|12/20/1999||Steven J. Barker PhD, MD, Presents Research Comparing Masimo SET to Sixteen Other Pulse Oximeters at the New York State Society of Anesthesiology Post Graduate Assembly (NYPGA)|
|12/10/1999||Masimo Corporation Announces Acquisition of Vital Insite|
|12/09/1999||Clinical Studies Involving Masimo SET™ Pulse Oximetry to be Presented at the Upcoming American Association of Respiratory Care (AARC) Conference|
|11/22/1999||Masimo Calls Mallinckrodt's Countersuit Predictable|
|11/22/1999||Dr. Christian Poets, World Renowned Neonatologist, Presents Research on New Developments in Pulse Oximetry at the 44th Annual Japan Society for Premature and Newborn Medicine Meeting|
|10/11/1999||Masimo Corporation Files Lawsuit Against Mallinckrodt|
|10/06/1999||Studies Confirm Masimo SET the Only Pulse Oximeter Evaluated Capable of Monitoring Blood Oxygenation on a Continuous Basis, an ASA Practice Standard for Ten Years|
|10/01/1999||Masimo Corporation Completes $18 Million Financing|
|08/31/1999||Dräger Medizintechnik GmbH and Masimo Corporation Announce Pulse Oximetry Purchasing and Licensing Agreement|
|08/05/1999||Masimo Corporation Announces Pulse Oximetry Purchasing and Licensing Agreements in Brazil|
|06/09/1999||Masimo Corporation Receives FDA Clearance for Performance Claims During Motion and Low Perfusion on All Patients, from Neonates to Adults|
|05/06/1999||MDE and Masimo Corporation Announce Pulse Oximetry Purchasing and Licensing Agreement|
|05/03/1999||New Study Shows a Significant Improvement in Pulse Oximetry Monitoring with Masimo SET™ Technology and Concludes that the Improved Performance Should Lead to More Timely Interventions and Possible Reduction in Complications Caused by Low and High Blood Oxygen Saturation Levels|
|03/31/1999||Alaris Medical and Masimo Corporation Sign Licensing Agreement|
|03/15/1999||Performance Advancements of Masimo SET Pulse Oximetry Highlighted at the 1999 International Anesthesia Research Society Congress|
|02/01/1999||New Published Neonatal Intensive Care Unit Pulse Oximetry Study Concludes that Masimo SET Technology Detects Hypoxemia and Bardycardia More Reliably Than Conventional Pulse Oximetry|
|01/28/1999||Masimo Corporation Announces Appointment of Julian M. Goldman, MD as Vice President of Medical Affairs|
Steven J. Barker PhD, MD, Presents Research Comparing Masimo SET to Sixteen Other Pulse Oximeters at the New York State Society of Anesthesiology Post Graduate Assembly (NYPGA)
"We may finally have a pulse oximeter that does what it’s supposed to do: provide accurate SpO2 measurements when we need them most"
Irvine, California, December 20, 1999 - Steven J. Barker, PhD, MD, Professor and Chairman of Anesthesiology at the University of Arizona College of Medicine, presented a new study at last week's NYPGA conference, held in New York City, comparing the performance of the newest pulse oximetry technologies during motion. This comparison study included the recently announced product from Mallinckrodt, the Nellcor N395 with Oxismart XL. The results confirmed that Masimo SET significantly outperformed all of the other 16 pulse oximeters tested, in terms of accuracy, reliable detection of hypoxemia and false alarm rate.
Dr. Barker's study is the first independent study comparing the Nellcor N395 (Oxismart XL) directly with Masimo SET. During mechanically controlled motions of experimental subjects' hands, Masimo SET correctly detected 98% of all actual hypoxemic events, compared with 63% for the Nellcor N395. The other instruments tested had highly variable detection and false alarm rates, but all were significantly worse in performance than Masimo SET.
Dr. Barker also showed examples of how Masimo SET tracked the test subject's oxygen saturation accurately during motion, while the other pulse oximeters did not. "Here are the Masimo and controls (SpO2 values) going down and back up, tracking each other quite nicely," commented Dr. Barker. "However, both the SpO2 and the heart rates displayed by the N200 and the N395 were fooled by the motion. The N200 and N395 displayed the rate of the motion, rather than the heart rate of the patient."
Later, when Dr. Barker was asked to comment on the accuracy claims that both Masimo and Nellcor are making during motion artifact, Dr.Barker replied, "Masimo SET received FDA clearance for accuracy during motion and low perfusion earlier this year, and our studies support Masimo's claims of ±3% accuracy during motion. However the bias and precision for the N395 during motion were -4.3% and ±5.6%, which does not support Nellcor's accuracy claims of ±3%, recently cleared by the FDA."
"The goal is to make the pulse oximeter, not just a fair weather friend, but also a foul weather friend," Dr. Barker continued. "The improvements with Masimo SET will decrease failures due to low perfusion, motion and other artifacts. I think Masimo's approach has been proven valid, and seems to be successful. We may finally have a pulse oximeter that does what it's supposed to do: give us accurate SpO2 measurements when we need them most."
Masimo Corporation Announces Acquisition of Vital Insite
Irvine, California, December 10, 1999 - Masimo Corporation today announced that it has acquired, for stock, the assets, including all intellectual property, of Vital Insite, Inc. Vital Insite was a development stage company which invested approximately $17 Million over that past several years developing a breakthrough technology for the continuous and noninvasive measurement for blood pressure (CNIBP).
It is widely thought, and many studies have concluded, 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.
“With our pulse oximetry business moving ahead nicely, we are ready to take on a new challenge,” stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “After listening to our customers, we decided to apply Masimo SET® to the measurement of blood pressure. We wish to make reliable blood pressure measurements available to clinicians on a continuous basis, noninvasively. Most clinicians we talked to say that CNIBP is one of the few ‘holy grails’ left in patient monitoring. The market for CNIBP should be at least one billion dollars. We select vital signs parameter projects that; have the potential to improve patient outcomes and reduce cost of care; have large markets; and have not been available because of ‘unsolvable’ technical issues. Continuous Noninvasive Blood Pressure fits that description perfectly.”
Mr. Kiani continued, “We were interested in Vital Insite’s Sonic Vibration Technology because their approach was very clever, yet it lacked certain necessary components inherent in our Signal Extraction Technology. We feel that by combining Sonic Vibration Technology with Signal Extraction Technology, we should be able provide a reliable CNIBP product to the market soon. We expect to continue with our business model of licensing. We plan to license our CNIBP technology to our partners in the patient monitoring industry, although some exclusivity may be granted up front to a development partner.”
Dave Schlotterbeck, President and CEO of Alaris Medical Systems and a Board Member of Vital Insite stated, “Vital Insite’s mission was to improve the standard of care with its CNIBP technology. The Board felt that Masimo was the best partner to accomplish that mission. Masimo has successfully addressed difficult monitoring problems. The proven Masimo SET technology represents a critical component in realizing a successful implementation of this extremely difficult clinical measurement.”
Clinical Studies Involving Masimo SET™ Pulse Oximetry to be Presented at the Upcoming American Association of Respiratory Care (AARC) Conference
"Masimo SET pulse oximetry reflected SaO2 (saturation) and ECG heart rate accurately and broad use should improve care."
Irvine, California, December 9, 1999 - Masimo Corporation today announced that three clinical studies on Masimo SET pulse oximetry will be presented at the American Association of Respiratory Care (AARC) conference in Las Vegas, Nevada from December 13 to December 16, 1999.
Ricardo Liberman, MD led a group of researchers at Huntington Memorial Hospital in Pasadena, California in a study to verify the accuracy and performance of Masimo SET technology on neonates during motion artifact. This study is the first of its kind because the researchers were able to attain excellent blood gas data during neonatal motion artifact. The researchers also evaluated the accuracy and performance of Mallinckrodt (Nellcor) N295 with Oxismart technology. The researchers concluded, "Motion adversely affects most pulse oximeters and spurious values can lead to inappropriate care. Conventional pulse oximeters, including Oxismart, performed much worse than their published accuracy specifications in this study. Masimo SET pulse oximetry reflected SaO2 (saturation) and ECG heart rate accurately and broad use should improve care."
Another team of researchers headed by Sally Harrington, RRT from the Kettering Medical Center in Kettering, Ohio performed a study that compared Masimo SET to the Nellcor N-200 on adult patients with lung disease during exercise testing. It has long been thought that motion and perfusion issues limit the use of pulse oximetry during exercise testing. The results showed that the Masimo unit was significantly more accurate and reliable than the Nellcor unit, with the Nellcor unit experiencing a drop-out rate more than 20 times that of the Masimo unit. These researchers concluded, "Use of conventional pulse oximetry during exercise testing is problematic. Motion and monitoring site hypoperfusion adversely affects conventional pulse oximetry performance. Our findings demonstrate that the Masimo SET pulse oximeter accurately reflects SaO2 and heart rate during exercise testing of adults with lung disease. Reliable pulse oximetry during stress testing can be achieved with Masimo SET."
Gary Russell, MD of Penn State University College of Medicine and his colleagues will present new data on performance of pulse oximeters, including the new Nellcor N-395 with Oxismart XL, during simulated motion artifact. Dr. Russell and his colleagues presented the first part of their study in October during the ASA conference which compared the Masimo SET technology to several other pulse oximeters including Hewlett-Packard, Criticare Systems, Novametrix, Nonin and Mallinckrodt (Nellcor). The results showed that the performance of the Masimo unit is significantly superior to all other monitors tested during both low and high frequency motion conditions. The researchers concluded, "The Masimo SET was the only pulse oximeter able to accurately report both SpO2 (saturation) and PR (pulse rate) during motion artifact."
Masimo Calls Mallinckrodt's Countersuit Predictable
Irvine, California, November 22, 1999 - Masimo Corporation calls the countersuit filed against the Company by Mallinckrodt predictable. Six weeks ago, Masimo filed a patent infringement lawsuit against Mallinckrodt and Nellcor for its infringing Oxismart XL pulse oximetry technology. Masimo is widely recognized as the technology leader in pulse oximetry.
"Mallinckrodt's lawsuit is part of a common pattern that infringers use to distract from their own infringement while attempting to make the plaintiff's suit as cumbersome, expensive and time-consuming as possible," stated Joe E. Kiani, President and CEO of Masimo Corporation. "Fortunately, we knew this could happen and were prepared for this type of reaction. Mallinckrodt will turn this lawsuit into an attorney check-writing campaign for as long as they can, but eventually the truth will win."
Mr. Kiani continued, "We value the international patent law system and have been careful to design our products respecting the patents of other companies. Anyone looking at the Masimo SET products can see the level of innovation and the uniqueness of our designs. Given Mallinckrodt's extensive patent portfolio, their assertion of three minor patents establishes how different and innovative Masimo's technology truly is. In fact, senior officials at Nellcor and Mallinckrodt have carefully reviewed our products for nearly seven years and never suggested our products might infringe their patents, and only now, in response to our patent infringement claims against them, do they seem to have a different opinion. In contrast, over a year before Mallinckrodt launched the MP404 and N395 (Oxismart XL), we warned Nellcor that they would infringe our patents and tried earnestly to provide Nellcor with a win-win solution. Nellcor simply ignored us and launched the Oxismart XL products anyway, giving us no choice but to file our lawsuit."
"The only surprising action that Mallinckrodt has taken is their attack on Ivy Biomedical, a customer of Masimo," commented Mr. Kiani. "To me, this is another act of desperation."
Dr. Christian Poets, World Renowned Neonatologist, Presents Research on New Developments in Pulse Oximetry at the 44th Annual Japan Society for Premature and Newborn Medicine Meeting
Masimo SET Pulse Oximetry Credited for Overcoming Problems Previously Considered Inherent in Pulse Oximetry
Okayama, Japan, November 22, 1999 - Dr. Christian Poets, world-renowned neonatologist from the Hanover Medical School, presented research that he and his colleagues have done on pulse oximetry at the 44th Annual Japan Society for Premature and Newborn Medicine Meeting in Okayama. Dr. Poets was invited to this meeting to discuss the clinical implications of Masimo SET. Dr. Poets presented the pitfalls of conventional pulse oximetry as well as the new advancements from Masimo Corporation, which have been shown clinically, to dramatically improve the reliability of pulse oximetry.
Dr. Christian Poets is Professor of Pediatric Pulmonology and Neonatology and Director of the Neonatal Intensive Care Unit at the Hanover Medical School in Hanover, Germany. Dr. Poets is also the co-chair of the Annenberg Conference, the international group working to reduce the risk of sudden infant death syndrome (SIDS) with newborn babies. Dr. Poets is well known for his research in transcutaneous oxygen monitoring and pulse oximetry. His most recent research is focused on the issues surrounding unreliable conventional pulse oximeters which miss critical, life threatening events and have high false alarm rates. Many studies have proven that conventional pulse oximetry is highly unreliable under motion artifact and low perfusion conditions. Dr. Poets has been investigating new technologies from several pulse oximetry manufacturers, and presented his research results on these products which claim to have improved performance under these conditions.
The data Dr. Poets presented compared Masimo SET pulse oximetry to Mallinckrodt's (Nellcor) Oxismart pulse oximeter. Dr. Poets noted while both oximeters claim to reduce false alarms, these two technologies operate very differently. Oxismart, from Nellcor, uses alarm management to hold alarms, if artifact is detected, for up to one minute before the unit will zero out and sound an audible alarm. On the other hand, Masimo SET does not use alarm management, but rather uses Low Noise Optical Probe, adaptive filter and Discrete Saturation Transform technology to read through the motion artifacts and low signal to noise situations in real time.
Dr. Poets then reviewed his published clinical studies performed on these technologies. He first discussed his study comparing Masimo SET to conventional pulse oximetry on neonates to determine if the frequency of alarms could be reduced. The results showed that there were 93% fewer alarms with Masimo SET as compared to the conventional pulse oximetry. Dr. Poets explained that these results were impressive, but another question still needed to be answered. Is this reduction in false alarms achieved at the expense of delayed or missed true alarms? To address this question, he and his colleagues performed a second study, which focused on the reliability of Masimo SET in detecting true alarms. This study also included Nellcor’s Oxismart technology for comparison. The results of this study showed that even though Masimo SET reduced alarm rates in the NICU by 93%, the Masimo SET technology was more reliable in detecting true alarms (true events of hypoxemia and bradycardia) than conventional pulse oximetry. Dr. Poets stated, “The Masimo SET instrument investigated in this study missed only one out of 185 (0.5%) hypoxemic episodes. In contrast, the other low alarm rate instrument investigated, the Nellcor Oxismart, failed to alarm in 10 (5.4%) episodes where there was definite hypoxemia for a long duration. Although the N200 alarmed during all of these hypoxemic episodes, during 15 hypoxemic events, it only alarmed because it had lost the signal and alarmed due to it zeroing out, which does not help clinicians make a clinical decision. The pulse oximeter’s ability to identify bradycardia differed even more widely, with more than 67% of episodes missed by the Nellcor Oxismart and 33% by the N200. The Masimo SET pulse oximeter again performed significantly better, missing only four out of 54 (7%) bradycardias.”
Dr. Poets also shared with the audience his preliminary impression of his current study under way, comparing Masimo SET with Oxismart XL and HP Veridia M3. Dr. Poets stated, “The Masimo SET still appears superior to these two new products, although further research is needed before more specific statements can be made.” Dr. Poets stressed that alarm management based products such as the Oxismart and Oxismart XL do not help clinicians take care of their patients. Dr. Poets commented, “Although SatSeconds, Nellcor’s new alarm management technique, may be acceptable for the home setting, it is not ideal for the NICU setting because NICU physicians often want to know about their patients’ physiology rather than just reduce alarms. In the NICU, we need to know the physiology of the patients, and Nellcor’s SatSeconds Alarm Management is not an acceptable way of reducing alarms. Masimo SET is advantageous because even though it reduces alarms by 93%, it doesn’t do that by ignoring physiological changes. The Signal Extraction Technology from Masimo measures the patient’s physiology accurately by extracting the signal fraught with noise.”
Another area of concern discussed by Dr. Poets was the problem of misapplied or misalligned sensors. Dr. Poets showed clinical data indicating that reusable sensors are more likely to cause this problem. Dr. Poets stated, “These less conformable sensors have the tendency to open up and come off the patients. In one case the conventional pulse oximeter with a reusable multi-site sensor reported erroneously high oxygen saturation even though the patient’s true arterial oxygen saturation was much lower. This had occurred because the sensor had opened up because of the inflexible material typically used in reusable probes. We refuse to use reusable sensors on our patients because of this increased risk.” Dr. Poets explained that, up till now, adhesive sensors had the disadvantage that they were more expensive than reusable sensors, but that Masimo now offers their LNOP single patient adhesive sensors, which not only offer optimal performance, but have been designed with greater durability to last longer and cost less. Dr. Poets commented, “A recent study found that the average longevity of these disposable sensors was twice that of their main competitor (Nellcor).”
“In summary,” Dr. Poets stated, “it appears from the data available to date, that some of the problems previously considered inherent to pulse oximetry, and thus apparently unsolvable, namely erroneous readings causing false alarms during motion and/or being due to low pulse pressures, have been greatly overcome by Masimo Signal Extraction Technology. Masimo SET should help pulse oximetry become the true ’foul weather’ friend we all need in our neonatal intensive care units. Masimo SET pulse oximetry should also allow us to better monitor babies at risk of SIDS by finally measuring their arterial oxygen saturation reliably without all the false alarms.”
Masimo Corporation Files Lawsuit Against Mallinckrodt
Irvine, California, October 11, 1999 - Masimo Corporation today announced that the Company has filed a patent infringement lawsuit in the Federal District Court in California against Mallinckrodt and Nellcor for its infringing Oxismart XL. Masimo has spent the last 10 years developing Signal Extraction Technology to solve the problems of pulse oximetry.
"In our 10 year history, we have never had any lawsuits. We had hoped to avoid litigation altogether." stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "Starting in 1989, Masimo pioneered Signal Extraction Pulse Oximetry, which permits monitoring in the presence of noise artifact, including patient motion. When we invented Signal Extraction Technology, inaccurate measurement due to motion artifact was considered an unsolvable problem and an inherent limitation of pulse oximetry. We were the first to prove that it is possible to monitor during motion. Twenty-one independent clinical study publications have proven our breakthrough performance. Our solution is based on a unique approach to the problem, which we patented."
Mr. Kiani continued, "We hoped that by making our breakthrough technology available to all patient monitoring companies, it would benefit patients, the community and industry. Although we have not seen any independent clinical studies proving Mallinckrodt’s performance claims with the Oxismart XL (MP404 and N395), we are disappointed that Mallinckrodt has chosen to use our patented technology without a license. Our investors, which include doctors and institutions, have invested over $60 million to help us fulfill our promise of continuous and accurate monitoring, even during motion and at times when the patient’s condition is most critical. If large companies, like Mallinckrodt, are allowed to simply use another company’s technology without a license, innovation through small companies would stagnate. Accordingly, despite our hesitation to litigate, we decided to enforce our intellectual property rights and file this patent infringement lawsuit against Mallinckrodt."
Masimo Corporation is a privately-held medical technology company that designs, develops and licenses advanced medical signal processing and sensor technology for the noninvasive monitoring of vital physiological parameters. Masimo has created a fundamentally unique method to measure arterial oxygen saturation and pulse rate. Masimo Signal Extraction pulse oximetry is the only technology clinically proven accurate during patient motion and low perfusion. To date, Masimo has licensed its Signal Extraction pulse oximetry OEM boards and proprietary single patient adhesive and reusable sensors to 30 international patient monitoring system providers which make up 40% of the world’s pulse oximeter shipments. Masimo is located in Irvine, California.
New Clinical Studies Involving Masimo SET Pulse Oximetry to be Presented at the Upcoming American Society of Anesthesiology (ASA) Conference
Studies Confirm Masimo SET the Only Pulse Oximeter Evaluated Capable of Monitoring Blood Oxygenation on a Continuous Basis, an ASA Practice Standard for Ten Years
Dallas, Texas, October 6, 1999 - Masimo Corporation today announced that new clinical studies on Masimo SET pulse oximetry will be presented at the American Society of Anesthesiology (ASA) conference in Dallas, Texas between October 10 and October 12.
Steven J. Barker, PhD, MD will present comprehensive data comparing the performance of 16 pulse oximeters, including Masimo SET. Dr. Barker led a research team from the University of Arizona to examine the most recent pulse oximetry technologies available at the time of this study, during patient motion. This study included pulse oximeters from Hewlett-Packard, Spacelabs, Datex-Ohmeda, Novametrix, Criticare Systems, Nonin, Smith Industries BCI and Mallinckrodt (Nellcor), including the Oxismart Alarm Management technology. The testing focused on specificity (probability of not alarming falsely) and sensitivity (probability of a true alarm condition being detected). The results showed a specificity value for the Masimo SET unit of 92% as compared to all other units, which averaged only 45%. The sensitivity (the ability to detect true alarms) results were similar, with the Masimo SET unit achieving 98% as compared to the other oximeters, which averaged only 50%. The researchers concluded, "Our results show clearly that the Masimo SET oximeter performs better during motion than the other units tested. This new technology should have a significant impact on critical care in all settings, particularly those in which patient motion is likely."
Another team of researchers, this time from the University of Michigan, headed by Shobha Malviya, MD and including Kevin Tremper, PhD, MD performed a study that compared Masimo SET to the Nellcor N-200 on children in the post anesthesia recovery room (PACU). 75 children were monitored for a total of 42 hours and the results showed that the Nellcor unit not only had more than twice as many false alarms as the Masimo SET unit, but missed 41% of the true hypoxemic events (true alarms) that lasted up to four minutes. The researchers concluded, "False alarms in pulse oximetry add to noise, waste nursing time, and desensitize caregivers to true alarm situations. Pulse oximeters containing Masimo SET can reduce the frequency and duration of false alarms in children in the PACU setting."
Gary Russell, MD of Penn State University College of Medicine led a group that performed two studies. In both studies, the researchers compared the Masimo SET technology to several other pulse oximeters including Datex-Ohmeda, Hewlett-Packard, Criticare Systems, Smith Industries BCI, Novametrix, Nonin and Mallinckrodt (Nellcor), including the Oxismart Alarm Management technology. The first study tested performance during simulated motion artifact where the results showed that all monitors tested, with the exception of Masimo, had bias greater than 10% during motion conditions and that most of these units, including the Nellcor Oxismart unit, had multiple instances where the monitor failed to read. The researchers concluded, "The Ivy 2000, with Masimo SET, was the only PO (Pulse Oximeter) able to accurately report both Sp02 and PR (pulse rate) during motion Artifact."
Dr. Russell’s second study tested the performance of these pulse oximeters under conditions of low perfusion, or a low amplitude pulse signal. The researchers focused on accuracy as well as time to alarm after a loss of pulse. The researchers concluded, "There was a significant difference in alarm delay. NPB 295 (Oxismart Alarm Management) took 120 seconds to sound alarm, but Ivy 2000 (Masimo SET) only 10 seconds. The Ivy 2000 with Masimo SET was the only oximeter to provide both accuracy during low perfusion and rapid detection of pulsatility loss."
"We once again thank these dedicated researchers for conducting this important research and publishing their results on behalf of their peers and patients," stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "So far, there have been more than 20 published studies which have shown conclusively that Masimo SET pulse oximetry is not only more accurate than conventional pulse oximetry under conditions of motion and low perfusion, but that Masimo SET is far less likely to miss an actual alarm condition. These results demonstrate that Masimo SET can be relied upon for the continuous monitoring of blood oxygenation, even during difficult conditions such as motion and low perfusion. The high level of false alarms, inaccurate readings and missed events exhibited by the conventional pulse oximeters in these studies will undoubtedly raise serious issues at this year’s ASA. Should these conventional pulse oximeters be relied upon to meet this 10 year old ASA practice standard now that Masimo SET is available?"
Masimo Corporation Completes $18 Million Financing
Irvine, CA, October 1, 1999 - Masimo Corporation today announced that it has raised $18 million through the sale of convertible preferred stock. Deutsche Banc Alex. Brown acted as placement agent for Masimo.
Masimo Corporation is a privately-held developer of proprietary signal processing and sensor technologies for medical applications. The first application of its technology is in pulse oximetry. 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 during patient motion, when the patient’s pulse is weak (low perfusion) or when the patient is very sick. The result has been a high rate of false alarms and failures, which reduces the usefulness of pulse oximetry when monitoring critically ill patients.
In 1989, Masimo invented Signal Extraction Pulse Oximetry, which enabled the use of adaptive filter technology to extract the arterial signal from noise. In 1998, Masimo unveiled this breakthrough technology to the world, and in June 1999, Masimo SET became the first and only pulse oximetry technology to receive FDA clearance for accuracy during motion and low perfusion conditions on all patients. Prior to the introduction of Masimo SET, pulse oximeters could only be relied upon for accurate measurement during ideal conditions. Today, after 5 years of clinical research, over 20 published clinical studies have shown that Masimo SET reliably and continuously tracks changes in arterial oxygen saturation and pulse rate, giving clinicians accurate monitoring when they need it most.
"We are pleased that we were able to successfully complete our mezzanine financing with new quality investors," stated Joe E. Kiani, Chief Executive Officer and Chairman of the Board of Masimo Corporation. "These new shareholders have joined us in our mission to introduce a new standard of performance to safely and cost effectively monitor patients. The market acceptance for Masimo SET pulse oximetry has been stronger than even we expected. In the past year and a half, 21 new companies, for a total of 30 patient monitoring companies that make up 40% of the pulse oximetry market, have committed to Masimo SET. We owe this successful mezzanine financing to these companies who, despite sensor standardization pressures, have partnered with us to champion a better way for the sake of their customers; to the caring clinical investigators, dedicated to better care on behalf of their patients and peers, who independently studied and published their clinical findings on the breakthroughs of Masimo SET technology; to our dedicated employees who have tirelessly stayed true to our mission; and to our current investors and Deutsche Banc Alex. Brown who have backed us up with timely financing and advice. This Team has been responsible for our strong momentum. On behalf of the Board of Directors, thank you!"
Dräger Medizintechnik GmbH and Masimo Corporation Announce Pulse Oximetry Purchasing and Licensing Agreement
Irvine, CA, August 31, 1999 - Dräger Medizintechnik GmbH (Lubek, Germany) and Masimo Corporation (Irvine, CA) announced a purchasing and licensing agreement under which Dräger will integrate Masimo Signal Extraction pulse oximetry technology into its future patient monitors which incorporate pulse oximetry.
Dräger Medizintechnik GmbH is a leading manufacturer of medical equipment worldwide. Dräger has earned a reputation of excellence in both product design and customer support.
Masimo Signal Extraction pulse oximetry is the only technology clinically proven accurate during patient motion and low perfusion. Numerous published studies have shown a virtual elimination of false alarms without sacrificing the ability to detect true alarms with Masimo Signal Extraction pulse oximetry, as compared with the other leading pulse oximetry systems.
"During Dräger’s long history, we have made one commitment to our customers, and that is to provide them with the best technology possible," stated Frank Rochlitzer, President of Dräger Medizintechnik GmbH. "We spent considerable time evaluating the performance of Masimo SET pulse oximetry and concluded that Masimo SET pulse oximetry would be an ideal choice for our future monitors and our customers."
Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "Dräger is widely recognized as one of the premier providers of medical equipment in the world. Just about everything they sell is considered best in its class and most people in the industry recognize Dräger as being synonymous with quality. After working with Dräger, I now understand how they achieved such a reputation. Their team is as solid a group of professionals that we have had the pleasure to work with. We are delighted to have Dräger as a partner."
Masimo Corporation Announces Pulse Oximetry Purchasing and Licensing Agreements in Brazil
Cabe and Omnitech Sign Agreements to Make Masimo SET Their Primary Pulse Oximetry Platform
Irvine, CA, August 5, 1999 - Masimo Corporation announced that it has signed licensing agreements with Cabe Ltda (Braganca Paulista, Brazil) and Omnitech Ltda (Belo Horizonte, Brazil) under which each will integrate Masimo Signal Extraction pulse oximetry technology as its primary pulse oximetry platform for its patient monitors.
Masimo Signal Extraction pulse oximetry is the only technology clinically proven accurate during patient motion and low perfusion. Numerous published studies have shown a virtual elimination of false alarms with Masimo Signal Extraction pulse oximetry, as compared with the other leading pulse oximetry systems, without sacrificing the ability to detect true alarms.
Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "South America is a key market which, to date, has received Masimo SET pulse oximetry through foreign sales divisions of some of our international licensees. Cabe and Omnitech are all led by progressive management teams who wish to provide the best medical equipment to their customers. We are delighted that they have chosen Masimo SET as their pulse oximetry platform and are looking forward to working with them to introduce monitors which will improve the standard of performance for pulse oximetry in South America."
Masimo Corporation Receives FDA Clearance for Performance Claims During Motion and Low Perfusion on All Patients, from Neonates to Adults
Masimo SET Becomes the Only Pulse Oximetry Technology Cleared by the FDA to Specify Accuracy During Motion and Low Perfusion Conditions
Irvine, CA, June 9, 1999 - Masimo Corporation announced that it has today received clearance from the FDA to expand the indications for use for its Signal Extraction Technology pulse oximetry system to include conditions of patient motion and low perfusion, on all patient populations. In addition, Masimo SET was also cleared for accuracy specifications under these conditions. No other pulse oximetry technology can make these claims.
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 during patient motion or when the patient’s pulse is weak (low perfusion). The result has been a high rate of false alarms and failures, 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 under conditions of motion and low perfusion. To date, there have been 16 independent, peer reviewed clinical studies published in prestigious journals which all conclude that Masimo SET pulse oximetry exhibits far fewer false alarms and failures (e.g., drop outs or zero outs), while being more reliable in detecting true alarms. This improvement is due to Masimo SET’s ability to accurately monitor under these difficult conditions.
"This is one more reassurance for those who are ready to adopt Masimo SET as the new performance standard for pulse oximetry," stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "We have had many published studies from leading clinical researchers like Dr. Steven Barker, Dr. William Hay, Dr. Christian Poets and Dr. Kevin Tremper showing Masimo SET’s superior performance. We have had numerous accounts by clinicians of Masimo SET’s ability to work whenever needed, which has resulted in their ability to better care for their patients. And now, we have FDA clearance for accuracy during motion and low perfusion on all patient populations. Our licensees are offering this technology worldwide; and the real beneficiaries will be the patients. I am proud of what our Team has accomplished."
MDE and Masimo Corporation Announce Pulse Oximetry Purchasing and Licensing Agreement
May 6, 1999 - Medical Data Electronics (MDE) and Masimo Corporation today announced a licensing agreement under which MDE will integrate Masimo Signal Extraction pulse oximetry technology as its primary pulse oximetry platform for its current and future patient monitors.
Masimo Signal Extraction pulse oximetry is the only technology clinically proven accurate during patient motion and is designed for accuracy during conditions of low perfusion, bright ambient light and electro-surgical interference. Numerous published studies have shown a virtual elimination of false alarms with Masimo Signal Extraction pulse oximetry, as compared with the other leading pulse oximetry systems, without sacrificing the ability to detect true alarms.
"We first became aware of Masimo about two years ago," stated Drew Rogers, President of MDE. "It was obvious they had significantly improved the performance of pulse oximetry and that it would be a great enhancement to our monitors. After extensive due diligence and testing of the Masimo technology and after receiving numerous requests from our customers, we decided to commit to making it our standard pulse oximetry platform. Over the last few months, there has been an increasing level of requests from our customers to offer Masimo SET in our monitors. This has confirmed that our decision to go with Masimo will not only improve patient care but also result in increased monitor sales."
Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "MDE has an excellent reputation in the market. Their Escort multi-parameter monitor series is a leading product in the industry and their new color Prism multi-parameter series promises to make them a player at the next level. They also have one of the most technically competent management teams and sales forces that we have dealt with so far. We are delighted to have MDE as a partner."
MDE has been a consistent leader in monitoring for over 20 years, focusing on the development of innovative, state-of-the-art monitoring solutions. MDE has been a pioneer in portable, wireless patient monitoring systems. MDE’s mission is to remain the leading source of innovations in cost-effective patient monitoring technology that supports better, more efficient healthcare delivery. MDE is a wholly owned subsidiary of Thermo Electron -- a world leader in analytical and monitoring instruments and a major producer of biomedical products, paper recycling equipment and alternative-energy systems. Thermo Electron’s Biomedical Group, which comprises more than 20 individual operating units, sells medical devices directly to hospitals, physicians and other care providers. The focus of this group includes critical-function physiological monitoring, products for cardiovascular and hematology treatment, X-ray imaging, respiratory care, and state-of-the-art analytical systems that perform vital tasks in the research and development of new medical treatments and pharmaceutical products. Additional information concerning MDE can be found at its web site, at www.MDESolutions.com.
New Study Shows a Significant Improvement in Pulse Oximetry Monitoring with Masimo SET™ Technology and Concludes that the Improved Performance Should Lead to More Timely Interventions and Possible Reduction in Complications Caused by Low and High Blood Oxygen Saturation Levels
Sunday, May 2, 1999, San Francisco, California: At the Pediatric Academic Societies’ annual meeting, a new study entitled "Pulse Oximetry in the NICU: Conventional vs. Masimo SET" (Pediatric Research: Apr. 1999; Vol. 45; Page 304A) was presented. The study concluded that there was a significant decrease in false alarms with Masimo SET pulse oximetry as compared to the market leading conventional pulse oximetry manufactured by Mallinckrodt’s Nellcor Puritan Bennett division. The study also showed that Masimo SET was more reliable in detecting true alarm conditions than the conventional technology and that the performance improvement should lead to more timely clinical interventions and possible reductions in hypoxic and hyperoxic pathology. The study was conducted by William W. Hay Jr., M.D., Professor of Pediatrics at the University of Colorado Health Sciences Center.
The study was performed in the neonatal intensive care unit (NICU) and included 156 total hours of monitoring time on 26 babies. The results showed an 86% reduction in false alarms and a 92% reduction in false alarm duration with Masimo SET pulse oximeter as compared to the conventional pulse oximeter. The results also showed a six-fold improvement in detection of true bradycardic events with the Masimo SET technology.
"Pulse oximetry is routinely used in the NICU to monitor the neonate’s oxygenation status," stated William W. Hay Jr., M.D. "However, it has a high false alarm rate that, to date, has been a nuisance to caregivers and parents. Indeed, there is evidence that the "crying wolf" syndrome caused by conventional pulse oximetry leads to decreased response to alarms. In addition, the inaccurate and potentially misleading under-reading of SpO2 caused by motion artifact may lead to inappropriate oxygen titration. This could have detrimental effects for this neonatal population at risk for ROP (retinopathy of prematurity) and pulmonary hypertension"
Dr. Hay continued, "Our results are consistent with others in showing increased accuracy during motion and marked reduction in false alarms. Masimo SET should be useful in improving the titration of oxygen in infants in the NICU, which could be critical in the prevention of ROP and the management of PPHN (persistent pulmonary hypertension of the newborn) and CLD (chronic lung disease). This technology should allow accurate assessment of supplemental oxygen needs in infants at discharge. In addition, decreased audible false alarming should have a beneficial effect on caregivers, parents and neonates."
"It is gratifying to have clinical studies, one after another, conclude that Masimo SET has improved the reliability of pulse oximetry," stated Joe E. Kiani, President and CEO of Masimo Corporation. "Having clinicians with Dr. Hay’s accomplishments conclude that the improved performance from Masimo SET pulse oximetry not only reduces false alarms but could improve patient care and outcomes, which is what really matters, makes our 10 years of research and development worthwhile".
Alaris Medical and Masimo Corporation Sign Licensing Agreement
ALARIS Medical Will Incorporate Masimo SET® Pulse Oximetry into its First Generation Modular Patient Care System
SAN DIEGO, CA, March 31, 1999 -- ALARIS Medical, Inc. (NASDAQ: ALRS) and Masimo Corporation today announced a licensing agreement under which ALARIS Medical plans to integrate Masimo Signal Extraction pulse oximetry technology into its first generation Modular Patient Care System. ALARIS Medical, through its wholly owned subsidiary, ALARIS Medical Systems, has been developing an innovative Patient Care System designed to enhance patient safety by reducing point-of-care medication errors through the integration of infusion therapy and patient monitoring.
Adverse reactions to prescription drugs are the fourth leading cause of death nationally. With a significant market share of all U.S. hospital beds, ALARIS Medical is well positioned to reduce medication errors related to infusion therapy with the introduction of its Patient Care System. ALARIS Medical believes the use of Masimo SET pulse oximetry technology, with ALARIS Medical’s Patient Care System, will help establish a new standard for patient safety.
"As a global leader in the development of infusion therapy systems, we wanted state-of-the-art pulse oximetry technology for our first generation Patient Care System," said William J. Mercer, ALARIS Medical President & CEO. "Pulse oximeters are used in a variety of situations, but are of particular value for monitoring oxygenation and pulse rates during the delivery of certain anesthetic agents. In every application, accuracy and reliability are critical. Our due diligence, along with published clinical research, indicates that Masimo is rapidly becoming a technology leader in pulse oximetry. We’re very impressed with this company and are pleased to partner with them in establishing a new standard of patient care," he added.
"ALARIS Medical’s Patient Care System is being designed to enhance patient safety by reducing point-of-care medication errors through the integration of infusion therapy and patient monitoring," said Robert S. White, ALARIS Medical Corporate Vice President of Business Development. " Masimo has created a novel approach to measure arterial oxygen saturation and pulse rate with significant clinical accuracy even in the presence of high levels of interfering signals or motion artifact. The integration of pulse oximetry into the ALARIS Medical Patient Care System demands the highest level of clinical accuracy. We felt Masimo was the only choice."
"Over the past 30 years, ALARIS Medical’s thermometers and infusion pumps have revolutionized and improved how patients are cared for today," said Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "ALARIS Medical is once again redefining how infusion of therapeutics and pain relief should be delivered. This is not only an important relationship for the two companies, but I believe it is truly significant for patient care. We are delighted that we can, with Masimo SET pulse oximetry, assist ALARIS Medical in improving patient outcomes."
ALARIS Medical, Inc., through its operating company, ALARIS Medical Systems, Inc., is known for its IMED® and IVAC® brand names of intravenous infusion therapy systems and Instromedix® cardiac event recorders and pacemaker follow-up systems. The Company’s principal line of business is the design, manufacture and marketing of intravenous infusion therapy products, patient monitoring instruments and related disposables. The Company’s products are distributed to more than 120 countries worldwide. In addition to its San Diego world headquarters and manufacturing facility, the Company also operates manufacturing facilities in Creedmoor, NC; Hillsboro, OR; Basingstoke, Hampshire, UK; and Tijuana, Mexico. Additional information on ALARIS Medical can be found at www.alarismed.com.
Performance Advancements of Masimo SET Pulse Oximetry Highlighted at the 1999 International Anesthesia Research Society Congress
March 15, 1999 - Masimo SET pulse oximetry was credited as a key scientific advancement in Dr. Steven Barker’s presentation entitled "New Developments in Oxygen Transport and Monitoring" at the Seventy-Third Clinical and Scientific Congress of the International Anesthesia Research Society (IARS) in Los Angeles, California. Dr. Barker is the Chairman of the Department of Anesthesiology at the University of Arizona and has published numerous studies on patient monitoring including several on recent developments in the area of pulse oximetry.
In his presentation, Dr. Barker discussed the evolution of oxygen monitoring and the relative importance of the advent of conventional pulse oximetry nearly 20 years ago. "Pulse oximetry is one of the greatest breakthroughs in monitoring in the 20th century," stated Dr. Barker. "You would be an absolute fool to do either general or regional anesthesia without pulse oximetry on every patient."
Dr. Barker pointed out that, as valuable a measurement as it is, conventional pulse oximetry has been plagued by significant shortcomings. He told the audience that the most significant weaknesses are the inability to give accurate readings during patient motion and low arterial perfusion. "When used in the OR and critical care units, conventional pulse oximeters are limited by the fact that they often fail to provide accurate data at the most critical times," commented Dr. Barker. To prove this point, he presented the results from another researcher’s study conducted in 1992 involving more than 10,000 patients which concluded that the incidence of pulse oximetry failures increased dramatically with the level of patient accuity. "This study shows us that the failure rate goes up very drastically as the patients get sicker." "That has lead some of us to call the pulse oximeter a fair-weather friend. It tends to work just fine when everything is O.K., but when things are going bad, that’s when it is most likely to fail."
Dr. Barker then talked about recent developments aimed at improving the reliability of pulse oximetry. He explained the theory behind Masimo SET Signal Extraction pulse oximetry to the audience. "Masimo SET is a totally different way of calculating saturation," commented Dr. Barker. "Masimo SET is the first significant advancement in pulse oximetry since the introduction of pulse oximetry." He shared with the audience the results of several studies he had previously conducted and published which showed significant improvement with Masimo SET as compared to conventional pulse oximeters. In one of these studies, published in Anesthesiology in 1997, comparing Masimo SET against Nellcor’s new Oxismart technology, he told the audience that the Masimo unit had zero false alarms while catching all true alarms, as compared to Oxismart which had 36% false alarms and missed 16% of the true alarms. "With Masimo SET, we can now rely on pulse oximetry at all times, especially when you need it most." "Masimo SET should clearly become the new standard for pulse oximetry."
New Published Neonatal Intensive Care Unit Pulse Oximetry Study Concludes that Masimo SET Technology Detects Hypoxemia and Bardycardia More Reliably Than Conventional Pulse Oximetry
February 1, 1999 - A new clinical study entitled "Pulse Oximeters’ Reliability in Detecting Hypoxemia and Bradycardia: Comparison Between Nellcor N-200, N-3000 and Masimo SET" (Pediatric Pulmonology: Dec. 1998; Page 444) was presented last week at the 17th Annual Conference on Sleep Disorders in Infancy and Childhood at the Annenburg Center for Health Sciences in Rancho Mirage, California. The study concluded that Masimo SET pulse oximetry was more reliable in detecting hypoxemic and bradycardic episodes in infants than conventional pulse oximeters manufactured by Mallinckrodt’s Nellcor Puritan Bennett division. 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.
Dr. Poets had previously published a study where he 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 (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, while the other low-alarm-rate instrument (Masimo SET) identified both conditions equally or even more reliably than a conventional pulse oximeter (N-200)".
Masimo SET’s ability to substantially eliminate false alarms is critical to making pulse oximeters useful safety monitors. 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, stated Joe E. Kiani, President and CEO of Masimo Corporation. "Dr. Poets’ studies have shown that Masimo accomplished its mission by not only dramatically reducing false alarms, but by being even more reliable in detecting true alarms than the N200 pulse oximeter, which has been used by hospital for more 10 years. We hope that this will result in better patient care."
Masimo Corporation Announces Appointment of Julian M. Goldman, MD as Vice President of Medical Affairs
January 28, 1999 - Masimo Corporation (Irvine, CA) today announced the appointment of Julian M. Goldman, MD as Vice President of Medical Affairs. In addition to his other responsibilities, Dr. Goldman will work with independent researchers to expand the clinical evaluations of Masimo SET pulse oximetry.
Dr. Goldman left his position as a tenured anesthesiologist at the University of Colorado to join Masimo. As Director of Anesthesia Research, Dr. Goldman has been performing research in monitoring and artificial intelligence applications in anesthesia, as well as teaching anesthesia to resident physicians, and clinical care. Dr. Goldman is currently chair of the National Anesthesia Equipment Standards Committee and has been involved in numerous other national and international anesthesia teaching and society activities.
"I was impressed with the Masimo SET pulse oximetry technology from the first time I saw a demonstration," stated Julian M. Goldman, MD. "It obviously monitored during patient motion and low perfusion, which is something no other pulse oximeter can do. But, it wasn’t until I personally tried the unit on a patient that no other pulse oximeter could work on that I fully realized the implications this technology would have on improving the care of patients at risk of hypoxemia. This led me to the decision to leave clinical practice and join Masimo. As an anesthesiologist, I’ve dedicated my career to improving patient care. Now, at Masimo, I feel I can have an even greater impact by creating breakthrough medical technologies that substantially improve the level of care."
"Julian is a key addition to our management team," stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "We have an excellent team that believes that there are no unsolvable problems. This team has created a revolutionary technology that has overcome what have been thought to be inherent limitations of pulse oximetry. Now we believe it is our responsibility to make sure that clinicians responsible for the care and safety of patients become aware of the availability and clinical implications of Masimo SET pulse oximetry. Julian’s clinical stature, appreciation for the role of technology in medicine and desire to improve patient care make him the perfect candidate for this critical role."
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