Summary: Nyxoah has received an approvable letter from the FDA for its Genio neurostimulator for sleep apnea, pending successful completion of a final manufacturing process validation at its US site.
Key Takeaways:
- Nyxoah’s Genio neurostimulator for obstructive sleep apnea substantially meets FDA pre-market approval requirements, with just one final hurdle remaining.
- FDA accepted Nyxoah’s clinical study data demonstrating Genio’s safety and effectiveness
- Genio is distinctive as a leadless, battery-free hypoglossal neurostimulator approved in Europe for obstructive sleep apnea, including patients with complete concentric collapse—a group contraindicated by competitors’ devices.
The Food and Drug Administration (FDA) has issued Nyxoah SA an approvable letter regarding the company’s pre-market approval application for the Genio system, meaning that the application substantially meets requirements—but the FDA will only approve the application subject to satisfactory completion of a manufacturing facilities, methods, and controls review.
The FDA has accepted the other data provided with the pre-market approval submission of the neurostimulator for obstructive sleep apnea, including the clinical study demonstrating the safety and effectiveness of the Genio system, which has been European CE Marked since 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to complete concentric collapse patients, currently contraindicated in competitors’ therapy.
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 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 FDA confirms that we are very close to [pre-market approval],” says Olivier Taelman, Nyxoah’s CEO, in a release. “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 FDA—which we are confident we can address swiftly and successfully. We look forward to launching Genio in the US upon receipt of FDA approval.”
Nyxoah’s lead solution is the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea.
