Nyxoah Updates on FDA Approval Process for Genio System

Nyxoah SA, a medical technology company from Belgium, has provided an update on the FDA approval process for its Genio system, ahead of a potential market debut in the United States. The company received an Approvable Letter from the FDA, indicating significant progress in meeting key regulatory requirements under the Federal Food, Drug and Cosmetic Act.

The primary remaining step before full approval involves validation of a process related to a Genio component at the U.S. manufacturing site. Nyxoah expects to complete this validation soon, and foresees FDA approval potentially in the second quarter. Chief Executive Officer Olivier Taelman expressed confidence in resolving the final requirements, aiming for a U.S. launch post-approval. Updates will follow in the first quarter 2025 earnings call.