Somna Therapeutics today announced that the U.S. Food and Drug Administration (FDA) cleared the REZA BAND® UES Assist Device for marketing in the U.S. The REZA BAND is a ground-breaking, new, externally-worn, non-medication, non-surgical medical device designed to reduce symptoms of laryngopharyngeal reflux (LPR) by stopping regurgitation of stomach contents through the upper esophageal sphincter (UES).
"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," said Nick Maris, President and CEO of Somna Therapeutics. "The first-of-its-kind REZA BAND provides significant improvement in symptoms that are typical when stomach contents enter the throat and lungs."
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 with few mild and short side effects. The REZA BAND is founded on scientific and clinical research conducted over twenty years by a leading gastroenterologist at the Medical College of Wisconsin.
The FDA evaluated the REZA BAND based on data from a multi-center clinical study designed to assess safety and effectiveness when worn by patients who had been clinically diagnosed with LPR. Eighty-six percent (86%) of patients had a successful outcome using the REZA BAND with a significant reduction in symptoms after just two weeks. See the Instructions for Use for full prescribing, safety and effectiveness information at www.rezaband.com/instructions. Physicians reported being satisfied with the device 92% of the time and 75% of patients reported being satisfied or very satisfied.
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