On October 6, 2025, Nyxoah SA announced that the first U.S. commercial patients have been successfully implanted with its Genio® system, marking the first commercial use of the device in the United States after FDA approval. The announcement was made at 7:00 CET (1:00 ET) and confirms that the company has moved beyond pre‑authorization and training into actual commercial deployment.
The first implants were performed by Dr. Andrew T. Huang, MD, FACS, Director of Sleep Surgery at Baylor College of Medicine, at Townsen Memorial Health System in Houston, Texas. Dr. Huang completed five Genio® implants in a single week, noting that the procedure time was comparable to his first unilateral HGNS implants and that the device provides a solution for patients who prefer a single incision and no implanted battery.
The press release highlights strong physician demand, successful Value Analysis Committee approvals, and widespread payor coverage, including CMS. These factors indicate that the commercial launch is gaining traction and that the company is building a foundation for sustained adoption, which could translate into early revenue generation and market share gains.
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