On August 8, 2025, Nyxoah SA announced FDA approval for its Genio® system, designed for adult patients with moderate to severe Obstructive Sleep Apnea (OSA) with specific Apnea-Hypopnea Index levels. The company also reported a projected revenue of approximately €1.3 million for Q2 2025, a 73% increase from the previous year, and is transitioning its R&D from Israel to the U.S. and Belgium.