Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe 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. According to the FDA, OSA is an irreversibly debilitating human disease for patients with sleep apnea. 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 US.
“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,” said Olivier Taelman, CEO of Nyxoah. “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.