Nyxoah Announces First U.S. Commercial Patients Implanted with Genio® System

Core Insights - Nyxoah has successfully implanted the first U.S. commercial patients with the Genio® system, marking a significant milestone in the treatment of Obstructive Sleep Apnea (OSA) [1][2] - The company has achieved strong physician demand, successful pre-authorizations, and widespread payor coverage, including approvals from major payors like CMS [2] - The Genio system is a leadless and battery-free hypoglossal neurostimulation therapy, aimed at providing innovative solutions for OSA patients [3] Company Overview - Nyxoah is focused on developing and commercializing innovative solutions for OSA, with the Genio system as its lead product [3] - The company aims to improve the quality of life for OSA patients by providing effective treatment options [3] Product Development and Approval - The Genio system received its European CE Mark in 2019 and U.S. FDA approval in August 2025 as a prescription-only device [4][5] - The company has completed two successful IPOs, on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] Market Indicators - Nyxoah is tracking several metrics as leading indicators of future revenue growth, including the number of trained surgeons, value analysis committee submissions, prior authorization submissions, and accounts opened [7]