"Nyxoah SA, a medical technology company focused on the development and commercialization of innovative solutions for breakthrough treatment alternatives for obstructive sleep apnea through neuromodulation, announced an update on the US FDA approval process for the Genio system.
On March 26, 2025, the company announced that the US Food and Drug Administration issued an approvable letter regarding the company’s pre-market approval (PMA) 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 US FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the US FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. US FDA has accepted all other data provided with the pre-market approval submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio system.
Nyxoah is actively addressing one remaining item before US FDA approval may be granted which is the validation of one process used with a component of the Genio system at its US 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.
“We are pleased to share that the approvable letter from US FDA confirms that we are very close to pre-market approval approval,” commented Olivier Taelman, Nyxoah’s CEO. “We believe the final remaining step is completing a process validation at our US manufacturing site – action taken in response to the last set of specific validation questions sent by the US FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the US upon receipt of US FDA approval.
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