FDA Issues Nyxoah an Approvable Letter for its Genio® System

Core Insights - The FDA has issued an Approvable Letter for Nyxoah's Genio® system, indicating that the application substantially meets the necessary requirements for marketing in the U.S. [3][4] - The approval is contingent upon the satisfactory completion of a review of manufacturing facilities, methods, and controls [4][5] - Nyxoah's CEO expressed confidence in the approval process, noting that there were no further questions regarding clinical data or biocompatibility [5] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA) through neuromodulation [6] - The Genio® system is a leadless, battery-free hypoglossal neurostimulation therapy designed for OSA patients [6] - The company aims to improve the quality of life for OSA patients, who face increased mortality risk and cardiovascular issues [6] Regulatory and Market Position - The Genio® system received its European CE Mark in 2019 and has been approved for both Complete Concentric Collapse (CCC) and non-CCC patients [7] - Nyxoah has successfully completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [7] - The company has reported positive outcomes from clinical studies, including the BETTER SLEEP study and the DREAM IDE pivotal study [7]