Nyxoah SA (Euronext Brussels/NASDAQ:NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute (Miami, Florida), serves as the BREATHE Site Principal Investigator.

BREATHE is a multicenter, prospective, single-arm post-approval study designed to assess the long-term safety and effectiveness of the Genio system in adults with moderate to severe OSA. Up to 229 patients will be implanted at up to 25 clinical centers across the United States and followed for up to five years after implantation. The co-primary effectiveness endpoints are the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months. Safety endpoints assess device- and procedure-related serious adverse events at 12 months and annually thereafter.

BREATHE will generate real-world evidence on how Genio performs in routine clinical practice across a broad set of U.S. centers bringing together sleep medicine physicians and ENT surgeons and will contribute to the ongoing evaluation of long-term patient outcomes.

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