Nyxoah says ACCCESS pivotal trial meets 12-month safety, efficacy endpoints in CCC sleep apnea patients

• 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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nyxoah SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609021605PRIMZONEFULLFEED1001260718) on September 02, 2026, and is solely responsible for the information contained therein.