Nyxoah reported its ACCCESS U.S. pivotal study met primary safety and efficacy endpoints in complete concentric collapse obstructive sleep apnea patients.
Results showed the Genio implant delivered strong clinical response at 12 months with no device-related serious safety events.
Management is preparing an FDA PMA supplement to expand the U.S. indication for complete concentric collapse patients under Breakthrough Device Designation.
The full 12-month dataset is scheduled for presentation at the ISSS annual meeting in Los Angeles on Oct. 15-16, 2026.
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