Nyxoah Receives FDA Approval for Genio Sleep Apnea System

Nyxoah SA has received FDA approval for its innovative Genio® system designed to treat moderate to severe obstructive sleep apnea (OSA) in patients with an Apnea-Hypopnea Index (AHI) between 15 and 65. The Genio system distinguishes itself by using bilateral hypoglossal nerve stimulation with a leadless, non-implanted battery solution controlled by an upgradable wearable component, compatible with 1.5T and 3T MRI. This approval follows the successful DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate, a 71.3% Oxygen Desaturation Index responder rate, and a median AHI reduction of 70.8%, including significant improvements in challenging sleeping positions. Nyxoah's CEO Olivier Taelman emphasized the importance of this regulatory milestone and the company's commitment to providing a new, effective treatment option for OSA patients in the U.S. The company has officially launched its U.S. commercialization strategy to bring this therapy to market and simplify treatment for OSA sufferers. The Genio system's novel approach and positive clinical results position it as a promising alternative in the OSA treatment landscape.