Sommetrics, a private company developing products and services to improve sleep health, has announced its lead sleep apnea product, aerSleep II, has received FDA Breakthrough Device designation. This program allows for additional FDA feedback to sponsors during the pre-marketing phase but does not alter the basic requirements for market authorization. The Breakthrough Device program is intended to help patients gain more timely access to products that have the potential to provide more effective therapy than currently available options for medical conditions that are either life-threatening or irreversibly debilitating.
“This designation recognizes the real promise of aerSleep II as a first-in-class therapy for people with sleep apnea who are unable to benefit from current therapies,” remarked Dr. Kingman Strohl, Program Director, Sleep Medicine, University Hospital, Cleveland, and Professor of Medicine, Case School of Medicine. “aerSleep II is simple to use and comfortable, with new design features which can translate into effectiveness and better compliance with treatment. Also, unlike some other alternatives to standard CPAP therapy, aerSleep II has been shown in previous clinical studies to be effective in patients with all degrees of sleep apnea severity.”
aerSleep II applies negative pressure over the neck’s external surface to hold the airway open during sleep. It is a self-contained unit with an integral vacuum pump, which is quiet and easy to use and maintain. The unit is portable and is held in place without the need for a retaining strap. There was a strong preference for aerSleep over other therapies like CPAP and oral devices in previous clinical studies.
Eric Koehler, Sommetrics’ Vice President for Clinical Operations and Regulatory Affairs, commented, “We are pleased to see aerSleep II receive this designation, which allows us to have more streamlined and frequent interactions with FDA in a joint effort to bring this much-needed device to the market as soon as possible. Sleep apnea remains a major public health problem, with more than 20% of adults afflicted and only a small fraction receiving effective therapy. We expect aerSleep II to address this extraordinary unmet need for better tolerated and effective options to treat sleep apnea, a life-threatening disease with important co-morbidities.”