Itamar Medical’s WatchPAT™300 Home Sleep Apnea Testing Device Receives Approval in Japan
CAESAREA, Israel, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Itamar Medical Ltd. (NASDAQ and TASE: ITMR), a leading medical device and digital health company focused on the diagnosis of sleep apnea and other respiratory sleep disorders, announced that its flagship WatchPAT™300 Home Sleep Apnea Testing (HSAT) device has been granted PMDA approval for use in the Japanese market, effective September 14, 2020.
Japan represents the second largest potential patient market for Itamar Medical behind the U.S, where the company currently operates. The WatchPAT™300, an easy-to-use, non-invasive HSAT device, will be made available in Japan through Philips Japan Co., Itamar Medical’s exclusive Japanese distributor since 2014.
Itamar medical is the manufacturer of advanced, FDA cleared, and clinically-validated HSAT devices centered around the unique Peripheral Arterial Tonometry (PAT®) technology used in diagnosing several forms of sleep apnea. This technology can also be used in the diagnosis of sleep apnea in patients with cardiovascular comorbidities in which it poses a significant and independent risk factor. Sleep apnea affects approximately one billion people worldwide and Itamar Medical is passionate about providing an easy access solution to address the roughly 80% patient population that remain undiagnosed and untreated.
About WatchPAT™
WatchPAT™, the FDA-approved flagship product developed by Itamar Medical, is used for diagnosing Sleep Apnea at patients home. The WatchPAT is an easy-to-use Watch-like device alternative to traditional in-lab polysomnography tests with unique abilities to score test results automatically, as well as produce a full sleep apnea diagnosis report. It provides a variety of respiratory indices, distinguishes between sleep and wakefulness, and provides a complete context of sleep architecture that includes the analysis of apnea events in each of the 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 FDA-cleared Central PLUS Module also enables specific identification of Central Sleep Apnea (CSA) events.
About Itamar Medical Ltd.
Itamar Medical is a medical technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of respiratory sleep disorders. Itamar Medical commercializes a digital healthcare platform to facilitate the continuum of care for effective sleep apnea management with a focus on the core sleep, cardiology and direct to consumer markets. Itamar Medical offers a Total Sleep Solution to help physicians provide comprehensive sleep apnea management in a variety of clinical environments to optimize patient care and reduce healthcare system costs. The Company’s key product, WatchPAT, is commercially available within major markets including the US, Japan, and Europe. Itamar Medical is a public company traded on the Nasdaq and on the Tel Aviv Stock Exchanges, and is based in Caesarea, Israel with U.S. headquarters based in Atlanta, GA. For additional information visit www.itamar-medical.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Statements preceded by, followed by, or that otherwise include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", and similar expressions or future or conditional verbs such as "will", "should", "would", "may" and "could" are generally forward-looking in nature and not historical facts. For example, when we discuss making WatchPAT 300 available in Japan, we are using forward-looking statements. Because such statements deal with future events, they are subject to various risks, uncertainties and assumptions, including events and circumstances out of Itamar Medical's control and actual results, expressed or implied by such forward-looking statements, could differ materially from Itamar Medical's current expectations. Factors that could cause or contribute to such differences include, but are not limited to, risks, uncertainties and assumptions discussed from time to time by us in reports filed with, or furnished to, the U.S. Securities and Exchange Commission (“SEC”) and the Israel Securities Authority (“ISA”), including our latest Annual Report on Form 20-F which is on file with the SEC and the ISA. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Itamar Medical Company Contact
Itamar Medical Ltd.
Shy Basson
Chief Financial Officer
Phone: +972-4-617-7700
bshy@itamar-medical.com
Itamar Medical Investor Relations Contact (U.S.)
Leigh Salvo or Caroline Paul
Gilmartin Group
Phone: +1-415-937-5412
investors@itamar-medical.com
