Nyxoah SA (NYXH) shares jumped 15% in Wednesday trading after it said its ACCCESS US pivotal study met its co-primary efficacy endpoints and safety endpoints in patients with Complete Concentric Collapse, a pattern of airway collapse that currently contraindicates patients for commercially available unilateral hypoglossal nerve stimulation in the US.

At 12 months, patients showed a 77.2% responder rate on the Apnea-Hypopnea Index, a measure of breathing interruptions during sleep and an 87.7% responder rate on the Oxygen Desaturation Index, a measure of drops in blood oxygen, both statistically significant, the company said.

No device-related serious adverse events were reported through 12 months post-implant, according to the company.

The study supports expanding the US indication for Nyxoah's Genio system, an implanted device that stimulates a nerve in the tongue to keep the airway open during sleep, to CCC patients, the company said, adding it is preparing a premarket approval supplement submission to the FDA.