Nyxoah: American ACCCESS study achieves efficacy and safety criteria, according to the company
Nyxoah announced on September 2, 2026 that its pivotal American ACCCESS study had achieved its co-primary efficacy endpoints and safety criteria in patients suffering from complete concentric collapse (CCC) of the soft palate.
ACCCESS is a multicenter, prospective, open-label study with patients followed for three years.
Responder rate of 77.2% and no serious device-related adverse events
At twelve months, patients demonstrated a responder rate on the apnea-hypopnea index (AHI), according to Sher criteria, of 77.2% (p less than 0.001), and a responder rate on the oxygen desaturation index (ODI) of 87.7% (p less than 0.001), both measured on the basis of the Full Analysis Set.
On the safety front, no serious device-related adverse events were reported during the twelve months following implantation.
The primary analysis covered a set of 47 patients, that is, all those who had been implanted, activated and who completed at least one sleep test (polysomnography) during the study. Missing data were handled through a multiple imputation model, a statistical method predefined in the protocol approved by the FDA.
CCC patients: no neuromodulation option in the United States to date
The ACCCESS study was designed to support the expansion of the American indication of the Genio system to CCC patients, currently contraindicated for unilateral hypoglossal nerve neuromodulation commercialized in that country.
The Genio system has been approved for CCC patients in Europe since 2021, following the BETTER SLEEP study, while in the United States no neuromodulation option exists for this population.
The company had indicated in August 2025 that it had closed patient enrollment before the maximum planned 106 patients. According to Olivier Taelman, Chief Executive Officer of Nyxoah, these results confirm the efficacy and safety sought for this population.
Preparing an application to the FDA under Breakthrough Device status
Nyxoah indicated it is preparing a Premarket Approval (PMA) supplement application with the FDA to expand the indication of Genio to CCC patients, under the FDA's Breakthrough Device designation.
The complete twelve-month dataset and detailed results are to be presented at the annual meeting of the International Surgical Sleep Society (ISSS) in Los Angeles, on October 15 and 16, 2026.
This result comes in the context of scaling up Genio's commercialization in the United States, following FDA approval obtained in August 2025. Nyxoah had published on August 5, 2026 revenue of €14 million for the first half of 2026.
