Nyxoah enrolls first patient in U.S. post-approval Genio study

Nyxoah SA (Nasdaq: NYXH) announced that the first patient has been implanted in BREATHE, its U.S. post-approval study of the Genio system, a hypoglossal nerve stimulation device for obstructive sleep apnea.

The procedure was performed by Rolando Molina, MD, an otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, a sleep medicine physician at PharmaDev Clinical Research Institute in Miami, Florida, serves as the site principal investigator.

BREATHE is a multicenter, prospective, single-arm study designed to assess the long-term safety and effectiveness of the Genio system in adults with moderate to severe obstructive sleep apnea. The study plans to enroll up to 229 patients across up to 25 U.S. clinical centers, with participants followed for up to five years after implantation.

The co-primary effectiveness endpoints are the Apnea-Hypopnea Index and Oxygen Desaturation Index responder rates at 12 months. Safety endpoints assess device- and procedure-related serious adverse events at 12 months and annually thereafter.

"The first BREATHE implant marks the start of the largest prospective study of Genio to date and the next step in building the long-term, real-world evidence base for bilateral hypoglossal nerve stimulation in the United States," said Olivier Taelman, chief executive officer of Nyxoah.

The Genio system received FDA approval in August 2025 and is classified as a prescription-only device. It previously received a CE Mark in Europe in 2019. According to the company, the device is leadless and battery-free.

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