Highlights: • In October 2010, the American Medical Association to announce a new CPT (Current Procedural Terminology) code for at-home testing of obstructive sleep apnea (OSA), which will go into effect January 1, 2011. • Home testing and diagnosing of OSA will now become uniformly reimbursable for all physicians. • Home testing with the WatchPAT (wrist-worn device and finger-mounted probe) delivers diagnostic accuracy at a fraction of the cost of sleep lab testing, significantly lowering the cost of health care. • Several key studies indicate that patients with undiagnosed and untreated OSA utilize health care resources almost two-fold higher—with heavier use of resources seen in women. • Outpatient testing for sleep-related breathing disorders using a wrist-worn device and finger-mounted probe was selected as one of the Top 10 Medical Innovations for 2010 by a panel of experts at the world-renowned Cleveland Clinic.

Newswise — It is estimated that over 28 million Americans suffer from obstructive sleep apnea (OSA), with approximately 20 million more going undiagnosed and untreated. The health-related cost burden for undiagnosed OSA in the United States—a dangerous condition that can lead to a variety of heart ailments, stroke, and death—is estimated at $3.4 billion. The latest figures compiled by Frost & Sullivan in 2008 show revenues in the U.S. sleep apnea diagnostic and therapeutic market totaling approximately $1.35 billion, with a 16.2% growth rate.

WatchPAT, produced by medical device manufacturer Itamar-Medical, Ltd., is the industry leader for at-home OSA testing. WatchPAT is approved, available for all physicians as a diagnostic tool, and is poised to continue market domination once the CPT (Current Procedural Terminology) code for at-home diagnosis goes into effect January 1, 2011.

“With the new CPT code going into effect, millions of Americans suffering from sleep apnea can now benefit from easy, low cost access to in-home sleep testing using our WatchPAT device,” notes Dr. Dov Rubin, President and CEO of Itamar-Medical. “Patients can now take the test in the comfort of their own bed, affording them timely diagnosis and treatment for sleep apnea, which is linked to other ailments such as heart disease, hypertension, and obesity.”

Rubin also adds, “Internists, cardiologists, and family physicians can now order the tests and get reimbursed. Using Itamar-Medical’s WatchPORTAL technology, physicians can download the information instantaneously at no extra charge and obtain a diagnosis in consultation with a local sleep physician or via Itamar’s nationwide network of experts, with results wirelessly delivered back to a smartphone.”

WatchPAT sleep tests outnumber the nearest competitor by 5:1, making it by far the most used at-home sleep apnea testing device of its kind. While sleep lab PSG (polysomnography) testing has been the standard of care for OSA diagnosis, it is anticipated that many labs will also be offering home testing in order to expand their services. In a July 2010 Wells Fargo Securities survey of national sleep centers, analysts reported that 21% of sleep centers currently offer home sleep testing for Medicare patients and 23% offer home testing for privately insured patients, both up from 20% from a previous survey.

Additionally, another 29% of sleep centers plan to offer home tests in the next six months, up from 19% since their previous survey. Moreover, 38% of the respondents indicated that they plan to increase involvement in home testing, up from 32% from the prior survey.

According to Dr. Steven Lamm, a New York internist who regularly performs WatchPAT tests on his patients, “With WatchPAT and the new CPT code, we now have the technology that will allow community doctors nationwide easy access to diagnosing sleep apnea. Because of that, the role of the sleep lab will change. Sleep lab testing is still extremely important, though I want to reserve it for those patients with especially complicated sleep issues, such as restless legs syndrome, insomnia, and narcolepsy.”

About WatchPAT™: With over 250,000 tests worldwide, WatchPAT is the most convenient, portable sleep testing device on the market. Easily worn by patients in the comfort of their own homes, this is the only portable device providing Apnea-Hypopnea Index (AHI), Respiratory Disturbance Index (RDI), and Oxygen Desaturation Index (ODI) based on actual sleep time and sleep states (REM/Wake/Deep/Light)—all without a cumbersome nasal cannula or belt around the chest. This gives the patient greater comfort, more natural sleep, as well as an amazingly low failure rate. Sleep physicians use Itamar’s intuitive software to review the data channels and manually override the automatic suggested scoring (the actual sleep data cannot be changed). WatchPAT’s newest features include multi-night capability, tamper-proof chain of custody for occupational testing, and seamless, web-enabled study upload to Electronic Medical Records and downloads to smartphones.

About OSA: OSA is the fragmented, disturbed sleep, causing a person’s breathing to be interrupted hundreds of times a night, resulting in dramatic changes within the body. Consequently, it creates an unhealthy and dangerous domino effect: • Oxygen levels fluctuate and enormous strain is put on the heart • It leads to hypertension, weight gain, obesity, diabetes, and heart disease • Risk for heart attack, stroke, and death increases significantly • When sleep is disrupted daily, fatigue sets in and becomes a chronic condition • Rates of driving and workplace accidents increase significantly • People eat more and become less physically active; sexual relations are affected

Heart disease is by far the biggest killer in the United States. According to the American Heart Association, cardiovascular disease and stroke annually cost the healthcare system approximately $475.3 billion. A significant number of patients with hypertension and other cardiovascular diseases have some form of sleep related breathing disorder, with OSA being the most significant. At the conclusion of an 18-year study supported by the National Heart, Lung, and Blood Institute, it was reported in 2008 that adults ages 30 to 60 with sleep-related breathing disorders, OSA included, were two to three times more likely to die than those who did not have a sleep-related breathing disorder.

About Itamar-Medical: Itamar-Medical Ltd., established in 1997, is a publicly traded medical device company (TASE:ITMR), which developed the proprietary PAT™ (Peripheral Arterial Tone) signal. The PAT signal is a non-invasive “window” to the cardiovascular system and the autonomic nervous system. Today, it is used clinically for detection of obstructive sleep apnea, early detection of heart disease, and erectile dysfunction. PAT-based products provide early-stage detection of disease and facilitate follow-up, improving patient care while reducing the overall cost of health care. The company’s U.S. headquarters are in Franklin, MA. Related Links:http://www.itamar-medical.com/WatchPAT.htmlRelevant WatchPAT clinical studies:http://www.itamar-medical.com/WatchPAT/Medical_Professional/WatchPAT_/WatchPAT_Clinical_Studies.html

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