REG-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 results from the ACCCESS U.S. pivotal study at ISSS 2026, showing Genio bilateral stimulation delivered a 74.3% median AHI reduction in Complete Concentric Collapse patients. Both co-primary endpoints were met, with a 77.2% AHI responder rate and 87.7% ODI responder rate (p<0.001), and no device- or procedure-related serious adverse events through 12 months. CCC patients currently have no commercially available neurostimulation option in the U.S., and the company has submitted a PMA supplement to the FDA to expand Genio's indication to this population — a potential U.S.
Key figures
- Drug Name
- Genio bilateral stimulation system
- Phase Of Trial
- U.S. pivotal (ACCCESS)
- Sae rate
- 7.5%
- Follow up
- three years post-implant
- Mean ahi 12mo
- 10.4
- Mean ahi baseline
- 33.6
- Ahi responder rate
- 77.2%
- Odi responder rate
- 87.7%
- Device related saes
- 0
- Ahi median reduction
- 74.3%
- Odi median reduction
- 71.9%
- Patient satisfaction
- 97.4%
AI analysis
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