GERMANTOWN, Wis., Nov.20, 2013 – Somna Therapeutics today announced that it has filed a de novo petition with the FDA seeking 510(k) marketing clearance for a new externally-worn, non-invasive medical device designed to treat symptoms of acid reflux into the throat and lungs.
The Reza Band™ UES Assist Device applies slight pressure to the upper esophageal sphincter to prevent stomach acid from traveling into the throat and lungs and is mainly worn during sleep. The Reza Band is founded on scientific and clinical research conducted over twenty years by a leading gastroenterologist at the Medical College of Wisconsin.
"Our recently completed and successful, multi-center clinical trial serves as the backbone of our submission to the FDA. This trial demonstrated the Reza Band provided significant improvement in symptoms that are typically the result of the reflux of stomach contents into the throat and subsequent aspiration into the lungs," stated Nick Maris, President and CEO of Somna Therapeutics. "The study also showed excellent patient compliance and physician satisfaction."
About Acid Reflux Disease
Millions of people suffer from acid reflux into the throat and lungs. This most often occurs at night, while sleeping. Patients suffering from the disease have a dysfunctional upper esophageal sphincter (UES). A poorly functioning UES can result in regurgitation of stomach contents from the esophagus, through the protective UES, and up into the larynx, pharynx and lungs. Acid reflux into the throat and lungs can cause health issues such as chronic throat irritation and cough, hoarse voice, asthma, difficulty swallowing, postnasal drip, pneumonia and sleep disruption. Current therapies include behavior modification, drug therapy and surgery.
About Somna Therapeutics LLC
Founded in March 2012 in partnership with the Medical College of Wisconsin, Somna Therapeutics is a medical device company focused on improving the quality of life for the millions of people suffering from acid reflux disease by introducing the Reza Band™ UES Assist Device, the first-of-its-kind, non-invasive, non-medication treatment for acid reflux into the throat and lungs. Upon FDA clearance and product launch, the company plans to sell the Reza Band™ UES Assist Device to hospitals, health care systems and physician clinics. Additional information about Somna Therapeutics is available at www.somnatherapeutics.com.
CAUTION: Investigational device. Limited by Federal (USA) law to investigational use.
Help employers find you! Check out all the jobs and post your resume.
