Medical technology company Nyxoah SA (Euronext Brussels:NYXH) (Nasdaq:NYXH) announced on Wednesday that it has received an Approvable Letter from the US Food and Drug Administration (FDA) for its Genio system, a neuromodulation treatment for Obstructive Sleep Apnea (OSA).

The letter indicates that Nyxoah's Pre-Market Approval (PMA) application substantially meets the requirements of the Federal Food, Drug and Cosmetic Act, subject to a satisfactory review of manufacturing facilities, methods and controls.

Nyxoah said that it will collaborate with the FDA to address these final requirements and remains committed to making its innovative therapy available to US patients. According to Olivier Taelman, CEO of Nyxoah, the FDA raised no further questions on clinical data or biocompatibility, confirming the company's progress toward US market entry.

This decision does not affect the Genio system's CE Mark or commercial operations in Europe, where it is already approved for both Complete Concentric Collapse (CCC) and non-CCC patients.