(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company submitted the fourth and final module of its Premarket Approval (PMA) application for Genio to the U.S. Food and Drug Administration (FDA).
Genio is a different approach to hypoglossal nerve stimulation (HGNS). 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 most advanced technology without needing another surgery. In March 2024, Nyxoah announced the DREAM U.S. pivotal study data achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an intent-to-treat basis, and that Genio is the only HGNS solution to show similar outcomes in supine and non-supine sleep.
“I am proud to achieve this important milestone, which brings us one step closer to offering Genio to obstructive sleep apnea patients in the U.S. 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 U.S. launch by the end of the year,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.