Nyxoah has submitted the final module of its Premarket Approval application for its Genio neurostimulator.


Summary:

Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application to the FDA for its Genio neurostimulator, designed to treat obstructive sleep apnea (OSA). The Genio system, which is fully-body MRI-compatible and powered by a wearable, demonstrated significant efficacy in the DREAM US pivotal study. Nyxoah aims to launch Genio in the US by the end of 2024, following positive outcomes in previous studies and receiving the European CE Mark in 2019.

Three Key Takeaways:

  • Final PMA Submission: Nyxoah has completed the final module of its PMA application for the Genio neurostimulator, moving closer to FDA approval for its OSA treatment.
  • Features: The Genio system offers a leadless, MRI-compatible, wearable-powered solution for hypoglossal nerve stimulation, eliminating the need for implanted batteries.
  • Proven Efficacy: The Genio neurostimulator showed improvements in sleep apnea metrics in the DREAM US pivotal study and is already CE Mark approved in Europe.

Nyxoah, a medical technology company focused on developing solutions to treat obstructive sleep apnea (OSA), submitted the fourth and final module of its Premarket Approval (PMA) application for its lead solution, the Genio neurostimulator for OSA, to the US Food and Drug Administration (FDA).

Genio is a different approach to hypoglossal nerve stimulation. Genio offers patients a leadless, fully-body MRI-compatible, non-implanted battery solution, powered and controlled by a wearable. Thanks to the fully upgradable wearable component, Genio patients can always have access to the latest technology without needing another surgery. 

In March, Nyxoah announced the DREAM US pivotal study data achieved a statistically significant reduction in the co-primary endpoints of 12-month apnea-hypopnea index responder rate, per the Sher criteria, and oxygen desaturation index responder rate, both on an intent-to-treat basis, and that Genio is the only hypoglossal nerve stimulation solution to show similar outcomes in supine and non-supine sleep.

CEO’s Vision and Future Plans

“I am proud to achieve this important milestone, which brings us one step closer to offering Genio to obstructive sleep apnea patients in the US. I would like to congratulate our entire team on their hard work in completing the PMA submission. I could not be more excited for the remainder of 2024, which includes presenting the complete DREAM data at the International Surgical Sleep Society meeting in September and preparing for a US launch by the end of the year,” says Olivier Taelman, Nyxoah’s chief executive officer, in a release. 

Following the completion of the BLAST OSA study, the Genio system received its European CE Mark in 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. 

It is currently an investigational device in the United States. Additionally, Nyxoah is conducting the DREAM IDE pivotal study for FDA and US commercialization approval.