Le Lézard
Classified in: Health
Subjects: TRI, FDA

An Important Recognition in the US Market for the WatchPATtm Device: The American Academy of Sleep Medicine ("AASM") has Formally Endorsed Itamar Medical's WatchPATtm Technology to Diagnose Sleep Apnea, Based on Published Evidence


CAESAREA, Israel, March 16, 2017 /PRNewswire/ -- Itamar Medical Ltd. (TASE: ITMR) reports that AASM, the leading medical association of sleep medicine physicians in the United States, has published an updated version of its Clinical Practice Guideline for Diagnosis of Sleep Apnea that includes the company's PAT® Peripheral Arterial Tonometry) technology. The new guideline was published in the March 15 issue of the Journal of Clinical Sleep Medicine, and is the first revision of the guideline since 2007.

The Company believes that the revised guidelines will support ongoing efforts to make home sleep testing standard among doctors, patients and insurance companies in the U.S. and around the world, as well as support commercialization of WatchPATtm, the company's home sleep apnea testing (HSAT) device, in the U.S. market.

Gilad Glick, CEO of Itamar Medical:

"We are pleased that, after a decade of investment in technology development, validation studies and clinical implementation, the core WatchPAT technology has been recognized as equivalent to traditional cardiopulmonary HSAT by the highest U.S. authority ? the AASM." 

The guideline was based on a systematic literature review, meta-analyses, and assessment of evidence, and was developed by an expert task force of board-certified sleep medicine physicians. It represents yet another important milestone in the adoption of home sleep testing in the United States. The Company estimates that this will have a positive impact on the decisions of the few insurance companies in the U.S. who have yet to include WatchPAT in their coverage policies.

Itamar Medical's PAT® technology is based on a physiological signal acquired non-invasively from the finger and is one of only two AASM-recognized technologies, alongside the Air-Flow based systems. In the market for home sleep testing devices, PAT technology is recognized as easy-to-use and highly accurate. AASM's guidelines are based on published scientific evidence that references both the quality and quantity of evidence and patient preferences.

Mr. Glick, further stated today that, "The AASM's recognition of the PAT technology is an important milestone in the implementation of our quest to grow in the U.S. market. The WatchPAT is sold today both as a stand-alone device and, more importantly, as part of a comprehensive solution to further aid the diagnosis and treatment for sleep apnea patients that suffer from related comorbidities, such as cardiac diseases."  

About WatchPATtm 

WatchPAT, the FDA-approved flagship product developed by Itamar Medical, is used for diagnosing Sleep Apnea in the home environment. The WatchPAT is an easy-to-use patient-led alternative with unique abilities to interpret test results automatically, as well as produce a full sleep report. It provides a variety of respiratory indices, distinguishes between sleep and wakefulness, and provides a complete sleep architecture that includes the analysis of sleep stages such as light sleep, deep sleep and REM sleep. The WatchPAT also records snoring volume and body position information throughout the night. The recently FDA cleared Central PLUS Module, also enables specific identification of Central Sleep Apnea (CSA).

About Itamar Medical Ltd.

Itamar Medical Ltd. is a publicly traded medical device company (TASE:ITMR) that develops and markets innovative diagnostic and therapy solutions for sleep breathing disorders and cardiovascular conditions.

Over the last two years, Itamar Medical has signed a number of strategic marketing agreements for WatchPAT, including agreements with Medtronic in the U.S., and Philips Respironics GK in Japan.

Contact:
Gilad Glick
Chief Executive Officer and President
T: +972-4-6177000 
[email protected]

 

SOURCE Itamar Medical Ltd


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