or cardiovascular disorder are better served when monitored with a technology that can actually work during motion. MS-11 with Masimo SET technology can measure pulse rate and arterial oxygen saturation with unprecedented reliability and accuracy, even under motion and low perfusion conditions and still meet the battery life needs of hospitals."

New Study Links Reduction in Retinopathy of Prematurity (ROP) to Strict Management of Oxygen Delivery and Monitoring

Study cites ease in following policy due to less artifact and fewer false alarms with Masimo SET^® pulse oximetry

Irvine, California, February 12, 2003 - A new study, "Can Changes in Clinical Practice Decrease the Incidence of Retinopathy of Prematurity in Very Low Birth Weight Infants?", has been published in the February 2003 issue of PEDIATRICS (Vol.111 No. 2 February 2003). The senior author is Augusto Sola, MD, Division of Neonatal-Perinatal Medicine, Emory University, Atlanta, Georgia; other authors are Lily C. Chow, MD, Kenneth W. Wright, MD, Division of Neonatology, Department of Pediatrics, Cedars Sinai Medical Center and the UCLA School of Medicine, Los Angeles, California. The study's objective was to compare the incidence of and need for surgery for severe ROP (infant eye damage - stages ≥ 3) in Very Low Birth Weight (VLBW) infants before and after implementation of a new clinical practice of oxygen management. The incidence of ROP, stage 3 to 4, decreased consistently in a 5-year period from 12.5% in 1997 to 2.5% in 2001. The need for ROP laser treatment decreased from 4.5% to 0% in the last 3 years. 

The study, conducted on approximately 445 infants (86 - 92 per year) over a five-year period, compared patient outcomes to both the period prior to the implementation of a policy for the management of inspired oxygen (FiO2) and oxygen saturation monitors in VLBW infants, and to data collected over the same period by the Vermont Oxford Network (VON), a non-profit voluntary collaboration of over 400 Neonatal Intensive Care Units (NICUs) in North America, Europe, the Middle East, Asia and the Pacific Rim. The authors' commented, "The main objectives [of the oxygen management policy] were to monitor oxygenation levels more precisely to attempt to decrease the numbers of "false alarms" and to avoid hyperoxia [over-oxygenation] and repeated episodes of hypoxia-hyperoxia in VLBW infants. Included in the policy was new equipment for monitoring SpO2 to measure more accurately arterial blood oxygen and saturation levels and pulse rates in the presence of the infant's movement and low perfusion (Masimo Radical Signal Extraction Technology Pulse Oximeter, Irvine, CA)." All personnel were required to sign the policy stating understanding of and compliance with the guidelines. 

After the O2 policy implementation in 1998, the incidence of ROP stages 3 to 4 for all infants decreased from 12.5% to 2.5% between 1997 and 2001. The global incidence of severe ROP reported by the VON for the same period did not change significantly, remaining between approximately 10 - 12% for all categories of birth weight. A table showing the incidence of severe ROP by birth weight category is shown in the following table:

The study's authors concluded, "As part of an organized process of improvement in quality of care, the implementation of a clinical practice change of curtailed O2 was associated with an important and clinically significant decrease in the incidence of both severe ROP and the need for ROP therapy. We can speculate that the decrease in incidence of ROP was "gradual" because the change in practice was gradual, as a result of the time that it took for the "buy in" of all bedside nurses and RTs to deliver the practice at all times for all infants. In addition, many care providers reported greater ease in following the policy with the use of new SpO2 monitors (Masimo Signal Extraction Technology) with less artifact and fewer false alarms." 

Joe E. Kiani, Chief Executive Officer of Masimo stated, "This is a ground breaking study. This is the first time that such a dramatic reduction of ROP has been reported. This improvement in care and dramatic reduction in morbidity was made possible by the researchers creating a sound clinical protocol and the clinicians' vigilant adherence to the protocol for the care of premature babies in the neonatal intensive care unit. Various studies have demonstrated that improved patient outcomes can occur when positive changes in caregiver practices are combined with superior clinical tools. Many of these studies have demonstrated that Masimo SET pulse oximetry can assist in faster weaning times, less O2 administration, fewer Arterial Blood Gasses (ABGs) and better clinical intervention based upon more accurate and reliable SpO2 monitoring. Masimo SET pulse oximetry is the best pulse oximeter available today, but at the end it's only a tool, which can be valuable when used by caring and proficient clinicians with sound protocol. The fact that Masimo SET was a key component to the oxygen management protocol implemented by this group of clinicians is flattering, but it is their results - the improved quality of life for these babies - that makes the efforts of both the clinicians and our company worthwhile."

Masimo Announces New & Improved Low Noise Optical Probe^® Neonatal Sensor with Innovative Bridge Design

Sensors offer LNOP^® performance with unmatched ease of application & flexibility

Irvine, California, February 5, 2003. Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, today announced the launch of its second generation Low Noise Optical Probe Neonatal Y (LNOP Neo) sensor with innovative bridge design. The new bridge design improves ease of application, while providing the clinician with maximum flexibility in sensor placement for neonates of all sizes. The new LNOP Neo adhesive sensor incorporates low noise sensor technology, which was pioneered by Masimo.

The new LNOP Neo design offers a "bridge" connection between the Y bands of the emitter and photo detector, thereby enabling the clinician to single-handedly attach the sensor. For wider application sites, such as neonates with large feet, the clinician can simply tear the perforated bridge connection, allowing for wider separation of the emitter and photo detector to accommodate the site. LNOP sensors are the first single patient adhesive pulse oximetry sensors designed to last throughout the patient's stay, making Masimo SET LNOP sensors the most reliable and cost effective sensors in the market. 

"There are many subtle and powerful design features in the LNOP sensors that provide improved performance during motion, low perfusion and other low signal to noise conditions," said Joe E. Kiani, Chairman and CEO of Masimo. "The addition of the bridge to our Neo Y sensor comes as a result of feedback from the many clinicians who use and value the performance of Masimo SET pulse oximetry; we believe this innovative sensor design will provide a new dimension of flexibility in using pulse oximetry sensors."

New Study Published in Anesthesia & Analgesia Demonstrates Superiority of Masimo SET^® Pulse Oximetry during Cardiopulmonary Bypass

Irvine, California, January 30, 2003 - A team of researchers, led by Kazuo Irita, MD, PhD, from Kyushu University in Fukuoka, Japan published the results of their study entitled, "Performance Evaluation of a New Pulse Oximeter During Mild Hypothermic Cardiopulmonary Bypass" in this month's issue of Anesthesia and Analgesia. The study showed the mean time of accurate operation to be 10 times greater with the Masimo SET pulse oximeter compared to the competitor.

Dr. Irita's team of researchers studied the pulse oximeter failure rate, defined as no SpO2 reading and/or an inaccurate SpO2 reading, in adult patients during Cardiopulmonary Bypass (CPB). They found statistically significant differences between the pulse oximeter technologies in their ability to accurately measure during CPB. In addition, the researchers found that pulse oximeter failure occurred often in patients with preoperative diuretic therapy or intraoperative hyperlactatemia with the competitive pulse oximeter, but not with the Masimo SET pulse oximeter. Both of these subsets of patients were at risk for systemic hypoperfusion. Overall, these researchers found the Masimo SET technology "to be more useful for monitoring SpO2 during hypoperfusion."

Joe E. Kiani, Chief Executive Officer of Masimo stated, "The results reported by Dr. Irita and his fellow researchers further add to the growing body of research that demonstrates Masimo SET's ability to continue to operate even in the most difficult of clinical situations. This study, by these distinguished researchers, points out the ability of Masimo SET pulse oximetry to accurately operate during minimal peripheral perfusion, a situation that often occurs unexpectedly in the clinical setting." 

"Masimo SET is known for its unprecedented performance during motion," stated Kevin Mosher, President, Masimo Americas. "Now independent clinical research is also showing the Masimo SET technology to be equally as effective in dealing with low perfusion. Dr. Irita's and his fellow researchers' new study adds to the peer reviewed, independent and objective studies that demonstrate Masimo SET's advantage over other pulse oximeters."

Masimo Announces RadT9 Signal Extraction^® Pulse Oximeter

Latest Masimo oximeter offers conventional enclosure design with the Masimo SET^® Engine

Irvine, California, January 21, 2003. Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, today announced the release of Rad-9, its first conventional enclosure design featuring the performance and accuracy of Masimo SET technology. Rad-9, designed to compliment Masimo's Radical pulse oximeter, is an ideal solution for true standalone bedside pulse oximetry uses where the rich features of Radical^®, including flexibility, ease of transport, or SatShareT (ability to convert a multiparameter pulse oximeter to Masimo SET) are not a requirement. 

The Rad-9 pulse oximeter features a user-friendly set up menu and a high visibility graphic blue display. Rad-9 is compatible with all Masimo LNOP^® and NRT sensors and offers a full range of features, including Masimo's proprietary Signal IQT waveform for signal identification and quality indication during motion and low signal-to-noise situations. Rad-9 also offers Perfusion Index (PI) indicator, which has been recently reported to potentially provide diagnostic information regarding the patient . PI and Signal IQ can also assist the clinician in identifying an optimum sensor placement location.

"Rad-9 allows all clinicians to have access to the best and safest pulse oximeter, even those who thought they couldn't afford the performance of Masimo SET," said Joe E. Kiani, Chairman and CEO of Masimo.
"The Rad-9 is a perfect compliment to the Radical pulse oximeter," stated Kevin Mosher, President Masimo Americas. "Combined, the two pulse oximeters offer hospitals with a flexible, economically attractive solution for standardizing on the new gold standard in pulse oximetry, Masimo SET." 

First Independent Study Comparing Masimo SET^® to Tyco-Nellcor N595 Presented at Society for Technology in Anesthesia

Masimo SET provides significantly higher sensitivity, specificity and reliability than the N-595

San Diego, California, January 13, 2003 - A new study was presented last week at the annual Society for Technology in Anesthesia by Steven J. Barker, PhD, MD, Department of Anesthesiology, University of Arizona, Tucson, Arizona. The study compared the performance of the Masimo SET V3 RadicalT to Tyco-Nellcor's N-395 and N-595 (Oximax), under conditions of motion, low perfusion and hypoxemia in human volunteers. The researchers reported that Masimo SET pulse oximeter exhibited the best overall performance with 96% sensitivity (ability to detect true events) and 100% specificity (ability to reject false alarms) compared to 75% and 86%, respectively for the N-595 Oximax. The Masimo SET oximeter also experienced no pulse rate failures, while the Nellcor Oximax failed to display accurate pulse rate 6.2% of the time. The results are shown in the following table:

Dr. Barker concluded, "Nellcor has recently released the N595 pulse oximeter as an improvement in performance over their N-395. In our standardized motion/hypoxemia protocol, we did not find N-595 performance to be better than that of N-395. The Masimo SET Radical performed significantly better than either Nellcor models." 

Kevin Mosher, President Americas stated; "Dr. Barker's volunteer motion and low perfusion protocol is the only protocol that has produced results that have correlated closely with how pulse oximeters perform in the real clinical environment¹. While Masimo SET continues to dramatically outperform both systems, it is puzzling that the N-595 Oximax seems to offer no performance advantages over the N-395. We can only surmise that the release of Oximax, which requires a new, proprietary sensor from Nellcor, is part of an overall strategy to neutralize the efforts from manufacturers of Nellcor generic sensors to sell into their installed base when the patents on their current sensors expire later this year."

Joe E. Kiani, Chief Executive Officer of Masimo stated, "Dr. Barker is one of the most respected authorities in the field of Anesthesia and oxygen monitoring. In 1991 we went to Dr. Barker to show him the prototype of our SET technology and to see if he and his colleagues would test our assertion that we had solved the problems of motion artifact and low perfusion. We went to him because he had proven his objectivity and credibility not only with dozens of research publications but also with his negative study results on the very first reflectance pulse oximeter sensor, manufactured by Sentinel and distributed by Ciba Corning, proving that he served his colleagues and not industry." 

About Steven J. Barker, MD, Ph.D. 
Dr. Steven Barker obtained his B.S. in Physics (1967) from Harvey Mudd College, followed by M.S. (1968) and Ph.D. (1972) in Engineering Science from the California Institute of Technology, with research in fluid mechanics and aeronautical engineering. After a postdoctoral fellowship at Caltech, he joined the faculty of Mechanics and Structures at UCLA in 1974. He was promoted to Associate Professor of Engineering, with tenure, in 1978. He obtained his M.D. from the University of Miami School of Medicine in 1981. After an internship in general surgery, Dr. Barker served his residency in anesthesiology at the University of California, San Diego. In 1984, Dr. Barker joined the faculty of the Department of Anesthesiology at the University of California, Irvine, where he was promoted to the rank of Associate Professor in 1986 and Professor in 1992. Dr. Barker served as Chairman of Anesthesiology at UC Irvine from 1990 until 1995. In September 1995, Dr. Barker joined the Department of Anesthesiology at the University of Arizona College of Medicine as Professor and Department Head. He also holds a joint appointment as Professor of Mechanical and Aerospace Engineering. Dr. Barker has been elected as chairman of the council of clinical department heads at the University of Arizona (2000-2003). Nationally, he serves as the President of the Association of Anesthesia Program Directors (2001-2003), and Secretary of the Association of University Anesthesiologists. He served as President of the Society for Technology in Anesthesia (1998-99). Dr. Barker is an oral examiner for the American Board of Anesthesiology, and is the Section Editor for Technology, Computing, and Simulation in the journal Anesthesia and Analgesia. Dr. Barker has published 100 scholarly works including 15 book chapters. His recent research is in oxygen transport and monitoring (particularly pulse oximetry), continuous intravascular monitoring, brain function monitoring, and the physics of airway flows and ventilation.

1. Torres A, Skender K, Wohrley J, Aldag J, Raff G, Geiss D, Assessment of 2 New Generation Pulse Oximeters During Low Perfusion in Children. Crit Care Med Vol. 29 No. 12 (Suppl.) A117 Dec 2001
Additional References:
Brouillette RT, Lavergne J, Leimanis A, Nixon GM, Laden S, McGregor CD. Differences in pulse oximetry technology can affect detection of sleep disorders in children. Anesthesia and Analgesia 2002; 94(S1): S47-53.
Bohnhorst B, Peter CS, Poets CF. Pulse oximeters' reliability in detecting hypoxemia and bradycardia: Comparison between a conventional and two new generation oximeters. Critical Care Medicine 2000; 28(5): 1565-1568.
Hay WW, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients, Journal of Perinatology, Vol.22, No. 5, July/August 2002.
Miyasaka K. Pulse oximetry in the management of children in the PICU. Anesthesia and Analgesia 2002; 94(S1): S44-46.
Shah N, Hoang TD Clack SL, Anderson CT. The impact of motion and low perfusion on the performance of Masimo SET pulse oximeter (PO) and four other POs for measurement of oxygen saturation (SpO2) and pulse rate (PR) in human volunteers. Anesthesiology 2001;95:A553.
Trang H, Leske V, Boureghda S, Gaultier C. Masimo SET pulse oximetry improves detection of sleep apnea- related hypoxemia. American Journal of Respiratory and Critical Care Medicine 2001;163(5):A298.
Lichtenthal P, Barker SJ. An Evaluation of Pulse Oximetry - Pre, during and Post CardioPulmonary Bypass. Abstract Presented at the 2002 American Society of Anesthesiologists, October 2002.

Masimo Corporation Presents at JP Morgan H&Q Healthcare Conference

Masimo Reports Record Results for 2002 and First Profitable Year

SAN FRANCISCO, Jan. 8, 2003-- Masimo Corporation today presented at the 21st Annual JP Morgan H&Q Healthcare Conference held in San Francisco. Masimo, a privately-held medical technology company, is the innovator of breakthrough signal processing and sensor technology for patient monitoring and the market leader of motion and low perfusion tolerant pulse oximetry.

Joe E. Kiani, Chairman and CEO, reported that the Company continued to make solid progress in 2002. Mr. Kiani stated that the Company's revenues nearly doubled to over $40 million and that the worldwide installed base of monitors using Masimo SET^® pulse oximetry had grown by more than 60% to over 100,000 units by year-end. This growth in the installed base helped Masimo to nearly double its sensor shipments for 2002. Mr. Kiani also reported that the Company had reached profitability earlier in the year and expected to report net profit for the year ended December 31, 2002.

"I want to thank our loyal customers and dedicated Team for making Masimo one of the fastest growing medical technology companies in the world," stated Joe E. Kiani, Chairman and CEO of Masimo. "Since our commercial operations began in 1997, we have averaged annual compounded growth of over 100% due to the market demand for our motion and low perfusion tolerant pulse oximeters. We believe this growth, although impressive, is artificially lower than it should be due to the anticompetitive practices of Tyco-Nellcor. They have exerted pressure on hospitals, purchasing groups and our OEM partners to prevent the adoption of our technology and, although some were influenced, others ignored them and purchased our products anyway. I am hopeful that the current trends will continue so that more hospitals will be able to select the best products for the right reasons, for the benefit of their patients."