Masimo Corporation Announces Introduction of Low Power Signal Extraction Pulse Oximetry Printed Circuit Board

December 2, 1998 - Masimo Corporation (Irvine, CA) reported that it has completed development and testing of a new low power pulse oximetry printed circuit board. This product is now in full production and is commercially available to Masimo’s licensees. The product, which is named the MS-3, utilizes approximately one watt, which is less than half the power of its first board, MS-1, but is offered to Masimo’s licensees at the same price as MS-1.

Masimo has recently introduced its proprietary Signal Extraction pulse oximetry technology and follows a strategy of licensing this technology to established and innovative patient monitoring companies worldwide. Masimo Signal Extraction pulse oximetry signal processing software resides on a printed circuit board which is offered to its licensees for incorporation into their monitors.
Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "MS-3 represents a significant engineering effort. The Signal Extraction Technology that we developed which enables adaptive filters to cancel in-band noise, such as noise due to motion artifact, involves a much higher level of number crunching than the red over infrared signal processing in conventional pulse oximetry. With MS-3, we are now able to deliver the Masimo SET level of processing at a lower power consumption level than many conventional pulse oximeters. The MS-3 board will enable reliable monitoring in critical transport situations where motion artifact and other interferences, such as intense light, are most prevalent."

Masimo Corporation designs, develops and licenses advanced medical signal processing and sensor technology for the noninvasive monitoring of vital physiological parameters. Masimo, a privately held company, 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 is designed for accuracy during conditions of low perfusion, bright ambient light and electro-surgical interference. Masimo currently licenses its Signal Extraction family of pulse oximetry products to over 20 international patient monitoring instrument providers with whom share revenue from the sale of Masimo’s proprietary sensors. Masimo is located in Irvine, California.

New Published Neonatal Intensive Care Unit Study Shows That Masimo SET Pulse Oximetry Single Patient Adhesive Sensors Last Nearly Twice as Long as The Market Leading Adhesive Disposable Sensors

November 9, 1998 - A new clinical study entitled "Useful Life of Pulse Oximetry Sensors in the NICU" (Respiratory Care 1998; 48 (10): 860) was presented today at the 44th International Respiratory Congress in Atlanta, Georgia, which concluded that Masimo's adhesive sensors lasted nearly twice as long as the market leading adhesive sensors which are manufactured and distributed by Nellcor Puritan Bennett. The study was conducted by Alison Thomas, BSN, Michael Holmes, BS, RRT, John Vogt, MD, Ernesto Gangitano, MD, Carolina Stephenson, MD, Richardo Liberman, MD at the Department of Neonatology, Huntington Memorial Hospital, Pasadena, CA.

The study included 16 sick newborns in a neonatal intensive care unit (NICU) which had both Nellcor N-25 and Masimo LNOP Neo sensors attached. There were 56 sensors used for a total of 211 days. This hospital had previously used the Nellcor sensors exclusively and thus had substantial experience with those sensors. Data was recorded regarding start times, times sensors were replaced or removed and the reasons for the replacement or removal. The results showed the following: number of sensors used, Masimo 19, Nellcor 37; average sensor life (days), Masimo 11.1, Nellcor 5.7; percent of sensors lasting entire patient stay, Masimo 81%, Nellcor 6%. The researchers concluded that, "If the sensor cost to the hospital was identical, a nearly twofold savings could be realized with the Masimo neonatal pulse oximetry sensors."

Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "That our Mission has been to help improve patient outcome and reduce cost of care. This latest published study is gratifying to us all because it shows that we have made great strides towards our Mission. Masimo SET pulse oximetry has been clinically shown to give continuous accurate measurement of arterial oxygen saturation and pulse rate, which should by itself help reduce cost of care due to reduction of associated costs of dealing with loss of monitoring or false measurements and alarms. Published intensive care unit studies have shown that 70%-90% of the conventional pulse oximetry alarms are false alarms due to motion artifact and low perfusion. Numerous published studies have shown a virtual elimination of false alarms with Masimo Signal Extraction pulse oximetry, without sacrificing the detection of true alarms. Although Masimo and its partners could probably have charged a premium for this advancement, we decided to offer both the Masimo SET pulse oximeters and Masimo SET sensors at the same price as conventional pulse oximeters and sensors. We chose such a pricing strategy so that clinicians will be able to get Masimo SET pulse oximeters for the benefit of their patients without having to overcome cost justification. The cost savings data presented at this years American Association for Respiratory Care should make it even easier for clinicians to get a pulse oximeter that they can rely on."

Masimo Corporation Announces Agreement with Allegiance to Distribute Pulse Oximetry Products

October 22, 1998 - Masimo Corporation (Irvine, CA) announced today an agreement under which Allegiance Healthcare Corporation (McGaw Park, IL) will include Masimo's pulse oximetry signal processing and sensor technologies in a line of monitors to be offered in its Best Value program.

Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has created a fundamentally advanced 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 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 look for outstanding products for our Best Value program which are the best in their class and priced to meet the cost management goals of today's healthcare providers," said Tony Kesman, Corporate Vice President for Allegiance's distribution business. "Masimo's pulse oximetry products fit this model perfectly. We are very excited about offering these new pulse oximetry products to our customers."

Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "We are delighted to add Allegiance as a partner. Allegiance's incredible distribution network will virtually guarantee that any clinician that needs Masimo SET pulse oximetry can get it."

Based in McGaw Park, IL, Allegiance Healthcare Corporation is the principal U.S. operating subsidiary of Allegiance Corporation (NYSE:AEH). Through its subsidiaries, Allegiance is America's leading provider of health-care products and cost-management services needed by hospitals, laboratories and others in health care. The company manufactures many of the products it markets, while others come from leading health and medical companies around the world. Allegiance also provides a range of integrated services such as clinical and productivity consulting, procedure-based supply packaging, just-in-time delivery and other services that help medical professionals control costs and improve quality in patient care. For more information about Allegiance, visit its web site at www.allegiance.net.

Masimo Signal Extraction Pulse Oximetry Debuted at the American Society of Anesthesiology Conference

October 14, 1998 - Masimo Corporation (Irvine, CA) announced that its breakthrough Signal Extraction^™ pulse oximetry will be demonstrated at the upcoming meeting of the American Society of Anesthesiologists which will be held in Orlando, Florida (October 18 – 21). The Company plans to have its technology and products on display at its own booth as well as at the booths of several of its licensees. The Company will also be sponsoring a symposium regarding the clinical implications of Masimo SET^® pulse oximetry on October 15.

Masimo, a medical technology company, has created a fundamentally advanced method of measuring arterial oxygen saturation and pulse rate. 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 conventional pulse oximetry, without sacrificing the ability to detect true alarms. In one such study published in the Journal of Anesthesiology, Dr. Steven Barker, Chairman of the Dept. of Anesthesiology at the University of Arizona, and Dr. Nitin Shah at the University of California, Irvine reported that, under conditions of motion, Masimo SET had no false alarms while catching all of the true alarms as compared to the latest conventional pulse oximeter (Oxismart - N290, N295 & N3000) manufactured by Nellcor which false alarmed 36% of the time and missed 16% of the true alarms.

"Masimo SET is the first significant advancement in pulse oximetry since the introduction of pulse oximetry," stated Steven Barker, Ph.D, M.D. "Masimo SET should clearly become the new standard for pulse oximetry."

The Company has a business strategy of licensing its technology to leading patient monitoring companies in an effort to rapidly improve the standard for pulse oximetry measurement. The Company believes that by offering a clearly superior product without charging a price premium over existing products, it offers clinicians the opportunity of improving patient care while reducing cost through truly reliable monitoring and durable adhesive sensors. To date the Company has signed licensing agreements with more than one quarter of the world's suppliers of pulse oximetry. Several of the Company's licensees have recently launched products with Masimo SET pulse oximetry and several others are due to launch by year end.

Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "Over the last 15 years, clinicians have learned to accept the shortcomings of conventional pulse oximetry. Signal degradation due to motion artifact and low perfusion were assumed to be insurmountable limitations of pulse oximetry. We have solved these problems and now offer a pulse oximetry technology that does what it is supposed to do – reliably monitor the patient."

"Masimo has a very solid technology and strategy," stated Jonathan Osgood, Managing Director and medical device analyst for BT Alex. Brown. "Masimo is offering a product which is certain to improve the quality of care and decrease the cost of care as well. This is a rare and impressive combination which is why I believe that many of the leading patient monitoring companies are adopting Masimo SET as their standard pulse oximetry product."

The Company's plans for the ASA include live demonstrations of its technology in its booth and several of its licensees' (Allegiance Healthcare, Cardiopulmonary Corporation, Datascope Corporation, and Invivo Research) booths as well as sponsoring a clinical symposium. The symposium, which will be held on October 15 from 6:30 – 8:30 at the Clarion Plaza hotel in Orlando, will focus on the clinical implications of Masimo Signal Extraction pulse oximetry. The speakers are world renowned clinical researchers, Jeremy Swan, Ph.D., M.D., Steven Barker, Ph.D., M.D., Christian Poets, M.D. and Kevin Tremper, Ph.D., M.D. known for their contribution to the field of medicine.

GS Electromedical Forms Pulse Oximetry Purchasing and Licensing Agreement With Masimo

April 29, 1998 - GS Electromedical (Kaufering, Germany) and Masimo Corporation (Irvine, CA) today announced an agreement under which GS Electromedical will integrate Masimo’s pulse oximetry signal processing and sensor technologies into its current and future defibrillators/monitors that include pulse oximetry. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has created a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of motion artifact.

Gunter Stemple, President of GS Electromedical, stated, "Our primary products are defibrillators and monitors used in emergency medical applications. In these applications, the current pulse oximetry technology has proven to be largely ineffective due to problems caused by patient motion, low perfusion and ambient light. We believe that Masimo has effectively solved these problems and has thus created a new standard of performance for this vital measurement. We are happy to be one of the first companies in our market to be able to offer our customers this quantum leap in performance and reliability."

Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "Conventional pulse oximetry brings little or no value in the emergency medical application due to its inability to give reliable arterial blood oxygen saturation and pulse rate measurement under these challenging conditions. We are delighted that the people at GS Electromedical have recognized the shortcomings of conventional pulse oximeters and have embraced Masimo SET pulse oximetry for the benefit of patient care."

GS Electromedical designs, manufactures and distributes defibrillators and other equipment used primarily in emergency medical applications. GS Electromedical is located in Kaufering, Germany and primarily serves the European market.

Kohken Medical Forms Pulse Oximetry Purchasing and Licensing Agreement With Masimo

April 14, 1998 - Kohken Medical (Tokyo, Japan) and Masimo Corporation (Irvine, CA) today announced an agreement under which Kohken will integrate Masimo’s pulse oximetry signal processing and sensor technologies into its current and future patient monitors that include pulse oximetry. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has created a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of motion artifact.

Eiichi Matsui, President of Kohken Medical, stated, "We are looking forward to including Masimo SET^® technology in our patient monitors. This is a significant advancement over previous pulse oximetry technologies and will address the many complaints from clinicians regarding the pulse oximeter’s inability to work effectively under conditions of patient motion or low peripheral blood flow. By incorporating Masimo SET pulse oximetry technology, we will be offering a higher level of care for patients at risk of respiratory problems. We expect to have a long and fruitful relationship with Masimo."

"I am very honored to have Kohken become Masimo’s newest partner," stated Joe E. Kiani, President and Chief Executive Office of Masimo Corporation. "Kohken is a quality company with an outstanding reputation and we are looking forward to working with them. This is our eighth such announcement in recent months and we are very pleased and excited by the accelerating adoption of Masimo SET as the new standard in caring for patients at risk of respiratory complications."

Kohken Medical designs, manufactures and distributes medical devices for the Japanese market. Kohken’s major areas of expertise are in emergency transport, and adult, neonatal and pediatric respiratory monitoring.

Invivo Research and Masimo Corporation Announce Pulse Oximetry Purchasing and Licensing Agreement

February 24, 1998 - Invivo Research (Orlando, FL) and Masimo Corporation (Irvine, CA), today announced a licensing agreement under which Invivo will integrate Masimo's pulse oximetry signal processing and sensor technologies into its current and future patient monitors that include pulse oximetry. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has created a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of motion artifact.

Roger Susi, Founder and President of Invivo Research, a subsidiary of Invivo Corporation, stated, "We are always looking to include the best possible technology in our products. It has become clear to us through published clinical studies and our own analysis that the Masimo SET^® Technology offers a significant improvement over the conventional pulse oximetry technology. We are betting that Masimo SET will become the expected standard for pulse oximetry measurement in the future."

"I am very proud to add Invivo as a partner," stated Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "Invivo is an aggressive and innovative company that is committed to being on the forefront of technology in order to provide the best possible products to its customers. We are looking forward to working with Invivo for many years to come."

Invivo Corporation designs, manufactures and markets proprietary medical devices for patient vital sign monitoring in a variety of applications inside and outside of the hospital. Major markets include Radiology/MRI, Operating Rooms, Post Anesthesia Care Units, Emergency Rooms, Labor and Delivery Suites, Critical Care Units, Step-down Areas and Special Procedural Areas.

Datascope Corp. and Masimo Corp. Announce Expanded Licensing Agreement

February 19, 1998 - Datascope Corp. (Montvale, NJ) and Masimo Corporation (Irvine, CA), today announced a new licensing agreement which replaces the current agreement between the companies. The new agreement provides for integration of Masimo's proprietary pulse oximetry technology, Masimo SET^®, into Datascope's current and future patient monitors. Additionally, Datascope has acquired a license to use Masimo's proprietary pulse oximetry sensors with Datascope's monitors which are already in use. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has created a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of motion artifact.

"We originally entered into an agreement with Masimo because of our positive evaluation of Masimo's breakthrough technology and our belief that Masimo SET would eventually become the new standard in pulse oximetry," stated Lawrence Saper, Chairman and CEO of Datascope Corp. "After working more closely with Masimo, we confirmed our initial conclusions regarding the clinical advantages of the technology and decided to rely on Masimo, even more, to provide the solutions for our needs in the area of pulse oximetry."

Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, "Datascope's decision to strengthen its commitment to Masimo, after working together for nearly two years, is very gratifying. Not only does this speak to the strength of our technology but also to the commitment of our people to our partners. Datascope has an unusually high breadth and depth of talented people from the very top of the organization to the engineers and sales people. We are especially proud of our relationship with Datascope and our extended agreement."

Datascope Corp. manufactures proprietary products for clinical healthcare markets in interventional cardiology, anesthesiology, critical care and cardiovascular, vascular and general surgery. The company's products, including the Passport, Accutorr and Point of View patient monitors, are distributed world-wide. Datascope is headquartered in Montvale, New Jersey.

Masimo Corporation Completes $18.2 Million Financing

February 3, 1998 - Masimo Corporation (Irvine, CA) today announced that it has raised an additional $5.1 million through the sale of convertible preferred stock. This brings the total raised in Masimo's most recent round of financing to $18.2 million. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has developed a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of motion artifact. BT Alex. Brown acted as placement agent for Masimo.

"We started this process planning on raising no more than $10 million, but expanded the size of the offering due to the interest shown by several key investors and Masimo's desire to include them," stated James Scopa, Managing Director in BT Alex. Brown's Healthcare Investment Banking Group. "Masimo was able to attract well known healthcare investors because of its strong fundamentals. Masimo has innovative, proprietary technology, a large potential market and a strong management team."

Masimo Corporation Receives FDA Clearance for Performance During Patient Motion with Masimo SET Technology

January 13, 1998 - Masimo Corporation today announced that it has received clearance from the FDA to expand the indications for use for its pulse oximetry system to include conditions of patient motion. Masimo, a privately-held developer of proprietary signal processing and sensor technologies, has developed a novel approach that measures arterial oxygen saturation and pulse rate even in the presence of high levels of interfering signals or motion artifact.

Pulse oximetry, which is the noninvasive measurement of arterial oxygen saturation, has long been plagued by an inability to give accurate readings during patient motion. This has led to the widespread belief by clinicians, which has been confirmed by numerous studies, that the majority of pulse oximeter alarms are false. In addition to decreasing the reliability of this measurement, this weakness has effectively limited the use of this vital parameter to settings where patient motion is less common, such as the operating and recovery rooms.

"This approval is another critical step in our mission to make Masimo SET^® the new standard in pulse oximetry," stated Joe E. Kiani, President and CEO of Masimo Corporation. "Patient motion has always been the achilles heel to pulse oximetry and has prevented expanded use of the parameter in settings where patient motion is prevalent. No other pulse oximeter has ever received such a claim."