The FDA has granted marketing clearance to the Reza Band UES Assist device for treating the symptoms of laryngopharyngeal reflux, the manufacturer announced.
The Reza Band (Somna Therapeutics) is designed to reduce laryngopharyngeal reflux symptoms (chronic throat irritation, cough, hoarse voice, difficulty swallowing and postnasal drip) by stopping regurgitation of stomach contents through the upper esophageal sphincter, according to a press release. It is a novel, non-medication, nonsurgical device designed to be worn externally, and relieves symptoms by applying slight pressure to the cricoid cartilage area below the Adam’s apple to increase internal pressure of the upper esophageal sphincter.
“The FDA clearance of the Reza Band is a significant milestone for Somna Therapeutics and for those suffering from acid reflux into the throat and lungs,” Nick Maris, president and CEO of Somna Therapeutics, said in a press release. “The first-of-its-kind Reza Band provides significant improvement in symptoms that are typical when stomach contents enter the throat and lungs.”
The approval follows data from a multicenter clinical study in which 86% of patients had significant reduction in symptoms after 2 weeks of using the Reza Band. Physicians were satisfied with the device 92% of the time and 75% of patients were satisfied or very satisfied, according to the release.