Evidence-based guidelines based on a large-scale sleep apnea study demonstrating
WatchPAT’s efficiency and accuracy compared to standard diagnostic alternatives

CAESAREA, Israel, May 30, 2018 (GLOBE NEWSWIRE) -- Itamar Medical Ltd. (TASE:ITMR), a company that develops, manufactures, and markets non-invasive diagnostic medical devices for cardiology and sleep related breathing disorders, today announced plans to unveil the WatchPAT Scoring Guidelines, a streamlined approach for reviewing and editing WatchPAT data that integrates automated scoring with visual oversight. Researchers at Johns Hopkins Sleep Disorder Center developed the evidence-based guidelines, which will be presented June 5, 2018 at a lunch symposium hosted by Itamar Medical at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS). The meeting is taking place in Baltimore June 2 – 6. Latest surveys estimate that up to 1 billion patients around the world may be suffering from sleep apnea and over 80% of them are undiagnosed.

Itamar Medical’s WatchPAT is an FDA-approved portable diagnostic device that uniquely uses finger-based physiology and innovative technology to enable simple and accurate Sleep Apnea (SA) testing while avoiding the complexity and discomfort associated with traditional airflow-based systems. As a device for Home Sleep Apnea Testing (HSAT) based on Peripheral Arterial Tone (PAT^TM) signal, WatchPAT has revolutionized the approach to sleep apnea testing since it was introduced over a decade ago as an easy to use, yet comprehensive alternative to traditional diagnostic methods. A growing body of evidence suggests that sleep apnea contributes to the development and progression of highly prevalent co-morbidities including atrial fibrillation, cardiovascular disease, diabetes and congestive heart failure.

While Clinical Practice Guidelines published in early 2017 officially recognized PAT-based technologies as technically adequate for HSAT, the AASM and most third-party payers require the HSATs raw data be available for review by a sleep expert and manual editable as needed. This requirement resonates with traditional roles of sleep professionals, who are trained to score, review, edit and report results from all sleep studies. Recent AASM updates on Sleep Apnea Test Scoring Guidelines reflects this approach, which facilitates systematic approaches to scoring and reviewing. WatchPAT technology, however, is unique among HSAT devices in its ability to render a fully automated, validated report, which was proven to have high correlation with gold standard polysomnography. Despite the potential benefits that full automation may offer, methods for implementing guidelines for scoring and review of WatchPAT recordings have not previously been available. Researchers at the Johns Hopkins Sleep Center have now addressed this challenge with the development of WatchPAT Scoring Guidelines.

“We found WatchPAT to be a cost-effective, easy to use and reliable HSAT method,” said Alan Schwartz, Professor of Medicine and the Director of the Sleep Disorder Center at Johns Hopkins and an author on the guidelines. “Its accuracy in diagnosing sleep apnea is enhanced by its ability to estimate actual sleep time rather than total recording time. Our goal in developing Scoring Guidelines for WatchPAT was to leverage its technologic advantages with methods that maintain its accuracy and diagnostic efficiency.”

The WatchPAT Scoring Guidelines were developed from a large patient sample in the COMPASS study at Johns Hopkins Sleep Center. The cohort included patients with co-morbidities such as atrial fibrillation, morbid obesity and heart failure.  The Guidelines outline the physiologic background for the scoring approach, provide methodology for verifying, reviewing and editing WatchPAT recordings with simple, step-by-step procedures for sleep clinicians and technologists.

“As a company dedicated to realizing the broad potential of PAT technology to improve the quality of healthcare, we recognize the importance of developing innovative solutions to real world clinical needs,” said Gilad Glick, CEO of Itamar Medical. “The new WatchPAT Scoring Guidelines should facilitate the use of this powerful HSAT device, enabling the identification and treatment of OSA in a broad population while potentially significantly reducing cost to the healthcare system. We are grateful to the team at Johns Hopkins Sleep Center for their efforts and their rigorous approach and commitment to developing practical tools for helping underserved patient populations.”

Atul Malhotra, MD, Division Chief, Pulmonary, Critical Care and Sleep Medicine and Director of Sleep Medicine at UC San Diego School of Medicine and David Rapoport, MD, Director, Sleep Medicine Research Program at Icahn School of Medicine will co-chair the lunch symposium, which will be held June 5, 2018 12:30 p.m. EDT – 1:30 p.m. EDT in Room 308 of the Baltimore Convention Center. Additional symposium speakers and topics are:

• The PAT® Validation Literature; Richard Berry, MD, Medical Director, University of Florida Health Sleep Disorders Centers, Gainsville, FL
• The JHS Study and Outcomes; Alan Schwartz, MD, Director, Sleep Disorders Center, Johns Hopkins Bayview Medical Center
• The JHS Scoring Guidelines; Hartmut Schneider, MD, PhD, Laboratory Director of the Johns Hopkins Bayview Sleep Disorders Center

A Q&A session and panel discussion with the speakers will take place following the presentations.

About Itamar Medical Ltd.
Itamar Medical is engaged in research, development, sales and marketing of non-invasive medical devices for the diagnosis of respiratory disorders with focus on the cardiology market. The Company's flagship products, which are based on its unique technology, are WatchPAT™, a home-use diagnostic device for sleep breathing disorders, and EndoPAT™, an FDA-approved device to test endothelial dysfunction and to evaluate the risk of heart disease and other cardiovascular diseases. Itamar Medical is a public company traded on the Tel Aviv Stock Exchange and is based in Caesarea, Israel.

For further details: Erich Sandoval, Lazar Partners Ltd. 917-497-2867

¹ Comparison of Monitoring with WatchPAT vs. Sleep Studies