Nyxoah SA’s shares jumped 11.9% on Thursday after the company reported that its Genio system met primary endpoints in the ACCCESS U.S. pivotal study for patients with Complete Concentric Collapse of the soft palate.
The study, which enrolled 47 patients in the primary analysis, achieved a 77.2% Apnea-Hypopnea Index responder rate and a 78.7% Oxygen Desaturation Index responder rate at 12 months. No device-related serious adverse events were reported through the 12-month follow-up period.
Nyxoah closed enrollment ahead of schedule in August 2025, capping participation at 106 patients. The company plans to present the full 12-month dataset at the International Surgical Sleep Society annual meeting in Los Angeles on October 15-16, 2026.
The trial evaluated patients currently contraindicated for commercially available unilateral hypoglossal nerve stimulation in the U.S. Nyxoah is preparing a premarket approval supplement submission to the FDA to expand the Genio indication to this patient population under the FDA’s Breakthrough Device Designation.
The study’s success follows Nyxoah’s shares surging 11.9% on the news, reflecting investor optimism about the potential for regulatory approval and expanded market access for the Genio system.
