Following FDA approval of the Genio system in August 2025, Nyxoah is executing its U.S. commercial launch. The strategy focuses on targeting 400 high-volume hypoglossal nerve implanting accounts, with over 125 accounts already covered by trained surgeons as of early 2026.

Expected impact: To drive rapid adoption of the Genio system in the $10 billion U.S. market and achieve sequential U.S. net revenue growth of 25-30% quarter-over-quarter.

Nyxoah is expanding its manufacturing footprint in Wallonia, Belgium, by establishing a new 2,000 square meter facility, including a state-of-the-art cleanroom. This facility is designed to be scalable to support product development and meet growing global demand.

Expected impact: To scale manufacturing capacity to support U.S. and international growth while strengthening the company's long-term gross margin profile.

Nyxoah is selectively expanding its commercial footprint outside the U.S. and Europe, with initial target entry points into the Asian market starting with the UAE and Singapore.

Expected impact: To establish early market presence in high-potential international regions and diversify revenue streams.