Nyxoah SA, a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. Genio’s unique design utilises bilateral stimulation and offers patients a leadless, full-body 1.5T and 3T MRI-compatible, non-implanted battery solution, powered and controlled by a wearable component. The wearable component is fully upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.

"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. commercialisation strategy.”
        
The Genio system’s FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company's DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints, demonstrating an AHI responder rate of 63.5 per cent and an Oxygen Desaturation Index responder rate of 71.3 per cent, with an overall median AHI reduction of 70.8 per cent. Additionally, 82.0 per cent of all DREAM subjects saw their AHI scores drop below 15 or lower.