For Immediate Release

FDA Approves First Portable Non-EEG Device to Monitor REM Stage Sleep

March 3, 2005

BOSTON, MA and CAESAREA ISRAEL - The Food and Drug Administration (FDA) has now approved a new diagnostic technology which can increase our capacity to diagnosis sleep disorders which affect over 40 million Americans, and have devastating clinical, economic and social consequences, including increased risk of cardiovascular events and motor vehicle accidents, increased use of health services and decreased workplace productivity.

The Watch-PAT, a wrist worn device for ambulatory unattended sleep studies, has now been given FDA clearance for marketing as a diagnostic aid for the detection and rapid eye movement (REM) sleep stages, increasing its accuracy to analyze sleep and diagnose sleep disorders.

REM detection is a critical component of the evaluation of sleep disorders, and has to-date been difficult to measure without the cumbersome use of electroecephalogram (EEG) and electrooculogram (EOG) electrodes geared to the patient's head. .. This approval enhances the diagnostic capability of the Watch-PAT 100, which has been in wide use since 2003 by sleep physicians, general practitioners, pulmonologists and ENT doctors in the US and Europe for analysis of sleep related breathing disorders.

“REM sleep detection is important for proper sleep disorder diagnosis and a critical factor in the evaluation of sleep quality and patient responses to the treatment of sleep apnea,” noted David P. White, MD, Professor of Sleep Medicine at Harvard University School of Medicine and Director, Sleep Disorders Program at Brigham and Women's Hospital. “REM sleep is likely essential to many of the benefits of sleep. Many patients may have disrupted or reduced REM sleep as a product of their sleep disorder, and REM identification can be important in successful diagnosis.”

Before this FDA approval, the only way to detect REM-sleep stages was with an in-lab overnight polysomnographic (PSG) study, which monitors multiple physiological channels including electroencephalogram (EEG), electromyogram (EMG) and electroculogram (EOG). Clinical studies showed that the non-invasive ambulatory Watch-PAT 100 with automated scoring was found to be predictive of REM-sleep very closely to the gold standard in-sleep lab evaluation. Now physicians and patients have a lower-cost option that can expand the availability of diagnostic testing at home or in the hospital or sleep lab.

“The ability to get PSG-quality sleep analysis from a home-based study is an important goal if we are to reach the millions of undiagnosed patients” added Dr. White. “This approval is a critical step towards the adoption and integration of new technologies into practice.

The Watch PAT was developed by researchers at the Technion Israel Institute of Technology and studied at sleep centers affiliated with Harvard Medical School, the Mayo Clinic and Stan. The capability of REM sleep detection allows the Watch-PAT to be considered for use beyond the diagnosis of sleep apnea to other clinical areas such as psychiatry, the differential diagnosis of erectile dysfunction origin psychogenic vs organic), neuro-muscular disorders such as ALS and as a useful tool for clinical trials in the pharmaceutical industry for the evaluation of newly developed drugs that affect sleep architecture.

“The approval of the Watch-PAT 100 for REM diagnosis demonstrates the extraordinary contribution and value of the PAT TM signal in medicine,” added Israel Schreiber, President and CEO of Itamar. “PAT-based products offer lower costs and better outcomes associated with sleep disorders through at-home testing and better monitoring of response to treatment.”

About Itamar

Itamar Medical Ltd. is pioneering the introduction to medicine of a non-invasive window to the autonomic nervous system and arterial health - the PAT™ neuro-vascular signal. The company's researchers are developing proprietary technologies, including non-invasive finger probes and unique algorithms based on advanced signal processing and innovative physiological interpretations, to apply the PAT TM technology in important clinical applications. Itamar's PAT TM -based products can provide early stage detection of disease, facilitate patient follow-up and improve care while reducing costs associated with current tests. Itamar Medical was established in 1997, is headquartered in Caesarea,Israel and has an office in Boston MA.

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