Nyxoah's Genio reduces median apnea-hypopnea index 74.3% in 12-month study of CCC patients
NYXH•Nyxoah said its Genio device reduced median apnea-hypopnea index by 74.3% in a 12-month study of obstructive sleep apnea patients with complete concentric collapse. The company said the study met both primary efficacy endpoints, with no device- or procedure-related serious adverse events through 12 months.
1. Study results
Nyxoah presented full 12-month results from its ACCCESS pivotal study of Genio at the ISSS meeting on October 15, 2026. The device met both primary efficacy endpoints in obstructive sleep apnea patients with complete concentric collapse and reduced breathing disruptions during sleep.
2. Safety and FDA application
No device- or procedure-related serious adverse events occurred through 12 months. Patients reported reduced daytime sleepiness and improved quality of life. Nyxoah has submitted a supplemental FDA application seeking to expand Genio’s indication to these patients, who lack a commercially available US neurostimulation option.
