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 milestone in the company's efforts to commercialize its innovative treatment for Obstructive Sleep Apnea (OSA) [1][5][6] Company Overview - Nyxoah is a medical technology company focused on developing and commercializing solutions for treating OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [11] - The Genio system is designed to be patient-centered and is compatible with MRI, offering a non-implanted battery solution controlled by a wearable device [10] Recent Developments - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7] - Nyxoah has conducted two successful IPOs, first on Euronext Brussels in September 2020 and then on NASDAQ in July 2021 [7] - The company has expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [7] Clinical Studies and Data - The DREAM U.S. pivotal study data showed a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate and ODI responder rate, indicating the effectiveness of the Genio system [10] - Genio is the only hypoglossal nerve stimulation solution that has demonstrated similar outcomes in both supine and non-supine sleep positions [10] Future Plans - The company plans to present the complete DREAM data at the International Surgical Sleep Society meeting in September 2024 and aims for a U.S. launch of the Genio system by the end of the year [6]