Nyxoah’s Genio System Hits Key Safety and Efficacy Marks in U.S.…

Event summary

Nyxoah’s ACCCESS U.S. pivotal study met primary safety and efficacy endpoints in Complete Concentric Collapse (CCC) patients, with a 77.2% AHI responder rate and zero device-related serious adverse events through 12 months.
The study enrolled 47 patients, all of whom were implanted, activated, and completed at least one in-study sleep test.
Nyxoah plans to submit a premarket approval (PMA) supplement to the FDA to expand Genio’s indication to CCC patients under FDA Breakthrough Device Designation.
Results will be presented at the International Surgical Sleep Society (ISSS) annual meeting in October 2026.

The big picture

Nyxoah’s successful ACCCESS study results position the company to address a significant unmet need in the U.S. sleep apnea market, where CCC patients currently lack approved neurostimulation treatment options. The study’s strong efficacy and safety outcomes could expand Genio’s market reach, potentially disrupting the dominance of positive airway pressure (PAP) therapies. The upcoming FDA submission and presentation at the ISSS meeting will be critical milestones in determining Genio’s future adoption.

What we're watching

Regulatory Pathway: Whether Nyxoah’s PMA supplement submission will secure FDA approval for Genio’s expanded indication in CCC patients.
Market Expansion: The pace at which Nyxoah can commercialize Genio for CCC patients in the U.S., following its existing approval in Europe.
Competitive Dynamics: How Genio’s safety and efficacy data will position it against existing sleep apnea treatments in the U.S. market.