Somna Therapeutics (Germantown, WI) won FDA clearance for its REZA BAND UES Assist Device, a product developed to fight symptoms of laryngopharyngeal reflux (LPR) without resorting to surgery or drugs. It works by applying pressure to the cricoid cartilage area right below the laryngeal prominence (the Adam’s apple), squeezing the upper esophageal sphincter and preventing the movement of acid up the esophagus. This relieves the larynx, pharynx, and the lungs from being affected by reflux coming from the stomach. Because of how it’s worn, the REZA BAND is most applicable for night time use, adjusted by the user to be comfortable on the neck during sleep.

The device has considerable evidence pointing to its effectiveness, with 86% of patients studied having a reduction in symptoms after two weeks, while 92% of physicians approving of the technology, according to the company.

Patients suffering from LPR present in physician clinics, hospitals, home health care and specialty clinics such as those for sleep and voice disorders. These patients have in common a dysfunctional upper esophageal sphincter (UES). A poorly functioning UES can result in regurgitation of stomach contents into the larynx, pharynx and lungs. This happens most often at night while sleeping supine. Acid reflux into the throat and lungs causes many challenging symptoms that constitute a spectrum of disorders including chronic throat irritation and cough, hoarse voice, difficulty swallowing, postnasal drip, sleep disruption, and pneumonia.

The REZA BAND is a “first-of-its-kind”, non-medication, non-surgical medical device that is externally worn and applies a slight, external pressure to the cricoid cartilage. In doing so, the REZA BAND generates added intraluminal UES pressure to stop reflux from rising above the UES. The REZA BAND is a clinically-proven, safe and effective option for reducing LPR symptoms such as chronic throat irritation and cough, hoarse voice, difficulty swallowing, and postnasal drip, with few mild and short side effects. The REZA BAND may serve as a potential alternative for patients that typically have a poor response to current standards of treatment.

source:Somna Therapeutics