Nyxoah wins FDA nod for sleep apnea neuromod system

Nyxoah (Nasdaq:NYXH) announced today that it received FDA approval for its Genio neuromodulation device for treating sleep apnea.

Genio utilizes an implanted electrode around the hypoglossal nerve, stimulating the tongue and keeping the airway open. The unique design utilizes 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. This fully upgradeable wearable component provides access to the technology without requiring additional surgeries for technology updates or battery replacements.

Mont-Saint-Guibert, Belgium-based Nyxoah received approval for a subset of patients with moderate to severe obstructive sleep apnea (OSA). These patients have an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

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