FDA Approves Nyxoah's Genio® System for Obstructive Sleep Apnea

Nyxoah SA has received FDA approval to market its Genio® system in the U.S. for treating Obstructive Sleep Apnea (OSA) in patients with an Apnea-Hypopnea Index between 15 and 65. This innovative system employs bilateral hypoglossal nerve stimulation, providing a leadless, non-implanted and MRI-compatible solution. The approval follows Nyxoah’s pivotal DREAM trial, which demonstrated significant efficacy, including an AHI responder rate of 63.5% and notable improvements across various sleeping positions.

The company is launching its U.S. commercialization strategy to provide this advanced therapy. With demonstrated safety and efficacy, the Genio system is a significant addition to available OSA treatments, potentially impacting the management of this widespread sleep disorder.