The US Food and Drug Administration (FDA) has granted Nyxoah SA’s Genio bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe obstructive sleep apnea (OSA) and complete concentric collapse (CCC) of the soft palate.
The FDA’s Breakthrough Designation Program was created to help patients and healthcare providers receive faster access to innovative technologies that hold the potential to provide more effective treatment of irreversibly debilitating diseases or conditions. Under the program, the FDA will provide the Genio system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the United States.
“We are pleased to have received Breakthrough Device Designation for our proprietary Genio system for OSA patients with CCC, recognizing that obstructive sleep apnea is an irreversibly debilitating condition,” says Olivier Taelman, CEO of Nyxoah, in a release. “This Breakthrough Designation accelerates our market authorization process in the US and expands our total addressable market to include CCC patients currently contraindicated for hypoglossal nerve stimulation.”
The Breakthrough Designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and performance of the Genio system in adult OSA patients with and without CCC.
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea, or BETTER SLEEP, is a multicenter, prospective, open-label, two-group clinical trial, designed to assess the safety and performance of the Genio system for the treatment of OSA in adult patients with and without complete concentric collapse. Top-line BETTER SLEEP results showed primary safety and performance endpoints were met, with statistically significant mean reduction in the AHI score in full patient population including complete concentric collapse patients. Nyxoah will submit full BETTER SLEEP study data to a medical journal for publication and announce results following further analyses.