Press Releases - 2000
ECRI Evaluates Masimo SET Pulse Oximetry
Irvine, California, November 1, 2000 - 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 in ECRI’s October 2000 issue of Health Devices. ECRI's evaluation article is entitled, "Next-Generation Pulse Oximetry: Focusing on Masimo SET". ECRI has informed Masimo that any clinician interested in reading a copy of the October 2000, Volume 29, Number 10 issue, should check with their hospitals' biomedical engineering or materials management department or order a copy directly from ECRI.
“The ECRI Health Devices Journal is the “consumer report” of the medical industry. Thousands of hospitals subscribe to ECRI to get an independent evaluation of available technologies. The last time ECRI did evaluations on pulse oximetry was more than 10 years ago, we are happy to see that ECRI has taken the time to evaluate Masimo SET pulse oximetry”, stated Joe E. Kiani, President & CEO of Masimo Corporation.
Hill-Rom, Inc., A Hillenbrand Industries Company, and Masimo Corporation Form a New Strategic Alliance
Advanced Monitoring Technology to Complement Hill-Rom's Wide Array of Products
BATESVILLE, Ind., Oct. 26 -- Hill-Rom, Inc., a Hillenbrand Industries Inc. company, announced today a new partnership with Masimo Corporation, Irvine, Calif., that will unite the best healthcare solutions provider with the most advanced pulse oximetry technology available. Under the terms of the agreement, Hill-Rom intends to make Masimo SET its preferred pulse oximetry platform available in various Hill-Rom product offerings.
Hill-Rom will explore adding Masimo SET pulse oximetry to a number of products based on the needs of Hill-Rom customers. The company intends to seek new markets with Masimo's technology, aimed at increasing the value and scope of quality healthcare.
"Hill-Rom's leadership position in creating innovative solutions for healthcare providers and Masimo's breakthrough technology are an excellent combination to complement the world's most advanced health care facilities," said Bob Tennison, Hill-Rom President and CEO. "Through this licensing agreement, we will develop products that provide immediate and convenient access for healthcare providers to accurately track physiology, even under the most difficult conditions."
Pulse oximetry is the noninvasive measurement of the amount of oxygen carried by a patient's arterial hemoglobin as well as pulse rate. Pulse oximetry, designated as SpO2, has been called "the fifth vital sign," after heart rate, blood pressure, temperature and respiration rate. By providing continuous confirmation of the adequacy of circulation and, on a heartbeat-by- heartbeat basis, confirmation that delivery of oxygen to bodily tissues is adequate, it has quickly become a standard of care for monitoring critically ill patients and all patients undergoing anesthesia.
"Masimo invented Signal Extraction Pulse Oximetry in 1989, and after years of clinical research launched it internationally in the late 90's," stated Joe E. Kiani, President and CEO of Masimo Corporation. "Monitoring patients with Masimo SET pulse oximetry has quickly become the new standard of care because it gives clinicians the capability to track their patient's physiology accurately, even under the most difficult conditions, when it's needed most. Given Hill-Rom's strong commitment to provide its customers with the best patient care solutions, care providers and patients can expect great things to come about as a result of our alliance. This agreement will produce innovative products for today's demanding healthcare environment."
Masimo SET Performance Improves Patient Care through Ten-Fold Reduction in Untrustworthy Alarms that Have Recently Been Linked to Human Error and Patient Safety Concerns
Clinical Study Awarded “Best ASA Abstract”at the American Society of Anesthesiologists Annual Meeting
Irvine, California, October 23, 2000 - Last week, at the American Society of Anesthesiologists (ASA) annual meeting, Charles G. Durbin, Jr. MD, FCCM, Professor of Anesthesiology at the University of Virginia, presented the results of the study conducted by him and his colleague, Stephanie K. Rostow, RRT at UVA, titled “Pulse Oximetry Performance Can Affect Caregiver Time Utilization.” (Anesthesiology 2000, A556). The Society for Technology in Anesthesia bestowed the award of “Best ASA Abstract” to this study on Tuesday morning.
This groundbreaking study evaluated the impact of Masimo SET pulse oximetry on the frequency of oximeter malfunction and potentially wasted caregiver time, which has led to patient safety concerns. The researchers stated: “Inaccurate, invalid, and incorrect pulse oximetry consumes caregivers time when they are forced to care for the monitor and not the patient. Recent interest in human error and patient safety has identified untrustworthy alarms and indicators as being one of many latent conditions leading to human error.”
Adult cardiac surgery patients in the intensive care unit were monitored by both a Masimo SET and a conventional pulse oximeter. Patients were then randomly assigned to have the display of either the Masimo SET or the conventional device available to the caregivers with the other device’s display blinded and alarms muted. The results showed a more than ten-fold increase in functional time for the Masimo SET device as compared to the conventional pulse oximeter.
Dr. Durbin concluded, “Increased non-functional monitoring time, which was significantly greater with the conventional device, resulted in caregivers needing to respond to the device failure, diverting them from patient care. Masimo SET pulse oximetry provides significantly less oximeter non-functional time than conventional pulse oximetry and reduces the number of untrustworthy alarms and indicators.”
“We congratulate Dr. Durbin and his colleague on their innovative research,” stated Joe E. Kiani, President and CEO of Masimo Corporation. “The fact that Dr. Durbin’s peers within the ASA and STA singled out this study as the most significant technology research presented at the conference, speaks to the positive impact that Masimo SET can have on clinical practice.”
Mr. Kiani continued: “This was one of eight studies presented at the ASA that compared all other pulse oximeters to Masimo SET. Masimo SET has become the benchmark to which all other pulse oximeters are compared. But, what makes us proud is that two of these studies were done by the most prominent researchers in the field. Dr. Durbin is known by his peers as being one of the most reputable and independent researchers in the country. The same is true for Dr. Steven J. Barker, who, for the last three years, has been an invited ASA Refresher Course Lecturer. Neither of these researchers received compensation for their studies from Masimo. With some of the other research commissioned by the industry now surfacing, it is more important than ever to consider the source.”
Masimo SET Shown to be By Far the Most Accurate and Reliable Pulse Oximeter During Motion & Low Perfusion
San Francisco, California, October 17, 2000 – A leading anesthesiologist, Steven J. Barker, PhD, MD, Professor and Head of Anesthesiology at University of Arizona, this week presented his latest pulse oximetry research at the 2000 American Society of Anesthesiologists Annual Meeting in San Francisco. Dr. Barker’s research concluded that Masimo SET was by far the most accurate and reliable pulse oximetry technology tested under difficult conditions of motion and low perfusion. The research was presented during the ASA Refresher Lecture Course titled “Recent Developments in Oxygen Monitoring.”
Dr. Barker, who has published more than 25 studies related to oxygen monitoring, presented data from the University of Arizona that are part of an exhaustive study which so far has compared 19 pulse oximeters to Masimo SET, on 70 subjects, during motion and low perfusion. The most recent data include all of the latest pulse oximeters that claim to beaccurate during motion and low perfusion. In terms of false alarm rejection, Masimo was the best at 97%, followed by the Agilent Viridia-24C at 90%, the Agilent CMS-Rev B at 83%, the Mallinckrodt Nellcor N395 at 73% and the Novametrix MARS at 42%. There was an even greater gap in performance in terms of the rate of true alarm detection, with Masimo SET at 99%, the Viridia-24C at 78%, the CMS-Rev. B and N395 at 70% and the MARS at 40%.
According to Dr. Barker, “This is how the latest products claiming accuracy during motion performed in our study. With the exception of Masimo, it appears that the other instruments have achieved fewer false alarms at the expense of missing true alarms. Clinicians should be aware of this fact before they decide to use these devices on their patients.”
Dr. Barker also commented on the recent results from the Nellcor sponsored studies. In an effort to clear up the confusion resulting from the studies authored by Dr. Jopling and Drs. Gehring and Hornberger, Dr. Barker publicly invited these researchers to conduct a joint study at the University of Arizona, and suggested that they work together on the protocol for this joint study. “I have not yet received a firm response to my request, but I am hopeful that we can do this for the benefit of all of our colleagues.”
Irvine, California, October 15, 2000 – Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry today issued a $250,000 (USD) guarantee that Masimo SET will outperform all other pulse oximeters. This offer is available only to hospitals whose goal it is to upgrade their pulse oximetry hospital-wide to the new standard. Important details, conditions and qualifications for the guarantee are available on our web page: http://www.masimo.com.
“Recently there has been too much noise in the industry by other companies claiming to have developed motion and low perfusion pulse oximetry technology equivalent to Masimo SET,” stated Joe E. Kiani, President and CEO of Masimo. “Their claims have gone from one extreme to another regarding their performance compared to Masimo SET. But, we know and they know that they can’t match the performance of Masimo SET in an honest clinical evaluation. We hope this guarantee sends a clear message to clinicians, biomedical engineers and hospital administrators, who are interested in improving their pulse oximetry performance, to see through their marketing gimmicks.”
Mr. Kiani continued, “We understand that hospital conversions to a new technology and platform require time and effort. We are so confident in the performance superiority of our technology that we are willing to guarantee to those care providers that their time and efforts will not be wasted.”
Introducing FastSat™ and Signal IQ™ for Unprecedented Pulse Oximetry Fidelity
Irvine, California, October 12, 2000 – Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced the release of Masimo SET, Version Three (V3). V3 will make its debut in live side-by-side demonstrations at the American Society of Anesthesiologists 2000 annual meeting in San Francisco (October 15-17th). With the release of Masimo SET V3, Masimo is also debuting FastSat, which for the first time allows pulse oximeters to accurately track rapid saturation changes with unprecedented fidelity while rejecting false alarms due to motion artifact and low perfusion. V3 also features Signal IQ, a unique visual indication, which displays the acquired signal quality and the timing of the arterial pulse even under motion and low perfusion.
Existing Masimo SET customers can take advantage of V3 without hardware change. Most Masimo SET products can get upgraded to V3 via software upgrade.
Masimo SET technology has been clinically proven, in more than 25 independent studies, to be the most accurate pulse oximetry under the most challenging conditions of motion and low perfusion and when it’s needed the most. These studies have shown significant improvements in false alarm rejection, true alarm detection, drop outs (failure to operate), and accuracy, as well as cost savings from fewer blood gases, decreased oxygen usage and improved sensor longevity. Masimo SET V1 was first introduced in 1997 in Europe and Japan. In 1998, after receiving clearance for accuracy during motion, Masimo SET V2 pulse oximeters were introduced in the US in patient monitoring products, such as the Datascope Passport. Masimo SET has undergone 6 years of testing in all of the toughest environments. The new Masimo SET V3 represents the third major advancement to Signal Extraction Technology, the original breakthrough technology designed specifically to provide accurate monitoring during motion and low perfusion.
In the most recent clinical study conducted at University of Arizona, Masimo SET V2, under continuous motion and low perfusion, has been shown to have an unprecedented sensitivity of 98% and specificity of 93%, a significant improvement over all other pulse oximeters, including the Mallinckrodt Nellcor N395, which had a sensitivity of 63% and specificity of 82%. With the introduction of Masimo SET V3, the performance clinicians have come to expect from Masimo SET pulse oximeters will increase as V3 further pushes the sensitivity and specificity towards perfection.
In addition, V3 uses a new technology called FastSat that accurately tracks very rapid changes in arterial oxygen saturation. FastSat is capable of tracking changes in saturations that went unnoticed before, and pointing to the troughs and peaks in arterial saturation that were not seen before. Clinicians who have seen V3 believe that FastSat will spur new research that may shed more light on patient oxygenation. For example, data collected with V3 in the NICU has shown brief desaturations unnoticed by other pulse oximeters that have lead to deep and dangerous desaturations. Researchers also believe that FastSat will aid clinicians beyond the acute and critical care environment. FastSat should become beneficial in sleep lab studies and the treatment of apnea.
“Pulse oximetry has long played an important role in diagnosis and treatment of patients with sleep disorders. After reviewing a series of recent publications and with my initial exposure to Masimo SET technology in the sleep disorders laboratory, it is clear that this technology offers improved signal quality relative to noise artifact and low perfusion states when compared to other pulse oximetry technologies currently available”, stated Robert A. Whitman, PhD, RRT, Diplomat, Board of Sleep Medicine, Director, Sleep Disorders Center, University of Kansas Medical Center. “We have recognized that the increased sensitivity allowed by the Masimo SET V3 technology with FastSat results in greater detailing of saturation changes associated with sleep-related respiratory events. This occurs without the false desaturations (false alarms) that occur with conventional pulse oximeters. This improved signal fidelity has the potential to allow pulse oximetry to play an even more important role in the screening and follow-up care of patients with sleep disordered breathing through greater reliability in arterial oxygen saturation monitoring.”
“With the introduction of Masimo SET, we proved that monitoring during motion and low perfusion was possible and not an inherent limitation of pulse oximetry. We reduced false alarms by over 90% and improved the detection of true alarms. Our goal is simple: make pulse oximeters perfect. Masimo SET V3 brings us closer to our goal”, stated Joe E. Kiani, President and CEO of Masimo Corporation.
Irvine, California, October 11, 2000 – Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, announced today the successful conversion of Huntington Memorial Hospital to its Masimo SET technology. Instrumental in this full-hospital wide conversion was Radical; Masimo’s recently released Signal Extraction Pulse Oximeter, which allows hospitals to use Masimo SET anywhere and everywhere. Radical can be used as a handheld pulse oximeter, a bedside standalone pulse oximeter or an upgrade device for validated multiparameter monitors. Huntington Memorial Hospital, located in Pasadena, California, is a 525-bed hospital offering a full complement of acute medical care and community services. Huntington Memorial Hospital is also a teaching facility affiliated with the University of Southern California School of Medicine and several nursing schools and colleges.
“Masimo has given our facility renewed confidence in pulse oximetry by providing us with accurate and reliable saturation values,” stated Gloria Sanchez-Rico, Department Manager Neonatal. “False alarms, due to motion and low perfusion, are a thing of the past, allowing our staff to focus their time and attention on their patient care rather than on alarm management. We evaluated many pulse oximeters, which we used to use before our conversion to Masimo SET. We realized that Masimo SET truly worked during motion, low perfusion and times when we needed pulse oximetry measurements the most. Once we decided that Masimo SET was the best product for our patients, we required all new products to include Masimo SET. But instead of waiting for new multiparameter monitors with Masimo SET, Radical provided us the opportunity to upgrade our current central monitors, giving us the opportunity to convert our complete hospital to Masimo SET. We are excited about our partnership - Masimo SET is truly remarkable technology.”
“As a healthcare provider, we are constantly looking for ways to reduce our costs while improving patient care,” stated Bonnie Ciribassi, Vice President, CNE. “We have done numerous studies on Masimo SET, and have found that this technology works when no other pulse oximeter worked, in places such as ECMO, Transport, OR, ICU, and NICU. We also have done studies to analyze the costs associated with other pulse oximeters and have seen noticeable improvements with Masimo SET, such as reduced sensor usage due to the quality and durability of Masimo’s single patient adhesive sensors. We proved to ourselves that Masimo SET could help us lower our costs while improving the care we give to our patients.”
“To see the adoption of our technology by a prominent teaching hospital such as Huntington Memorial is truly rewarding,” stated Joe E. Kiani, President and CEO of Masimo Corporation. “Going through such a process is not without its challenges, yet Huntington’s dedicated staff was determined to provide the best care possible and stayed with the process. We are grateful that we have been able to help Huntington Memorial continue its mission to provide the best care possible.”
Irvine, CA, October 10, 2000 – Masimo today announced that it has appealed the California District Court’s ruling refusing to preliminarily enjoin sales of Mallinckrodt’s N-395 Pulse Oximeter and MP404 Board for infringing a Masimo patent. Masimo strongly believes that in making this decision, the Court wrongly limited portions of Masimo’s patent. Further, contrary to Mallinckrodt’s public statements, the Court’s ruling only related to a portion of one of Masimo’s patents in the case and did not dismiss any patent from the lawsuit. While the appeal is pending, the case will proceed on additional claims in the patent that was the subject of the Courts ruling, as well as another patent that was the basis for Masimo’s initial filing of the lawsuit against Mallinckrodt a year ago.
“We are confident that the patent expertise of the Federal Circuit Court of Appeals court will lead to rectification of the erroneous patent interpretation," stated Joe E. Kiani, Chief Executive Officer of Masimo Corporation. “Our legal system, although slow and at times unpredictable, is still the best out there, and we continue to believe in it.”
Joe Kiani continued; “We have invested more than ten years developing and validating Signal Extraction Technology, which has now revolutionized pulse oximetry, to become a foul weather friend instead of the fair weather friend it had been. We were the first to prove that it is possible to monitor during motion, and we have openly shared our breakthrough technology with every company in the industry. Over 30 leading patient monitoring companies have embraced our technology and are providing Masimo SET to their customers, creating a win for everyone. However some companies have decided to use our technology without authorization. We will stand up to these actions.”
As for the countersuit brought against Masimo, Mr. Kiani stated: “Mallinckrodt’s countersuit remains a predictable response to divert attention from its unauthorized use of our technology. Having over 150 patents pending or issued to Masimo, we value the international patent law system and have been careful to design our products to respect the patents of other companies. Anyone looking at the Masimo SET products can see the level of innovation and the uniqueness of our designs. In fact, senior officials at Nellcor and Mallinckrodt have carefully reviewed our products for more than 7 years and never suggested our products might infringe their patents. However, in response to our patent infringement claims against them last October, they suddenly seemed to form a different opinion. In contrast, over a year before Mallinckrodt launched the N395 and MP404, we warned them that they would infringe our patents and tried earnestly to provide Nellcor with a win-win solution. Nellcor simply ignored us and launched the N395 and MP404 products anyway, giving us no choice but to file our lawsuit.”
GE Makes $5 Million Equity Investment in Masimo
MILWAUKEE and IRVINE, Calif., Oct. 5, 2000 -- Today, GE Medical Systems Information Technologies and Masimo Corporation announced that the companies have signed a technology licensing agreement that enables Information Technologies to offer Masimo Signal Extraction pulse oximetry as a platform choice for its line of patient monitoring systems. In addition, GE has made a $5 million equity investment in Masimo.
Masimo Signal Extraction pulse oximetry is a noninvasive technology used to obtain a patient's oxygenation levels and provide healthcare professionals with a reliable source of information for treatment. Recognized as the market innovator in motion and low perfusion pulse oximetry, Masimo SET has been clinically proven accurate in over 20 independent published studies.
"Masimo Signal Extraction Technology will be a powerful addition to our line of industry leading monitoring and clinical information systems," said Kevin King, vice president of Clinical Systems, GE Medical Systems Information Technologies. "Our expanded relationship with Masimo exemplifies our ongoing commitment to offer healthcare providers leading-edge technologies that can help improve clinical decisions and the quality of patient care."
Joe E. Kiani, president and chief executive officer, Masimo Corporation, stated, "This agreement is an important milestone for clinicians. Information Technologies' monitoring systems are well respected by healthcare professionals around the world, which will help accelerate the reach of Signal Extraction Technology to patients everywhere."
"We have invested more than ten years developing and validating Signal Extraction Technology and are pleased that GE has become a licensing partner and shareholder of Masimo," added Kiani.
An initial agreement between the two companies was signed in June 1999 for inclusion of Masimo SET into the Solar monitor. This new licensing and distribution agreement is an expansion that will allow the integration of Masimo SET into all of Information Technologies patient monitoring systems. Until Masimo SET is fully integrated into Information Technologies products, Radical with SatShare(TM) will be offered as an interim solution for customers wishing to upgrade their pulse oximetry technology immediately.
About GE Medical Systems Information Technologies
GE Medical Systems Information Technologies is a global leader in providing solutions for the reliable and efficient acquisition, analysis and management of patient data in healthcare facilities around the world. The company's offerings include cardiology, patient monitoring, image management, clinical information systems and performance management services. Information Technologies is a GE Medical Systems Company with global headquarters in Milwaukee, Wisconsin.
Additional information about Information Technologies and its products can be found on the company's web site at http://www.gemedicalsystems.com . GE Medical Systems is a $7 billion global leader in medical technology and services, employing nearly 20,000 people worldwide.
PORTLAND, Ore. & IRVINE, Calif.--Oct. 3, 2000--Welch Allyn Protocol, a leading supplier of patient monitoring technology, and Masimo Corp., the recognized market innovator in motion and low perfusion pulse oximetry, today announced continued progress towards the anticipated year-end launch of the Micropaq® wireless ambulatory monitor, the first Welch Allyn Protocol product to incorporate Masimo SET® technology.
Said Jim Welch, VP/General Manager of the Welch Allyn Protocol Flexible Monitoring® Business Unit, "The Micropaq has generated unprecedented clinician and market excitement. It creates an entirely new class of portable, wearable vital signs monitors that contribute to positive patient outcomes and caregiver productivity in lower cost settings in the hospital. The clinical effectiveness of the Micropaq depends upon pulse oximetry technology that offers both low power consumption and motion tolerance--features that only Masimo can offer us today."
"Clinicians associate high-performance, motion tolerant pulse oximetry with the Masimo brand name,'' said Robert F. Adrion, President & CEO of Welch Allyn Protocol. "We will continue to work closely with Masimo to offer Masimo SET oximetry solutions in other monitors as they become available."
"We are pleased with our continuing relationship with Welch Allyn Protocol," stated Joe E. Kiani, President and CEO of Masimo Corp. "The need for a low power OEM board and clinically proven technology in motion and low perfusion environments made Masimo's MS-3L board a perfect fit for Micropaq."
The Micropaq monitor, including ECG, heart rate and pulse oximetry, is currently pending FDA 510(k) market clearance.
About Welch Allyn Protocol
Welch Allyn Protocol, Inc. designs, manufactures and markets mission-critical flexible monitoring solutions that improve patient care and lower healthcare operating costs. Welch Allyn Protocol uses innovative computer and software technologies to provide vital patient data and connect clinicians with mobile patients via workstations, wireless devices and the Internet. Welch Allyn Protocol is a wholly owned subsidiary of Welch Allyn, Inc. and is based in Beaverton, Oregon. Its products are available in more than 90 countries around the world.
Welch Allyn, Inc. was founded in 1915 and is today a leading manufacturer of innovative medical and dental diagnostic equipment and miniature precision lamps. Headquartered in Skaneateles Falls, New York, U.S.A., Welch Allyn, Inc. has more than 2,000 employees and numerous manufacturing, sales, and distribution facilities located throughout the world.
Researchers conclude that Masimo SET outperforms Nellcor N395 in terms of sensitivity and specificity and is more accurate and reliable under conditions of patient motion
Irvine, Calif, September 25, 2000 - Masimo Corporation today announced that Masimo SET® technology performed better than the Mallinckrodt-Nellcor N395 monitor during motion and low perfusion, according to the results of a new independent study performed by Steven J. Barker, PhD, MD, Professor and Head of the Department of Anesthesiology at University of Arizona. The study appears in Anesthesiology 2000*. Dr. Barker has published more than 25 studies related to oxygen monitoring.
Dr. Barker’s study compares the Mallinckrodt Nellcor N395 (Oxismart XL) with Masimo SET technology during hypoxemia and motion. The results of the study show that Masimo SET detected true hypoxemias and rejected false alarms significantly better than the N395 pulse oximeter.
Steven Barker, M.D., Ph.D., Professor and Head of the Department of Anesthesia of University of Arizona, stated: “During mechanically controlled and reproducible motion, both periodic and random (erratic and chaotic) of adult subjects’ hands, Masimo SET detected true hypoxemias significantly better than the N395 pulse oximeter. Masimo SET correctly detected 95% of all true hypoxemic events, compared with 63% for the Nellcor N395. Masimo SET’s ability to detect true hypoxemic events was achieved without sacrificing specificity. In fact, Masimo SET had the lowest false alarm rate; it rejected 97% of the false alarms. The Nellcor N395 not only missed 37% of the true alarms, but it also alarmed falsely 5 times more than the Masimo SET pulse oximeter.”
Certain statements contained in this press release, including statements regarding Masimo’s expectations, beliefs, plans, intentions, market position, relationship with customers or strategies regarding the future are forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). All forward-looking statements included in this release are based upon information available to Masimo as of the date of the release, and we assume no obligation to update any such forward-looking statement. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, market acceptance and profitability of Masimo’s products and litigation over property rights. These and other factors are risks associated with our business that may affect our operating results and are discussed in Masimo’s filings with the Securities and Exchange Commission, including our registration statement on Form S-1.
*The study is titled, A Comparison of the Nellcor N-395 and Masimo SET Pulse Oximeters during Hypoxemia and Motion in Human Volunteers. The authors are Steven J. Barker, Ph.D., M.D., and Scott E. Morgan, B.S. Anesthesiology 2000;93:3A,A549.
Former GE Medical Systems Executive Joins Board
Irvine, California, September. 21, 2000 -- Masimo Corporation, the developer of Signal Extraction pulse oximetry, announced today that it has appointed Fred Robertson, M.D. to its Board of Directors.
Dr. Robertson brings with him a wealth of experience and knowledge as well as a strong track record of managing companies in the medical technology arena. Most recently, Dr. Robertson held the position of Chief Clinical Officer of GE Medical Systems. Since 1993 he held various management positions with GE Marquette Medical Systems and the former Marquette Medical Systems including President and CEO. Dr. Robertson is certified by the American Board of Anesthesiology and serves as a director of the Anesthesia Patient Safety Foundation. He is currently an Associate Clinical Professor of Anesthesiology at the Medical College of Wisconsin. Dr. Robertson holds an M.D. degree from the University of Wisconsin Medical School and an M.B.A. from San Diego State University.
"I first became aware of the Masimo technology five years ago at the Society for Technology in Anesthesia Meeting," Dr. Fred Robertson stated. "At the time I was President of the Patient Monitoring Division of Marquette. As an anesthesiologist and a responsible member of our industry, I appreciate the impact that Masimo SET technology has made clinically and believe in Masimo's mission to deliver this technology to clinicians around the world."
"Fred is a valuable addition to our Board of Directors," stated Joe E. Kiani, Chief Executive Officer and Chairman of the Board of Masimo Corporation. "Fred's experience as both an anesthesiologist and an industry leader will be invaluable as we continue to grow. We welcome Fred to our Team."
Irvine, California, July 31, 2000 - Masimo Corporation today announced the appointment of George Ryan as Vice President of Business Development.
Mr. Ryan has over 20 years experience in the Medical Device Industry, most recently as Director of New Business Development for Hill-Rom, a leader in maternal infant care, patient transport and support systems, where Mr. Ryan focused his efforts on business expansion through acquisitions, mergers and licensing innovative technology solutions. Prior to joining Hill-Rom, he held positions with Spacelabs Medical, a leader in critical care patient monitoring, as a Senior Staff Member, Director of World Wide Marketing and Business Development for Respironics and Director of R&D for Baxter. Mr. Ryan has also been involved with various domestic and international ventures and start up activities during his career.
“I came to Masimo because I believe that Masimo has a technology that will have far reaching impacts on patient care,” stated George Ryan. “It is rare for a product or technology to be able to improve care while reducing the cost of care, but revolutionary products always do both. I believe that Masimo Signal Extraction pulse oximetry will effectively change the way patients are monitored, allowing them to be safely monitored, transferred to lower cost settings and even to be discharged sooner. It will also increase the number of settings where pulse oximetry is effectively used while decreasing the need for more expensive and invasive procedures. The most important benefit will be increased vigilance by clinicians because they will finally have a pulse oximeter that they can rely upon. I like to think of Masimo SET as a disruptive technology. If you wonder what I mean, just ask Nellcor.”
“George is a key addition to our management team,” stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “George will focus on expanding our base of licensing agreements with the world’s patient monitoring companies as well as expanding the scope of each of these partnerships to create the next generation of monitors with Masimo SET pulse oximetry. We believe that George’s extensive experience in our industry and solid track record, makes him uniquely qualified for this role.”
Montreal, Canada, June 27, 2000 - The clinical benefits of Masimo SET pulse oximetry was the topic of three presentations on Monday at the third World Congress of Pediatric Intensive Care, held in Montreal, Canada. The panel, which consisted of members from Canada, Japan and the US, presented Masimo SET Pulse Oximetry as a significant improvement in pulse oximetry and that its use worldwide would improve patient care and safety.
Geoffrey A. Barker, MD, Congress Chairman and Professor and Chief, Department of Critical Care Medicine, Hospital for Sick Children in Toronto, was the moderator of a satellite session entitled “Clinical Implications of Masimo SET Pulse Oximetry.” In his opening remarks, Dr. Barker discussed the importance of the information provided by patient monitors and how there are significant problems with monitors, which causes the information to be inaccurate at times. With specific reference to pulse oximetry, he told the audience, “There has been significant improvement in this technology and we are delighted to be able to share with you this new pulse oximetry technology (Masimo SET).”
The session included lectures from three world-renowned clinicians. Katsuyuki Miyasaka, MD, FAAP, Anesthetist-in-Chief and Director Department of Anesthesiology and ICU at the National Children’s Hospital in Tokyo, Japan, spoke to the audience about his efforts to improve pulse oximetry monitoring in his hospital. According to Dr. Miyasaka, “Pulse oximetry is by far the most frequently used monitor, but its readings can not be trusted entirely and its alarms are frequently ignored. We have become used to it and have been a slave to it for the past 20 years. Now it is time to wake up.” He discussed a study that he completed on 50 infants in the operating room and stated; “There was a ten-fold decrease in false alarm duration with Masimo SET as compared to the conventional pulse oximeter.” He told the audience about a campaign started in his hospital in 1979 called “Sound of Silence” with the aim to decrease distractions such as false alarms with the goal of improving vigilance for the sake of patient safety. Dr. Miyasaka commented, “The pulse oximeter has been the major obstacle for this campaign, but not any more with Masimo SET.”
Dr. Steven J. Barker, PhD, MD, Professor and Head of Anesthesiology at the University of Arizona School of Medicine, discussed his extensive research in the area of pulse oximetry over the past several years. He discussed in detail his recent study, which included 17 of the most widely used pulse oximeters and their performance during motion artifact. The study was of particular interest because it included the most recent and talked about products which claim superior performance during motion artifact, Masimo SET and Mallinckrodt Nellcor N395/Oxismart XL. He discussed the results, which clearly showed Masimo SET to be by far the most reliable in catching true hypoxemic events while decreasing false alarms. In summary he stated, “The Masimo SET pulse oximeter demonstrates better accuracy and reliability… preliminary studies of low perfusion combined with hypoxemia suggest a similar benefit. Masimo SET pulse oximetry should have a significant impact on critical care in all settings.”
Mitchell R. Goldstein, MD, FAAP, Associate Neonatologist, Citrus Valley Medical Center in West Covina, California, discussed his clinical studies and clinical experiences using Masimo SET, in particular, his involvement with a baby with a serious heart ailment. Various monitors, including the conventional pulse oximeter, were unable to attain readings due to the baby’s desperate condition. He attached a Masimo SET pulse oximeter to the baby and attained a reading immediately. According to Dr. Goldstein, “If it were not for the pulse oximetry readings from the Masimo SET device, we would have discontinued the resuscitation on this baby. It is likely that this baby’s life was saved because of Masimo SET technology.”
Dr. Goldstein commented, “There is a clear difference between the new pulse oximetry technologies now available for clinical use. Some other manufacturers have chosen to use alarm management to deal with false alarms. In effect, these systems hold alarms based on prescribed parameters so that clinicians are not disturbed. This defeats the purpose of the monitor and nullifies its usefulness. Studies have shown that alarm management actually increases the incidence of missing true alarms, which is a significant safety issue. Fortunately, we now have a real solution with Masimo SET, so there is no reason to debate the issue any longer…For pulse oximetry to achieve its potential in the 21st century as the fifth vital sign, it must be dependable and able to provide meaningful, life-critical information. Masimo SET is that technology; it works when we need it most.”
IRVINE, Calif., June 21, 2000 - A pulse oximetry reliability study on children in the postanesthesia care unit (PACU) was published in this month’s edition of Anesthesia and Analgesia (Anesth Analg 2000;90:1336-40). The study showed that Masimo SET significantly improves detection of true hypoxemic events while dramatically reducing false alarms. The study was conducted by Shobha Malviya, MD, Paul Reynolds, MD, Terri Voepel-Lewis, BSN, MS, Monica Siewert, BA, David Watson, MD, Alan Tait, PhD, and Kevin Tremper, PhD, MD at the University of Michigan Health System, Ann Arbor Michigan. The University of Michigan researchers compared Masimo SET to conventional pulse oximetry from Nellcor, the N200, which has been the most commonly used pulse oximeter.
Seventy-five children were monitored for a total of 42 hours and the results showed that Masimo SET pulse oximeters reduced false alarms by 60%, yet caught 100% of the hypoxemic events (true alarms). The Nellcor pulse oximeter missed 41% of the hypoxemic events. Some of the hypoxemic events missed by the Nellcor pulse oximeter lasted up to four minutes, which is long enough to cause death or brain damage. In discussing these results, the researchers wrote, “The single most important characteristic of a pulse oximeter is to identify all episodes of hypoxemia (i.e., high sensitivity) to permit intervention before the development of clinically significant hypoxemia. Failure to capture these episodes may result in fewer alarms, but may also lead to a false sense of security, and thereby delay appropriate intervention … In our study, each episode of [Masimo SET] device-detected hypoxemia responded appropriately to treatment (e.g., administration of oxygen or patient stimulation).”
In addition to the importance of sensitivity in detecting true alarms, the researchers discussed the impact of a high rate of false alarms. “A high incidence of FAs (false alarms) in pulse oximetry may lead to complacency of care by providers who have become desensitized to alarms. This may result in delays in response to clinical events.”
“It is great to see this excellent research published in Anesthesia and Analgesia,” stated Joe E. Kiani, President and CEO of Masimo Corporation. “This is an important study not just for Masimo, but for all patients. There has been a recent mandate in the U.S. to reduce mortality and morbidity due to human errors. It’s evident from the large body of clinical studies on Masimo SET that some of the errors can be simply reduced by upgrading from conventional pulse oximetry to Masimo SET. Conventional pulse oximeters fail to work when they are needed; this can lead to morbidity and death. If Masimo SET was used on all patients in every hospital, I am convinced that lives could be saved and/or improved. Masimo SET has been clinically proven over the last five years to work when it’s needed most. This study, along with the neonatal study published in the May edition of the Journal of Critical Care Medicine and Dr. Barker’s latest study on 17 pulse oximeters presented at the World Congress of Anesthesia two weeks ago, all offer compelling proof that Masimo SET pulse oximetry dramatically reduces false alarms. More importantly, it does so while identifying the true alarms that conventional pulse oximeters miss.”
Dr. Kevin K. Tremper, Chief of Anesthesiology at the University of Michigan, commented, “Masimo has truly made a contribution with its Signal Extraction Technology. Now it’s up to my peers in the clinical community to use this breakthrough technology throughout the continuum of care for the betterment of patients.”
IRVINE, Calif., June 15 -- Masimo Corporation today announced that Franklin Templeton Investments has invested $10 million in Masimo.
"It is with pleasure that we welcome this blue-chip investor to our esteemed group of investors,'' stated Joe E. Kiani, Chief Executive Officer and Chairman of the Board of Masimo Corporation. "We raised $10 million primarily to finance increased production demand of our new Radical(TM) Signal Extraction(TM) pulse oximeter. Less than a year ago, we had forecasted to build a few thousand Radical units for our first year of shipment in 2000, but within only the first months of presales, we have booked orders that exceeded our forecast for the year. We are doing our best to meet the demands of our customers and soon hope to have Radicals off of allocation. We are now building up capacity for significantly higher production of Radical and should catch up with demand by October.''
Mr. Kiani continued, "It seems that now that clinicians have seen for themselves the accuracy and reliability that's possible with Masimo SET, many wish to have their entire hospital standardized on Masimo SET. Radical, along with our partners' products that range from multiparameter patient monitors with Masimo SET to defibrillators with Masimo SET, allows hospitals to give the best and safest care possible with Masimo SET pulse oximetry. Our distribution partners in North America for Radical are Allegiance, Datex-Ohmeda and Ohmeda Medical and we expect to announce our international distribution partners soon.''
Radical Signal Extraction Pulse Oximeter is three pulse oximeters in one: a standalone pulse oximeter for bedside monitoring; a detachable handheld pulse oximeter for reliable and accurate monitoring during transport and spot check; and a monitor interface, called SatShare(TM), for upgrading existing multi-parameter patient monitors to Masimo SET technology. Radical can provide continuous and reliable arterial oxygen saturation monitoring anywhere throughout the continuum of care: EMS, ER, OR, ICU, recovery room, home, in any specialty clinic and the general floor. Radical delivers the unsurpassed accuracy and reliability of Masimo SET technology with multi-functionality, ease of use, and a convenient upgrade path for existing monitors.
Franklin Advisers, Inc. is a wholly owned subsidiary of Franklin Resources, Inc. (NYSE: BEN), a global investment organization operating as Franklin Templeton Investments. Through its subsidiaries, Franklin Templeton Investments provides global and domestic investment, shareholder and distribution services to the Franklin, Templeton and Mutual Series funds and institutional accounts, as well as separate account management services. The San Mateo, CA-based company has over 50 years of investment experience and more than $222 billion in assets under management as of May 31, 2000.
Study Concludes that Masimo SET Pulse Oximetry Should Have a Significant Impact on Critical Care in All Settings
Montreal, Canada, June 7, 2000 - Steven J. Barker, PhD, MD, Professor and Head of Anesthesiology at the University of Arizona College of Medicine, presented a comprehensive study comparing the performance of the newest pulse oximetry technologies during motion at the 2000 World Congress of Anesthesiologists meeting, held in Montreal this week. The study showed that Masimo SET significantly outperformed all of the other pulse oximeters tested, in terms of accuracy, reliable detection of hypoxemia and reduction of false alarm rate. The World Congress of Anesthesiologists nominated Dr. Barker’s study for the scientific study poster award.
Dr. Barker’s study is the first and only independent study comparing the Mallinckrodt Nellcor N395 (Oxismart XL) with Masimo SET. Dr. Barker stated: “Our results clearly show that the Masimo SET oximeter performs better during motion than the other units tested.”
During mechanically controlled and reproducible motions of adult subjects’ hands, Masimo SET detected true hypoxemias significantly better than all the pulse oximeters tested. Masimo SET correctly detected 98% of all true hypoxemic events, compared with 63% for the Nellcor N395. Masimo SET’s dramatic improvement in detecting true hypoxemic events was achieved without sacrificing specificity. In fact, Masimo SET had the lowest false alarm rate of the 17 pulse oximeters tested: Masimo SET rejected 92% of the false alarms. The Nellcor N395 not only missed 37% of the true alarms, but it also alarmed falsely nearly 5 times more than the Masimo SET pulse oximeter. The other instruments tested had highly variable detection of true alarms and rejection of false alarms, but all significantly under performed compared to Masimo SET.
Dr. Barker continued, “The Masimo SET pulse oximeter had the highest sensitivity (probability of hypoxemia detection or true alarm rate) and the highest specificity (lowest probability of false alarms). This new technology should have a significant impact on critical care in all settings, particularly those in which patient motion is likely.”
Masimo Initiates Procedures to Seek Preliminary Injunction Against Mallinckrodt’s Nellcor N395 and MP404 OEM Board
Irvine, California, June 4, 2000 - Masimo Corporation today announced several recent advances in its patent infringement lawsuit against Mallinckrodt and Nellcor. Last week, the Federal District Court in Delaware granted Masimo’s motion to transfer Mallinckrodt’s countersuit from Delaware to California, where Masimo originally filed suit against Mallinckrodt for patent infringement in October 1999. Masimo also recently initiated procedures to seek a preliminary injunction to prevent Mallinckrodt’s further distribution of its infringing N395 pulse oximeter and MP404 OEM printed circuit board and added a recently issued patent relating to the use of adaptive filters in pulse oximetry to its lawsuit. This patent is significant because Nellcor has publicly admitted that it is using adaptive filters.
“We are very pleased with the progress in our case against Mallinckrodt and Nellcor,” stated Joe Kiani, President and Chief Executive Officer of Masimo Corporation. “We filed our lawsuit in California because both Masimo and Nellcor are located in California. I believe Mallinckrodt’s countersuit in Delaware illustrates its attempt to turn the suit into a check-writing campaign. I am pleased that the Delaware Court transferred Mallinckrodt’s case to California.” Mr. Kiani continued, “As to our decision to seek a preliminary injunction, with so much invested in our technology, to allow Mallinckrodt to use our technology throughout the lawsuit would be an injustice.”
IRVINE, Calif., May 31, 2000 - A milestone clinical study was published in this month’s Journal of Critical Care Medicine which concluded that Masimo SET pulse oximetry was the most reliable pulse oximeter tested in terms of true alarm detection despite a 93% reduction in alarms. The study entitled “Pulse oximeters’ reliability in detecting hypoxemia and bradycardia: Comparison between a conventional and two new generation monitors” compared Masimo SET to Mallinckrodt/Nellcor’s N200 and Oxismart monitors. The study was conducted by Bettina Bohnhorst, MD, Corina Peter, MD and Christian Poets, MD at the Department of Neonatology and Pediatric Pulmonology, Medical School, Hannover, Germany.
The researchers had previously published a study where they had concluded that Masimo SET pulse oximetry generated 93% fewer alarms than pulse oximeters with conventional technology (“Major Reduction in Alarm Frequency with a New Pulse Oximeter” Intensive Care Medicine 1998;24(3):277-278). This current study was conducted to evaluate whether new low false alarm pulse oximetry technology from Masimo and Nellcor Puritan Bennett achieved their results at the cost of missing true hypoxemia and bradycardia events.
The study showed that the N-3000 (Nellcor Oxismart) failed to detect 10 (5.4%) of true hypoxemic events, while the Masimo SET instrument missed only 1 (0.5%). The results in detecting bradycardic events were even more dramatic with the Oxismart missing 37 (69%), and Masimo SET missing only 4 (7%). The researchers concluded; “It thus appears that this instrument’s (Oxismart N-3000) reduced false alarm rate is achieved at the expense of an unreliable and/or delayed identification of hypoxemia and bradycardia. The other low-alarm-rate instrument (Masimo SET) identified both conditions equally or even more reliably than a conventional pulse oximeter (N-200)”.
In an editorial written for the same journal discussing this landmark study, Dr. Kevin Tremper, MD, PhD, FCCM of the University of Michigan stated, “The authors are appropriately concerned that any device that claims to reduce motion artifact may also reduce the detection of true positive events. Clearly a monitoring device is of little value and is potentially dangerous if it has a significant false negative rate. The authors concluded that … the Nellcor OXISMART (Nellcor Puritan Bennett, Pleasanton, CA), improved its function at the expense of an increased number of false negative values.”
“Masimo SET’s ability to substantially eliminate false alarms is critical to making pulse oximeters useful safety monitors,” stated Joe E. Kiani, President and CEO of Masimo Corporation. “In 1989, when we set out to eliminate false alarms, we knew that it would be unacceptable if we reduced the false alarms at the expense of missing true alarms. Dr. Poets’ studies have shown that Masimo accomplished its mission by not only dramatically reducing false alarms, but by also detecting true alarms more accurately than the N200 pulse oximeter, which has been used by hospitals for more 10 years.”
Mr. Kiani continued, “The clinical community has been subjected to a barrage of misinformation lately regarding advancements in pulse oximetry. When we created Signal Extraction pulse oximetry, we chose to let independent clinical research deliver the message about improved performance to the clinical community. Unfortunately Mallinckrodt chose a different path. They chose to publish internal studies, call their alarm management breakthrough technology and to use their vast resources to misinform clinicians and discredit Masimo SET. Fortunately the clinical community seems to be more interested in science than fiction as the superior performance of Masimo SET has now been confirmed in 26 independent published studies. So far, more than half of the world’s pulse oximetry suppliers have adopted Masimo SET as their standard platform and approximately 25,000 Masimo equipped pulse oximeters are currently in use. We hope that mass adoption of Masimo SET pulse oximetry will result in better patient care.”
IRVINE, Calif., May 22 -- Today, Masimo Corporation announced that it is the recipient of the 2000 American Electronics Association (AEA) award for Outstanding Medical Device Company. This award, presented as part of the Seventh Annual High-Tech Awards event of the Orange County Council, is presented to the company demonstrating excellence in technological innovation and leadership in the medical device industry.
The High-Tech Awards honor a wide range of high-technology categories including Outstanding Medical Device Company, Outstanding Public Company, Outstanding Software Company, Outstanding Internet Company, Outstanding Executive (public and private company), Mentor/Angel, and Innovative Product/Technology.
According to Phil Beaudoin, executive director, Orange County Council, AEA, “These companies and executives serve as outstanding examples of the innovative technology that continues to be developed and enhanced at the local level. They have set the precedent for technology growth in Orange County for the new century.”
“Masimo is honored to be recognized by the American Electronics Association,” said Joe E. Kiani, President and CEO of Masimo Corporation. “Masimo is a classic Orange County start-up. Eleven years ago, we started in a garage and our goal was, and still is, to make a contribution by developing better technology for patient care. In our pursuit of this goal, we have been fortunate to develop a technology that today, is not only saving lives and improving patient care, but is also reducing the cost of care. Over 25 clinical studies by independent researchers have proven Masimo Signal Extraction Technology to be the only pulse oximetry technology accurate under the most challenging conditions of motion and low perfusion and when it’s needed most.”
Mr. Kiani continued, “This award belongs to everyone on the Masimo Team, our employees, advisors, investors, clinical researchers, and the business community in Orange County, who believed in us, encouraged and supported us.”
About AEA
The American Electronics Association is the nation's largest high-tech trade group, representing more than 3,000 U.S.-based technology companies. Membership spans the industry product and service spectrum, from semiconductors and software to computers, Internet and telecommunications systems and services. With 18 regional U.S. councils and offices in Brussels, Tokyo and Beijing, AEA offers a unique global policy grassroots capability and a wide portfolio of valuable business services and products for the high-tech industry. For 56 years, AEA has been the accepted voice of the U.S. technology community.
IRVINE, Calif., May 12, 2000 -- Today, Masimo Corporation announced that it is the recipient of one of Frost & Sullivan’s highest honors for Market Engineering: the 2000 Competitive Strategy Award
This award, based on independent research and analysis of companies in the health care industry, recognizes Masimo for its positive contribution to the blood gas monitoring equipment market.
According to Frost & Sullivan analyst, Minal Vasanawada, “Masimo has made a significant impact on the industry with its successful marketing of its proprietary Signal Extraction pulse oximetry technology, Masimo SET®. False alarms and erroneous readings due to patient and environmental factors have for long plagued pulse oximetry technology. By addressing this pressing need to have more accurate data from pulse oximeters in varied clinical settings including motion and low perfusion, Masimo has displayed a clear understanding of the primary competitive factors in this industry. Frost & Sullivan recognizes this outstanding achievement and awards Masimo with its Competitive Strategy Award.”
“Masimo is honored to be recognized by Frost & Sullivan for the advancement and contribution Masimo has made in the field of pulse oximetry,” said Joe E. Kiani, President and CEO of Masimo Corporation. “Our goal was to solve what other companies thought was unsolvable - to make pulse oximetry accurate during motion and low perfusion. We then set out to educate the industry and health care professionals with independent clinical studies by leading clinicians around the world and true side-by-side demonstrations. Today, over 25 clinical studies by independent researchers have proven Masimo Signal Extraction Technology to be the only pulse oximetry technology accurate under the most challenging conditions of motion and low perfusion and when it’s needed the most. We wish to thank the dedicated clinicians who, without any personal monetary reward, have spent their valuable time and resources to study Masimo SET’s performance compared to conventional pulse oximetry and Masimo SET’s effect on improving patient care as well as reducing cost of care.”
Mr. Kiani continued, “By proving the breakthrough accuracy and reliability of Masimo SET technology clearly and honestly, we have been able to attract over 30 leading patient monitoring companies, who make up over 50% of the world’s pulse oximeter suppliers - to adopt Masimo SET as their standard pulse oximetry technology. These companies have spent significant resources to upgrade their products to Masimo SET for the benefit of their customers; they should also be honored. Receiving honors such as this Frost & Sullivan Award and the appreciation from clinicians and patients who have been helped by our technology, renews our commitment to continue to advance signal processing and sensor technology for the benefit of patients and to be driven by a sense of fascination and accomplishment.”
Recently Masimo announced Radical, a product that is accelerating the standardization of Masimo SET pulse oximetry throughout hospitals. The Radical Signal Extraction pulse oximeter allows clinicians to get access to Masimo SET. It is three pulse oximeters in one: a standalone device for bedside monitoring, a detachable handheld pulse oximeter for ultra-portable monitoring and a monitor interface, called SatShare, which allows Radical to upgrade multi-parameter patient monitors to Masimo SET technology. Radical can provide continuous and reliable arterial oxygen saturation monitoring anywhere throughout the continuum of care. With help from some of our partners, particularly Allegiance and Datex-Ohmeda, who have vast distribution resources and flexible acquisition programs, Masimo is making it easy for clinicians to get access to Radical to standardize their hospitals to Masimo SET pulse oximetry.
About Frost & Sullivan
Frost & Sullivan, an international market consulting and training firm, presents Market Engineering awards to companies that demonstrate the diligence, perseverance, and dedication required to develop a successful business plan and excel in the increasingly competitive global marketplace. Frost & Sullivan rigorously analyzes specific criteria to determine Market Engineering Award recipients in a variety of regional and global market landscapes. Founded in 1961, Frost & Sullivan is recognized as a global marketing research and solution leader, with offices located worldwide: Silicon Valley, New York, San Antonio, London, Paris, Frankfurt, Beijing, Tokyo, Singapore, and Bumbai. For further information contact www.frost.com.
Masimo Corporation Announces New Pulse Oximetry Noise Reduction NR7™ Adult Disposable and NR125™ Adult Reusable Sensors
New NR Sensors Offer Performance Improvement Over Conventional Pulse Oximeter Sensors, but at over 30% Discount in Price
Irvine, California, April 24, 2000 - Masimo Corporation today announced its new “NR” line of pulse oximetry sensors that will offer performance improvement over conventional disposable and reusable pulse oximetry sensors. With the addition of the NR sensors to Masimo’s current family of Masimo SET® LNOP® sensors, clinicians can get the best value at the performance level they need.
Masimo SET LNOP sensors were designed for neonates and the sickest patients in mind; for patients with low perfusion and the most challenging motion environments. NR sensors offer an improvement in performance over conventional pulse oximetry sensors, but are designed for the lower acuity patients.
Masimo has historically only offered its Signal Extraction Technology LNOP line of single patient adhesive and reusable sensors. These Masimo SET LNOP sensors have been designed to maximize the performance of Masimo SET signal processing software and hardware by providing maximum noise interference rejection. The Masimo SET LNOP single patient adhesive sensors also decrease costs due to their performance, and durability. The Masimo SET single patient adhesive sensors are constructed of durable and rejuvenatable materials, that studies have shown to last nearly twice as long as conventional disposable sensors. This durability allows the sensors to last the entire length of the patient’s stay in most cases. Because of their breakthrough performance, reliability and durability, the Masimo SET sensors have been and will continue to be the best choice sensor for users who need the superior performance and want more for their money, and not simply the lowest price at time of purchase.
NR sensors offer immediate value and improved performance over conventional pulse oximetry sensors, complimenting the Gold Standard Masimo SET LNOP sensors. Hospital administrators are pressured to reduce cost; Masimo SET LNOP sensors and NR sensors will help them do just that. But, NR sensors will only be made available to hospitals and group purchasing organizations, which stock both types of sensors, allowing their clinicians to make the final choice of the type of sensor they wish to use on their patients. Although, the new NR sensors will function better than conventional pulse oximeter sensors, they will not perform as well as Masimo SET LNOP sensors under motion and low perfusion conditions. Masimo believes only clinicians have the training and experience necessary to decide if their patients are at risk and require the Masimo SET LNOP sensors or are not in a critical and challenging condition where NR sensors may be used instead.
“NR sensors represent another step in freeing the pulse oximetry users,” stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “For years, clinicians were taught that they had to accept pulse oximetry failures during motion and low perfusion and had to purchase their sensors only from one source; not any more.”
Mr. Kiani continued, “When our partners, such as Atom, Datascope, Ohmeda Medical, and Zoll introduced Masimo SET pulse oximetry with the Masimo SET sensors, clinicians realized that pulse oximetry could be a “foul weather friend,” and could be relied upon even for their most difficult patients who had low perfusion or were moving. Last week we announced the FDA clearance with expanded claims for the Radical Signal Extraction pulse oximeter. With Radical, we have delivered a pulse oximeter monitor that will not only function in virtually any situation, but will also upgrade existing conventional monitors to the new Masimo SET performance standard. Now that our 30-plus partners can offer hospitals true pulse oximetry standardization, hospital administrators and clinicians may want a choice of performance and price for varying degrees of patient acuity. The addition of NR sensors to our line of Masimo SET sensors gives hospital administrators and clinicians that choice, simply by selecting sensors, not equipment. Clinicians and hospital administrators now have a choice in performance, in price and in whom they buy their sensors from.”
Irvine, CA, April 20, 2000 - Masimo Corporation announced that it has received clearance from the FDA to expand the indications for use for its Radical Signal Extraction pulse oximeter to include mobile environments. The Masimo SET® technology’s ability to work under motion and other challenging conditions makes it the ideal technology for mobile environments. Masimo SET is the first technology ever to receive FDA clearance for accurate monitoring under conditions of patient motion and low perfusion, on all patient populations, including adults, pediatrics and neonates.
Pulse oximetry is the noninvasive measurement of arterial oxygen saturation and pulse rate. It is widely used and is considered a standard of care to monitor critically ill patients at risk of respiratory distress. Despite its promise, pulse oximetry has been plagued by its inability to remain accurate and reliable primarily due to patient motion, low peripheral perfusion, intense ambient light and electro-surgical (ESU) interference. The result has been a high rate of false alarms and missed true alarms, which reduces the usefulness of pulse oximetry when monitoring critically ill patients.
Masimo Corporation has created Signal Extraction pulse oximetry for the express purpose of solving these problems. Masimo's proprietary signal processing and sensor technology, Masimo SET, is the only pulse oximetry technology which has been clinically proven accurate in more than 20 independent, peer reviewed clinical studies to work under motion artifact, low perfusion and when it’s needed the most. These studies have been published in prestigious journals and all concluded that Masimo SET pulse oximetry exhibits far fewer false alarms and failures, while being more reliable in detecting true alarms.
The Radical Signal Extraction pulse oximeter is three pulse oximeters in one: a standalone device for bedside monitoring, a detachable handheld unit for easy portable monitoring and a monitor interface to upgrade existing multi-parameter patient monitors to Masimo SET technology. Radical can provide continuous and reliable arterial oxygen saturation monitoring anywhere throughout the continuum of care: EMS, during transport, in the ER, OR, ICU, recovery room, home, in any specialty clinic, the general floor and mobile environments.
Radical's unique upgrade capability gives clinicians a quick, easy and affordable way to upgrade their existing conventional pulse oximeters to Masimo SET performance. The existing upgrade option for most multi-parameter monitors is to purchase an additional upgrade module. Radical’s Satshare® feature allows the upgrade to be done through the standard patient cable input without the additional module. This plug and play method will save the hospital time and as much as two thousand dollars for each unit.
"These expanded claims further enforce that Masimo SET is the one pulse oximetry technology that can be relied upon under the most difficult conditions, when it is needed most," stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “Pulse oximetry has been unreliable during motion artifact and low perfusion and especially in mobile environments due to the high levels of patient motion, electrical and ambient light interference. With Masimo SET, critically ill patients can be transported with continuous and reliable Signal Extraction pulse oximetry monitoring. We are delighted by the market acceptance of Radical and expect that this new clearance will pave the way for Radical to help improve patient outcome and reduce cost of care by making the Gold Standard Masimo SET pulse oximetry technology available throughout the continuum of care."
Irvine, CA, March 9, 2000 - Protocol Systems (Beaverton, Ore.) and Masimo Corporation (Irvine, Calif.) today announced a purchasing and licensing agreement under which Protocol will integrate Masimo Signal Extraction pulse oximetry technology into its future patient monitor platforms, which incorporate pulse oximetry. Protocol is a leading manufacturer of flexible and portable patient monitoring equipment and Masimo is the recognized technology leader in pulse oximetry.
Protocol today announced its plans to include Masimo SET technology in their wireless Micropaq ambulatory patient monitor. Micropaq combines the function and form of a patient-worn telemetry monitor with the display, alarms and parameters of a portable standalone vital signs monitor.
“Micropaq is a product designed to meet the increasing demands for ambulatory patient monitoring of cardiac patients,” stated Robert F. Adrion, President and CEO of Protocol Systems. “As such, it requires the most reliable monitoring available in small, low power modules. And, in ambulatory monitoring, reliability during patient motion is a must. We are proud to have Masimo SET in Micropaq and feel that it is one of the key features that will make Micropaq a valuable patient monitor to clinicians.”
Joe E. Kiani, President and CEO of Masimo Corporation, stated, “Micropaq is a continuation of Protocol’s tradition of breaking size and flexibility barriers. We are proud that Protocol has chosen Masimo SET as their pulse oximetry platform for this amazing product and are delighted to add Protocol to our list of partners.”
Protocol Systems Inc. designs, manufactures and markets patient monitoring instruments, systems and technologies utilizing innovative design, advanced software concepts and leading electronic technology. Protocol is based in Beaverton, Oregon and its products are available in more than 90 countries around the world.
ST. LOUIS, February 25, 2000 - AmeriNet, the largest membership-based health care group purchasing organization (GPO) in the United States, has signed an agreement with Masimo Corporation to provide Masimo Signal Extraction Technology (SET) pulse-oximetry in a variety of configurations to AmeriNet member hospitals. AmeriNet has agreed to endorse and promote Masimo SET exclusively as the solution for motion and low perfusion. Masimo has agreed to provide preferred pricing plans to AmeriNet members including capitation, rebates and tradeouts. The agreement became effective January 24, 2000.
Conventional pulse oximetry can be subject to inaccurate readings and false alarms primarily caused by patient movement and low blood flow to the sensor site on the patient’s finger or toe. Masimo developed SET, a unique method of measuring signals in the presence of noise, and has licensed the SET technology to nearly half of the world’s patient monitoring companies.
“We’re convinced that Masimo SET technology is a breakthrough in pulse oximetry performance. Our members benefit not only from the competitive pricing, but also with cost savings from improved care, safety, and reduced liability,” said Bud Bowen, president of AmeriNet.
Joe E. Kiani, President and CEO of Masimo stated, “Working with AmeriNet has been a pleasure because they are truly committed to delivering on their promises to their members. AmeriNet realizes that they exist to serve their members and that, in the end, it’s all about patient care and safety. We are happy that AmeriNet has chosen to work with us and feel that their members will benefit greatly from access to Masimo SET, the new standard in pulse oximetry.”
Founded in 1986, AmeriNet, Inc., headquartered in St. Louis, operates through its three shareholder healthcare organizations: AmeriNet Central, Intermountain Health Care, Inc. and Vector. It represents 11,618 member facilities in all 50 states, including hospitals, medical group practices, nursing homes, surgery centers, managed care organizations, pharmacies and integrated delivery networks. This membership represents more than 317,300 health care beds. Additional information about AmeriNet can be found at www.amerinet-gpo.com.
TEWKSBURY, MASS. - A breakthrough development that sets a new standard in pulse oximetry will be available to a broad range of practitioners both inside and outside the hospital thanks to a partnership between Ohmeda Medical, Datex-Ohmeda Inc., and Masimo Corporation. Under the terms of the agreement announced today, Ohmeda Medical, Datex-Ohmeda Inc. and Datex-Ohmeda Continuing Care will distribute Masimo’s new Radical® Signal Extraction pulse oximeter in North America as a complement to their existing wide range of neonatal, acute care and continuing care products.
The Radical pulse oximeter, which was launched on February 12 at the Society for Critical
Care Medicine (SCCM) annual conference in Orlando, is the first end-user product developed by Masimo that uses the company’s standard-setting Signal Extraction Technology (SET). Masimo SET is a unique method for measuring signals accurately and reliably in the presence of patient motion and low perfusion, the two main challenges to pulse oximetry measurement. A chief advantage for both clinical and business customers is the“three-in-one” capabilities. It can be used as a bedside monitor or handheld oximeter, or it can upgrade existing multi-parameter monitors to Masimo SET through its SatShare™ interface.
Ohmeda Medical, a leader in perinatal and suction and oxygen therapy products and services, will distribute the Radical. Datex-Ohmeda Inc., a subsidiary of Datex-Ohmeda, a global leader in anesthesia equipment, will distribute the Radical through its North American and Continuing Care sales and distribution networks, serving customers both in- and outside-the-hospital care settings.
Richard Atkin, President of Datex-Ohmeda North America, commented: “We are pleased to make this pioneering technology available as part of our continuing mission to provide breakthrough solutions for our clinical and business customers. The Radical is an excellent fit for our North American distribution network because it meets our standards as a highly innovative product that is easy to use. It also expands the customer’s options because it works as a standalone or as an upgrade for other multi-parameter monitors. In addition, it can be used throughout the hospital for a wide range of patients as well as in patient care outside the hospital. Making Masimo SET Technology available to our customers through Radical advances our commitment to support acute and continuing care practitioners at every level.”
Andrew Krakauer, President of Ohmeda Medical, commented: “As an existing Masimo partner, we currently distribute several monitors featuring Masimo SET. Motion- and low perfusion-resistant pulse oximetry has clearly become the new performance standard and Masimo has been the pioneer of this advancement. We look forward to the addition of the Radical, the latest and most innovative product.”
Joe E. Kiani, President and chief executive officer of Masimo Corporation, said, “For years, motion artifact and low perfusion were the bane of pulse oximeters, forcing clinicians to live with false alarms and missed events. In 1989, Masimo invented Signal Extraction Pulse Oximetry, employing adaptive filter technology to extract the arterial signal from noise. When we unveiled this technology in the United States in 1998, it became a new standard of care because of its capabilities for tracking the patient’s physiology accurately, even under the most difficult conditions. The new Radical pulse oximeter gives hospitals and other care settings the option to convert to Masimo SET Technology by upgrading their existing oximeters.”
Kiani added, “Masimo’s focus is on technological breakthroughs. We needed a distribution partner for Radical who had the history, capability and desire to deliver on its promises to clinicians. We are very fortunate to find that combination in Ohmeda Medical and Datex-Ohmeda Inc. Datex-Ohmeda pioneered pulse oximetry in the United States and is not only one of the largest medical device companies in the world, but also one of the fastest growing patient monitoring companies. We look forward to a growing relationship with our new partners.”
Ohmeda Medical and Datex-Ohmeda North America will also carry Masimo’s full line of LNOP (Low Noise Optical Probe) sensors. Products will carry multi-brand labels.
Datex-Ohmeda pioneered the development of pulse oximetry and today is one of the worldwide leaders in pulse oximetry development, manufacturing and distribution. Datex-Ohmeda is committed to offering its customers the best affordable technology for anesthesia and critical care applications through its own proprietary technologies. In North America, Ohmeda Medical and Datex-Ohmeda Continuing Care also offer complementary products to meet the needs of special customer groups. Datex-Ohmeda is the core business of Instrumentarium Corporation (Nasdaq: INMRY; Helsinki: INSBV.HE), an international healthcare company headquartered in Finland. Instrumentarium’s net worldwide sales in 1998 were $728 million. It has approximately 4,300 employees worldwide. Datex-Ohmeda’s North American headquarters are located in Tewksbury, Mass. The company’s web address is www.datex-ohmeda.com. Ohmeda Medical is part of Datex-Ohmeda Inc. and has its headquarters in Columbia, Md. The web address is www.ohmedamedical.com
Innovative Monitor Enables Users to Easily Upgrade Existing Devices to Masimo SET Technology
Orlando, Florida, February 12, 2000 - Masimo Corporation today debuted its new “Radical” pulse oximeter during the Society for Critical Care Medicine (SCCM) conference in Orlando, Florida.
Radical is three pulse oximeters in one: a standalone device for bedside monitoring, a detachable handheld unit for easy portable monitoring and a monitor interface to upgrade existing multi-parameter patient monitors to Masimo SET technology. Radical can provide continuous and reliable arterial oxygen saturation monitoring anywhere throughout the continuum of care: EMS, during transport, in the ER, OR, ICU, recovery room, home, in any specialty clinic and the general floor. Radical delivers the unsurpassed accuracy and reliability of Masimo SET technology with multi-functionality, ease of use and a convenient upgrade path for existing monitors.
“Radical is our answer to the most common requests we get from clinicians after investigating Masimo SET technology,” stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “They clearly want the performance of Masimo SET, but they wish to have the Masimo SET pulse oximetry measurements integrated in their existing monitors. With Radical, we have given them a way to upgrade their instruments easily and inexpensively. The existing upgrade option for most multi-parameter monitors is to purchase an additional upgrade module. Radical’s Satshare™ feature allows the upgrade to be done without the additional module, which will save the end-user one to two thousand dollars for each unit. Many of the hospitals we are currently working with feel that Radical is the vehicle which will allow them to complete a whole-house conversion to Masimo SET technology, thus not only upgrading to the new performance standard but also benefiting from sensor standardization with our proven cost effective sensor family. Radical will be sold through some of our licensees and we expect to be announcing such new and expanded agreements soon.”
Irvine, California, February 3, 2000 - The Society for Critical Care Medicine (SCCM) has chosen Masimo Corporation as the recipient of this year’s SCCM Technology Excellence Award. This award, which recognizes outstanding strides in technology which benefit critical care medicine, will be formally given to Joe E. Kiani, Founder and President of Masimo Corporation, at the SCCM Conference to be held in Orlando, Florida from February 11 through February 15.
This is the first year such an award is being given to someone in the industry. The SCCM Awards had previously been given only to clinicians and non-industry researchers. According to the SCCM, “Masimo’s design convinced intensivists that pulse oximetry could work on the toughest patients and be useful during motion and low perfusion, thus raising the bar in the standards critical care medicine can now apply to future technology.”
“It is important that true technological innovators be recognized and rewarded for their efforts,” commented Max H. Weil, MD, PhD, FCCM, Distinguished University Professor and founder of the SCCM. “Prior to Masimo’s contributions, the false alarms and unreliability of pulse oximeters were assumed to be inherent and insurmountable limitations of the measurement. Masimo did not accept this and made an intuitive leap to create what is now the new standard of performance for pulse oximeters. Having dedicated my career to advancing the care of critically ill patients, I am happy to see that better care will result and the standards are being raised as a result of Masimo’s technological breakthrough. Masimo has truly earned this award.”
All Four Studies Conclude That Masimo SET Represents a Significant Advancement in Pulse Oximetry Performance
Irvine, California, January 16, 2000 - Four pulse oximetry motion studies were presented last week at the STA meeting held in Orlando, Florida. Three of the motion studies, on 8 subjects each, were conducted, at Mallinckrodt’s (Nellcor) facilities with Dr. Michael W. Jopling, MD, from Ohio State University, overseeing the studies. Dr. Michael W. Jopling and his co-authors, Paul D. Mannheimer and Donald E. Bebout, both from Nellcor, concluded, “The oximeter signal processing algorithms of the Nellcor N-395 (Oxismart XL) and IVY/Masimo SET appear to be a significant advance over the those of the Nellcor NPB-290 when pulse oximeter signals are corrupted by motion artifact.”
The fourth study was conducted by Dr. Steven J. Barker, PhD, MD, Professor and Chairman of Anesthesiology at the University of Arizona College of Medicine. The study was conducted at the University of Arizona College of Medicine on 50 subjects, comparing the performance of 16 pulse oximetry technologies, including Masimo SET and the Nellcor N-395, during motion. Dr. Barker concluded, “The Masimo SET pulse oximeter showed superior performance to the other units, in terms of both SpO2 and pulse rate accuracy and reliability.”
San Francisco, California, January 11, 2000 - Masimo Corporation today presented at the 18th Annual Hambrecht and Quist Healthcare Conference. Masimo, a privately-held medical technology company, is the pioneer of breakthrough signal processing technology for patient monitoring and the market leader of motion-resistant pulse oximetry. Masimo licenses its proprietary technologies to patient monitoring equipment manufacturers, profiting from royalties and the sale of its OEM products including printed circuit boards, disposable sensors and accessories. The first application of the Company’s Signal Extraction Technology is pulse oximetry, which is the noninvasive monitoring of arterial oxygen saturation and a recognized standard of care for patients at risk of hypoxemia. Industry sources estimate the worldwide market for pulse oximetry to be approximately $800 million.
Joe E. Kiani, President and CEO, reported that the Company continued to make significant progress in 1999 on all fronts.
Clinical Validation
Mr. Kiani told the audience that a dozen more independent clinical studies had been published in 1999, bringing the total to 24. All of these studies have shown that Masimo SET has overcome the limitations of conventional pulse oximetry, in terms of the high rate (up to 90%) of false alarms and the inability to detect true alarms during challenging conditions. Mr. Kiani stated, “Masimo SET has dramatically reduced false alarms, but what clinicians are most excited about is that Masimo SET is more sensitive in detecting true alarms, which conventional pulse oximeters miss today. Our aim was to create patient monitors for sick patients, not healthy engineers. We also believed that we needed to solve the fundamental signal-to-noise problems associated with in-vivo monitoring so that we would report physiology all of the time, including during motion, low perfusion, and other low signal-to-noise situations. By staying true to our goal, we have created a pulse oximeter that has not only reduced false alarms by over 90%, but is, in fact, more reliable in detecting true alarms on sick patients. That is why researchers have called Masimo SET the ‘foul weather friend’ and not the ‘fair weather friend’ that other pulse oximeters are today.”
Market Adoption
Mr. Kiani reported that the Company had signed worldwide licensing agreements with eight companies in 1999, bringing the total to 30. These 30 companies represent approximately 40% of all pulse oximetry shipments worldwide. The Company also announced that it has recently signed an agreement with one of the largest patient monitoring companies in the world and is in final negotiations with several others.
Mr. Kiani also pointed out that the industry is clearly moving towards requiring a new performance standard for pulse oximetry -- the performance standard that Masimo has pioneered. This is evident in recent standards bodies’ activities, revised end-user bid specifications and even in recent discussions in the legal community. Several articles have recently been published which discuss the liability associated with using inferior pulse oximetry technologies instead of Signal Extraction pulse oximetry.
1999 Results
Mr. Kiani stated that the Company’s revenues more than tripled in 1999. In 1999, the first full year of shipments since the first Masimo SET product was launched in the U.S. by Datascope in June 1998, the Company shipped approximately 12,000 OEM modules. This represents approximately one quarter of Mallinckrodt’s (Nellcor) reported shipments of 50,000 OEM modules. “We are delighted to see the clinicians’ fast rate of adoption of Masimo SET pulse oximetry and our partners’ strong sales activities,” commented Mr. Kiani.
New Products
Mr. Kiani also briefly discussed its recent acquisition of Vital Insite, Inc. “This acquisition will help us accelerate our plans for the launch of our new line of products in the area of continuous, noninvasive blood pressure (CNIBP) monitoring. It is widely thought, and many studies have confirmed, that significant fluctuations in blood pressure are highly correlated with heart attacks and strokes. To reduce these incidences, blood pressure must be measured and controlled continuously. Currently, continuous monitoring of blood pressure can only be reliably achieved with an arterial catheter, which is expensive and poses risk and discomfort to the patient. For these reasons, continuous, noninvasive blood pressure measurement is considered one of the most significant advancements still to be achieved in patient monitoring.” Mr. Kiani further added that the Company estimates the potential market for CNIBP products to exceed $1 billion annually.
Financing Plans
Masimo has raised over $60 million in private equity financing from some of the most respected names in healthcare investing. Masimo most recently closed on a mezzanine round for a total of $18 million in late 1999. The Company is planning on completing an IPO in 2000.
