on Nyxoah SA. (isin : BE0974358906)
FDA Approvable Letter Issued to Nyxoah for Genio® System
Mont-Saint-Guibert, Belgium, March 26, 2025 – Nyxoah SA announced that the U.S. FDA has issued an Approvable Letter for its Genio® system. This indicates that Nyxoah's Pre-Market Approval application substantially meets Federal Food, Drug, and Cosmetic Act requirements, pending a satisfactory manufacturing review.
CEO Olivier Taelman noted the absence of further questions regarding clinical data or biocompatibility, emphasizing the commitment to make Genio available to U.S. Obstructive Sleep Apnea patients. The CE Mark and European operations remain unaffected.
Genio® offers innovations in hypoglossal neurostimulation therapy for OSA. Nyxoah has been active in Europe since 2019 and is now seeking a US market entry following recent positive study outcomes.
R. H.
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