CAESAREA, Israel, Sept. 21, 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, is pleased to report that The German Sleep Society (DGSM) has released an update to its clinical guidelines for Sleep-Related Breathing Disorders (SRBD) recognizing Peripheral Arterial Tonometry (PAT™) technology as an equivalent alternative to polygraphy-based Home Sleep Apnea Testing (HSAT) systems. The new guidelines were published in Somnologie Magazine on September 9th, 2020.
These guidelines set the specifications for accepted technologies and practices to be used in the diagnosis and treatment of SRBD, marking another major achievement in the recognition and adoption of PAT™ technology and PAT-based HSAT systems in Europe. Accreditation by the foremost medical society clinical guidelines, in any market, serves as a fundamental first step in the pathway towards full reimbursement. As such, these updated guidelines may assist in paving the way for the reimbursement of the company’s WatchPAT™ devices in Germany.
“We are very pleased to see the recognition of PAT™ technology by the German Sleep Society,” said Eilon Livne, Vice President of Sales and Channels Development EMEA at Itamar Medical. “This is an important landmark as we are committed to removing obstacles in sleep medicine markets worldwide and specifically expanding our reach within the European market. We are excited to begin delivering a comprehensive solution to aid the diagnosis and treatment of sleep apnea patients in Germany and continue filling the substantial gap in the current clinical pathway which leaves the vast majority of Sleep Apnea patients undiagnosed.”
Sleep apnea, which affects approximately 1 Billion people worldwide, is a sleep disorder in which breathing repeatedly stops and starts, and is also often associated with other serious health problems, especially cardiovascular disease. Itamar Medical’s PAT™ technology, based on a physiological signal acquired non-invasively from the finger, allows for the simple and accurate diagnosis of this disorder, supporting the company’s efforts to provide an easy access solution to address the estimated 80% undiagnosed Sleep Apnea patient population.
To date, PAT™ is the only alternative technology to airflow-based systems, that is accredited and endorsed by U.S, Dutch, UK, and Swedish sleep-related clinical guidelines.
“The PAT™ technology provides sleep physicians with unprecedented access to information regarding sleep and sleep disturbance in comparison to standard outpatient recording,” said Prof. Dr. med. Boris A. Stuck, Professor and chair of the Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Germany. “In this context, sleep duration, sleep architecture and sympathetic arousals are of particular interest. Moreover, the technology is easy to handle for both physician and patient.”
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 FDA-cleared Central PLUS Module also enables specific identification of Central Sleep Apnea (CSA).
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.
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 obtaining reimbursement for our products, 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.
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SOURCE: https://www.w24news.com
