GERMANTOWN, Wis.--(BUSINESS WIRE)--Somna Therapeutics LLC today announced that the U.S. Food and Drug Administration (FDA) has cleared the Reza Band as the first over-the-counter device of its kind for the reduction or elimination of laryngopharyngeal reflux (LPR) symptoms. The Reza Band is a groundbreaking, non-medication and non-surgical device that is worn on the neck. It stops regurgitated stomach contents from passing above the upper esophageal sphincter (UES) and into the throat and lungs which can cause chronic coughing, wheezing, difficulty swallowing and a host of other head and neck symptoms.
The Reza Band previously received 510(k) clearance from the FDA and has been available by prescription since 2015.
“The Reza Band has helped thousands of reflux sufferers finally find relief from their chronic acid reflux symptoms,” said Laura Jackson, vice president, sales and marketing, Somna Therapeutics. “The Reza Band has proven to be safe and highly effective, and we’re proud to offer it without the need for a prescription to the millions who suffer from this condition.”
The Reza Band soon will be renamed Reflux Band to better convey the product’s benefits to the direct-to-consumer market. Somna Therapeutics also plans to release an additional Reflux Band product option with smartphone connectivity for an enhanced user experience.
In the coming months, Somna Therapeutics will launch a nationwide advertising campaign to educate consumers about the Reflux Band as a safe and effective treatment alternative to medication, surgery and sleep modification. Somna Therapeutics anticipates rapid growth as the millions who suffer from this condition are introduced to the first non-pill, non-invasive treatment for acid reflux.
About the Reza Band
The clinically-proven Reza Band provides relief from LPR symptoms by applying slight external pressure to the cricoid cartilage area located below the Adam’s apple, which increases the internal pressure of the UES. The device reduces challenging symptoms such as chronic throat irritation and cough, hoarse voice, difficulty swallowing, and postnasal drip. The Reza Band was founded on scientific and clinical research conducted over 20 years by a leading gastroenterologist at the Medical College of Wisconsin.
About Laryngopharyngeal Reflux (LPR) Disease
Millions of people suffer from laryngopharyngeal reflux (LPR) disease. Those who suffer from this disease have a dysfunctional upper esophageal sphincter (UES). A poorly functioning UES results in regurgitation of stomach contents from the esophagus up and into the larynx, pharynx and lungs. This can cause health issues such as chronic throat irritation, cough, hoarse voice, asthma, difficulty swallowing, postnasal drip, pneumonia and sleep disruption. Alternate treatments include lifestyle modification, drug therapy and surgery.