Nyxoah: 77.2% of Responders at 12 Months for Genio, Application Submitted to FDA

Both Primary Efficacy Co-Endpoints Met at 12 Months

The ACCCESS study focuses on Genio bilateral stimulation in patients with obstructive sleep apnea presenting complete concentric collapse (CCC) of the soft palate. According to Nyxoah, both primary efficacy co-endpoints were achieved in the full analysis population.

The responder rate on the Apnea-Hypopnea Index (AHI), measured according to Sher criteria, stands at 77.2%. The responder rate on the Oxygen Desaturation Index (ODI) reaches 87.7%. Stimulation furthermore enabled a median reduction of 74.3% in AHI at 12 months.

These complete data confirm the preliminary results announced on September 2, 2026.

No Serious Device-Related Events, Application Submitted to FDA

On the safety front, the company indicates that no serious adverse events related to the device or procedure were recorded at 12 months.

On this basis, Nyxoah submitted a PMA supplement to the Food and Drug Administration (FDA) to extend Genio's indication to CCC patients. At this stage, this is an application submitted to the American regulator: the indication extension has not yet been granted.

The company specifies that patients presenting complete concentric collapse of the soft palate constitute a population for which no neurostimulation option is currently commercially available in the United States.