Nyxoah reports 12-month ACCCESS study data at ISSS meeting

Nyxoah SA (Nasdaq: NYXH) announced that complete 12-month results from the ACCCESS U.S. pivotal study were presented at the International Surgical Sleep Society annual meeting in Los Angeles on October 15, 2026.

The study evaluated the Genio bilateral hypoglossal neurostimulation system in adults with moderate to severe obstructive sleep apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate. CCC patients are currently contraindicated for unilateral hypoglossal nerve stimulation in the United States, and no commercially available neurostimulation option exists for this population domestically.

Both co-primary efficacy endpoints were met. The Apnea-Hypopnea Index (AHI) responder rate reached 77.2% and the Oxygen Desaturation Index (ODI) responder rate reached 87.7%, both on a Full Analysis Set basis (p<0.001). In the per protocol population, mean AHI decreased from 33.6 to 10.4 events per hour, a median reduction of 74.3% from baseline, while mean ODI fell from 32.6 to 10.9 events per hour, a median reduction of 71.9%.

No device- or procedure-related serious adverse events were reported through 12 months. Four serious adverse events were recorded, all deemed unrelated to the device or procedure, reflecting an overall serious adverse event rate of 7.5%.

Patient-reported outcomes showed mean Epworth Sleepiness Scale scores improved by 5.3 points and mean Functional Outcomes of Sleep Questionnaire scores improved by 2.3 points (both p<0.001). Among patients, 94.7% reported improvement and 97.4% said they were satisfied and would choose the implant again.

Nyxoah said it has submitted a premarket approval supplement to the U.S. Food and Drug Administration to expand Genio's indication to CCC patients. Study participants will continue to be followed for three years post-implant.

The Genio system has been approved for CCC patients in Europe since 2021 and received FDA approval in August 2025, though CCC patient treatment is currently included in the warnings section of its U.S. indications for use.

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