Nyxoah reported that its ACCCESS pivotal study met its primary safety and efficacy endpoints in patients with complete concentric collapse, a form of obstructive sleep apnea excluded from competing nerve-stimulation therapies. Across 47 patients, Genio achieved a 77.2% responder rate on the apnea-hypopnea index, with no device-related serious adverse events. The leadless, battery-free implant stimulates both sides of the hypoglossal nerve to keep the airway open during sleep. Nyxoah is preparing an FDA submission to expand Genio's US indication and has separately begun its BREATHE post-approval study.

Nyxoah completed approximately $110M in June financing, combining a $95M equity raise with a €13.8M second tranche from its European Investment Bank loan facility. The capital addresses a pressing funding need. As of March 31st, the company held €25.9M in cash against a quarterly operating loss near €20M, with management flagging going-concern doubt and a runway extending only into Q3 2026. The new financing is aimed primarily at the US commercial launch of Genio, its hypoglossal nerve stimulation system for obstructive sleep apnea, which received FDA approval in August 2025.