Nyxoah SA’s shares advanced 11.9% on Thursday after the company reported positive results from its U.S. pivotal study of the Genio system for obstructive sleep apnea treatment.
The ACCESS U.S. Pivotal Study evaluated the Genio system in patients with Complete Concentric Collapse of the soft palate, a group currently contraindicated for available unilateral hypoglossal nerve stimulation devices in the United States. The trial met its primary safety and efficacy endpoints, with a Full Analysis Set of 47 patients who were implanted, activated, and completed at least one in-study sleep test.
Efficacy results showed a 77.2% responder rate on the Apnea-Hypopnea Index and a 78.7% responder rate on the Oxygen Desaturation Index. The study reported zero device-related serious adverse events through 12 months and met the Sher criteria at 12 months. Enrollment was closed ahead of schedule in August 2025, with 47 patients enrolled instead of the planned 106.
Nyxoah plans to submit a premarket approval supplement to the U.S. Food and Drug Administration to expand the Genio indication to Complete Concentric Collapse patients under the FDA’s Breakthrough Device designation. The complete 12-month dataset is scheduled for presentation at the International Surgical Sleep Society annual meeting in Los Angeles on October 15–16, 2026.
