Nyxoah Study Supports Expanded Indication for Sleep Apnea Treatment in US

01:11 AM EDT, 09/03/2026 (MT Newswires) -- Nyxoah (NYXH.BR) said Wednesday its Acccess US pivotal study met its primary safety and efficacy endpoints in patients with complete concentric collapse, or CCC, of the soft palate. The study was designed to support an expansion of the US indication for Genio, Nyxoah's obstructive sleep apnea treatment system, to include CCC patients. Enrollment was completed ahead of the planned maximum of 106 patients. At 12 months, patients achieved an apnea-hypopnea index responder rate of 77.2% and an oxygen desaturation index responder rate of 87.7%. The primary analysis included 47 patients who were implanted, activated, and completed at least one in-study sleep test. The obstructive sleep apnea-focused medical technology company plans to submit a premarket approval supplement to the US Food and Drug Administration seeking to expand Genio's indication to CCC patients.