Sommetrics Receives IDE Approval From the FDA to Begin SUPRA Trial of aerSleep II for Treating Sleep Apnea

The SUPRA clinical trial’s principal investigator, Dr. Kingman Strohl (Program Director in Sleep Medicine, University Hospitals Cleveland Medical Center, and Professor of Medicine, Case Western Reserve University, Cleveland OH) stated, “OSA is a major public health concern which detrimentally affects the quality of life for up to 20% of Americans. Sommetrics’ aerSleep system offers a first-in-class, comfortable, silent and non-invasive option for treating OSA sufferers. Although CPAP therapy is very effective, it is typically only used for about half of a subject’s sleep time and only about half of patients who are prescribed PAP therapy tolerate long term use of the treatment. There is an urgent need for alternative treatment options.”

aerSleep II uses a soft silicone collar to apply mild negative pressure over the external surface of the neck to hold the airway open during sleep. It is a small self-contained unit with an integrated vacuum pump which is quiet and easy to use and maintain. The unit is portable and held in place without the need for a retaining strap. It allows users to easily talk and swallow without anything on their face or in their mouth. Also, it does not spread infectious aerosols from the user’s airway like CPAP. In previous clinical studies, there was a strong subject preference for aerSleep over previously used therapies like CPAP and oral devices.

About Sommetrics

Sommetrics is a privately funded company located in San Diego County, California. It is focused on improving sleep quality by providing products and services that deal with disorders of the upper airway such as obstructive sleep apnea (OSA) and snoring. For more information, visit www.sommetrics.com.

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