Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA

Core Insights - Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application for the Genio® system to the U.S. FDA, marking a significant step towards U.S. commercialization [4][9] - The Genio® system, which received its European CE Mark in 2019, is a leadless and battery-free hypoglossal neurostimulation therapy designed to treat Obstructive Sleep Apnea (OSA) [1][10] - The company has successfully completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [1] Company Developments - Following the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, a group currently excluded from competitors' therapies [1] - The DREAM IDE pivotal study is currently underway to support FDA approval and U.S. commercialization of the Genio® system [1][4] - The company aims to present complete DREAM study data at the International Surgical Sleep Society meeting in September 2024, with plans for a U.S. launch by the end of the year [9] Product Features - The Genio® system is characterized by its leadless design, full-body MRI compatibility, and a non-implanted battery solution, which is powered and controlled by a wearable device [10][14] - The system's wearable component is fully upgradable, allowing patients to access the latest technology without the need for additional surgeries [14] - Recent data from the DREAM U.S. pivotal study indicated a statistically significant reduction in the co-primary endpoints, including the 12-month AHI responder rate and ODI responder rate [14]