Nyxoah(NYXH) Newsfilter·2025-04-08 05:00Core Viewpoint - Nyxoah is nearing full FDA approval for its Genio system, with expectations to meet final requirements in the second quarter of 2025 [1][4]. Group 1: FDA Approval Process - On March 26, 2025, the FDA issued an Approvable Letter for Nyxoah's Pre-Market Approval (PMA) application for the Genio system [2]. - The Approvable Letter indicates that the application substantially meets FDA requirements, pending satisfactory completion of a review of manufacturing facilities and methods [3]. - Nyxoah is addressing one remaining item related to the validation of a process at its U.S. manufacturing site, which is expected to be completed soon [4]. Group 2: Company Background and Product Information - Nyxoah specializes in developing innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation, with the Genio system being a leadless and battery-free hypoglossal neurostimulation therapy [6]. - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7]. - The company has conducted successful IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and has expanded its therapeutic indications based on positive study outcomes [7].