The U.S. Food and Drug administration has given a key approval to Germantown medical device startup Somna Therapeutics LLC.
Somna has been cleared to sell its Reza Band device—which reduces laryngopharyngeal reflux symptoms—over the counter. The Reza Band will no longer require a prescription, and consumers can buy it directly off the company’s website for $169.
Laryngopharyngeal reflux disease, which Somna says afflicts millions, results in the regurgitation of stomach contents from the esophagus into the larynx, pharynx and lungs. It can cause chronic sore throat, cough, hoarse voice, sleep disruption and other symptoms. The Reza Band is a device worn around the neck to apply light pressure to the cricoid cartilage area to help prevent these symptoms.
Launched in 2012, Somna gradually developed prototypes for its product and finally received FDA approval to offer the Reza Band by prescription in 2015.
Somna now plans to rename the Reza Band to “Reflux Band” to better inform consumers of what it does, and add a smartphone connectivity feature. The device was named after its inventor, Dr. Reza Shaker, chief of Gastroenterology and Hepatology at the Medical College of Wisconsin.
“The Reza Band has helped thousands of reflux sufferers finally find relief from their chronic acid reflux symptoms,” said Laura Jackson, vice president of sales and marketing at 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.”