04:38 AM EDT, 04/08/2025 (MT Newswires) -- Nyxoah ( NYXH ) said Tuesday it is actively addressing the validation of a process used with a component of its Genie obstructive sleep apnea treatment device at its US manufacturing site ahead of potential US Food and Drug Administration marketing approval.

The company said it is confident of completing the validation in the near term, with the application approval likely in Q2.

The FDA late last month issued an approvable letter with regard to Genio's pre-market approval application.

Nyxoah ( NYXH ) shares were up nearly 23% in recent premarket activity.