FDA Clears Watch_PAT100: Device for the Detection Of Sleep Related Breathing Disorders

Source: Respironics, Inc.
Caesarea, Israel - January 24, 2002

Itamar Medical announced today that the FDA has cleared Watch_PAT100, the first ambulatory device that detects sleep-related breathing disorders based on the changes in an individual's Peripheral Arterial Tone (PAT) Signal. The PAT is a newly identified physiological signal that reflects arterial pulsatile volume changes in the fingertip, which have been shown in clinical trials to be a reliable indicator of sleep-related breathing disorders such as Obstructive Sleep Apnea (OSA).

The Watch_PAT100 is a self-contained device that is worn on the wrist and uses a non-invasive finger probe to measure the PAT Signal. The recorded signals are stored in a removable memory card in the device to be downloaded to a computer for automatic analysis utilizing proprietary algorithms. In addition to the PAT Signal, the Watch_PAT100 records oxygen saturation, actigraphy, and heart rate.

The Watch_PAT100 offers physicians and the millions of undiagnosed sufferers of obstructive sleep apnea an innovative approach to an unattended ambulatory, patient-friendly, diagnostic evaluation of sleep-related breathing disorders. Therefore the Watch_ PAT100 has the potential to expand the number of sleep tests while lowering the payers' cost per patient and offering a more convenient sleep study performed in the patient's home environment, free of multiple test leads that disturb sleep.

"OSA is significantly under-diagnosed and its consequences are a burden on the healthcare system,'' noted David P. White, MD, Associate Professor of Medicine at Harvard University School of Medicine and Director, Sleep Disorders Program at Brigham and Women's Hospital. "The PAT is a sensitive indicator of sympathetic activity induced by acute periods of airflow obstruction, such as associated with OSA.''

"The FDA clearance of Watch_PAT100 -- which is our second FDA clearance, following the approval of the ETT_PAT 2000 for cardiology applications earlier this year -- is a testament to the strength of the clinical value of our technology,'' states Israel Schreiber, President and Chief Executive Officer of Itamar Medical. "The introduction of the Watch_PAT100 in the U.S. market provides an answer to a well established need for an ambulatory, reliable, patient friendly diagnostic tool." Respironics will market the Watch_PAT100 commencing in early 2002.

"Our experience with providing sleep-related technologies clearly shows that the Watch_PAT100 fills an important void in creating a simple, cost- effective approach to the diagnosis of OSA. Furthermore, PAT will make it possible for sleep professionals to non-invasively uncover a wealth of information about sleep disorders and will provide valuable insight into the relationship between sleep and cardiovascular health.'' noted Jim Liken, Respironics President and Chief Executive Officer. "This innovation fits perfectly in our portfolio of products and we are extremely proud of our relationship with Itamar to bring this exciting new technology to medical professionals and patients."

About Obstructive Sleep Apnea

According to the National Institutes of Health, OSA affects over 18 million people in the US; it is associated with irregular heartbeat, high blood pressure, heart attack, stroke, cognitive and behavioral impairment, daytime fatigue and related motor vehicle and work accidents. Clinicians typically use polysomnographic (PSG) measures to evaluate patients with OSA, which requires an overnight stay in a sleep lab, connected to multiple leads that monitor heart, respiratory, muscle and brain functions. Due to the complexity and capital intensity of sleep lab testing, it is not uncommon to encounter waiting periods of three to six months for a sleep lab test.

About Itamar Medical

Itamar Medical Ltd. is pioneering basic research into the autonomic nervous system and its relationship and effect on the cardiorespiratory and vascular systems. This research has resulted in the identification and development of the PAT (peripheral arterial tone) Signal - a new physiologic signal with important implications for cardiology, and sleep medicine, among other medical fields. Itamar holds patents on the use of the PAT Signal for medical purposes and on a growing body of proprietary technologies - hardware, software, signal processing and algorithms - to allow applications of the PAT signal in many areas of clinical medicine. Itamar Medical, established in 1997, has received investment and technical support from global medical technology leader Medtronic Inc. To learn more about the PAT signal and Itamar Medical, visit www.itamar-medical.com.

About Respironics

Respironics provides products and programs to health care providers while helping them to grow and manage their business efficiently. The company's focus is on home care, hospital and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, allergies and sinusitis, infant jaundice and apnea, heart failure and restrictive lung disorders. The company employs more than 2,000 individuals worldwide and has manufacturing facilities in several domestic and international locations.