Full 12-Month Data from the ACCCESS U.S. Pivotal Study in Complete Concentric Collapse Patients Presented at ISSS 2026
Nyxoah presented full 12-month ACCCESS pivotal study results at ISSS 2026, showing Genio bilateral stimulation delivered a 74.3% median reduction in AHI with no device- or procedure-related serious adverse events. Both co-primary endpoints were met, with a 77.2% AHI responder rate and 87.7% ODI responder rate (p<0.001), targeting Complete Concentric Collapse patients who currently have no commercially available neurostimulation option in the U.S. Nyxoah has submitted a PMA supplement to the FDA to expand Genio's U.S.
Key figures
- Drug Name
- Genio bilateral stimulation system
- Phase Of Trial
- U.S. pivotal (ACCCESS)
- Overall sae rate
- 7.5%
- Regulatory action
- PMA supplement submitted to FDA to expand indication to CCC patients
- Odi responder rate
- 87.7%
- Ess improvement points
- 5.3
- Ahi responder rate sher
- 77.2%
- Ahi median reduction 12m
- 74.3%
- Patient satisfaction rate
- 97.4%
- Device or procedure related saes
- 0
- Mean ahi reduction events per hr
- 33.6 to 10.4
- Mean odi reduction events per hr
- 32.6 to 10.9
AI analysis
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