Nyxoah anticipates FDA approval for Genio system in Q2

Nyxoah (NYXH) announced an update on the FDA approval process for the Genio system. On March 26, the company announced that the FDA issued an approvable letter regarding the company’s pre-market approval application for the Genio system. The approvable letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including the clinical study that demonstrates the safety and effectiveness of the Genio system. Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.