On Aug. 8, 2025, Nyxoah announced that the FDA approved the Genio system for a subset of patients with moderate to severe obstructive sleep apnea (OSA) who have an apnea-hypopnea index (AHI) between 15 and 65.
About Genio
Genio is a hypoglossal nerve stimulator that delivers bilateral stimulation and is designed with a battery-free, leadless implant. It is compatible with both 1.5T and 3T MRI scans and is powered and controlled externally through a wearable device worn during sleep. The system can be inserted through a single incision in a one-time procedure.
The wearable component connects to a smartphone app, which provides comfort settings, allows patients to track their sleep progress, and enables adjustment of stimulation levels.
Genio therapy offers an alternative for patients who have failed, refused or cannot tolerate positive airway pressure therapies such as CPAP and who meet additional eligibility criteria.
Clinical data
FDA approval was supported by safety and efficacy results from the company’s DREAM trial. The study met its primary and secondary endpoints, demonstrating a 63.5% AHI responder rate and a 71.3% oxygen desaturation index responder rate. Participants experienced a median AHI reduction of 70.8%, and 82% achieved an AHI below 15. The results showed Genio was effective regardless of sleeping position.
About obstructive sleep apnea
OSA is a serious sleep disorder in which the airway repeatedly becomes blocked during sleep, causing pauses in breathing. It is often marked by loud snoring and choking sounds and can lead to oxygen deprivation, sleep disruption, and increased risk of high blood pressure, heart disease, stroke and diabetes.
Related: FDA grants breakthrough device designation to Genio system for OSA (Sept. 14, 2021)
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