FDA PMA Approval for Genio System
Nyxoah received FDA PMA approval for their Genio system in the United States, marking the first and only bilateral HGNS approved in the U.S. for the treatment of obstructive sleep apnea (OSA).
Significant Revenue Growth
Nyxoah recorded revenue of EUR 1.3 million in Q2 2025, representing an increase of 73.8% compared to EUR 800,000 in Q2 2024.
Successful U.S. Launch Strategy
Nyxoah initiated a focused U.S. launch with over 50 commercial professionals and achieved several VAC and pre-authorization approvals in the first week.
High Patient Satisfaction and Compliance
The DREAM study published in the Journal of Clinical Sleep Medicine showed patient satisfaction scored at 90% and compliance at 85.9%.