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Key takeaways:
- The multicenter, single-arm study will enroll up to 229 patients across up to 25 US centers, following them for up to five years.
- Co-primary effectiveness endpoints include apnea-hypopnea index and oxygen desaturation index responder rates at 12 months.
- The Genio system, a leadless and battery-free hypoglossal neurostimulation therapy, received FDA approval in August 2025.
Medical technology company Nyxoah recently reported that the first patient has been implanted in BREATHE, its US post-approval study of the Genio system for obstructive sleep apnea (OSA).
The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, sleep medicine physician at PharmaDev Clinical Research Institute, 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 US 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.
The study aims to generate real-world evidence on how Genio performs in routine clinical practice across a broad set of US centers, bringing together sleep medicine physicians and ENT surgeons to contribute to the ongoing evaluation of long-term patient outcomes.
“As an otolaryngologist dedicated to the treatment of sleep-disordered breathing, I have seen firsthand the significant impact obstructive sleep apnea has on patients’ health and quality of life. The BREATHE study represents an exciting milestone in the evolution of sleep surgery and neurostimulation therapy,” says Molina in a release. “By performing the first implant in this study, we have the opportunity to help shape the future of sleep apnea treatment while offering eligible patients access to an additional therapeutic approach.”
The Genio system is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA. It received FDA approval in August 2025 as a prescription-only device and has held a European CE Mark since 2019.
“Obstructive sleep apnea affects millions of people, yet many patients continue to struggle despite available therapies. The launch of the BREATHE study marks an exciting step forward in the evolution of sleep medicine, allowing us to evaluate an innovative bilateral hypoglossal nerve stimulation therapy in a real-world setting,” says Mezerhane in a release.
As adoption of the therapy accelerates across US centers, the study will document how it performs in everyday practice over a five-year period.
“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,” says Olivier Taelman, Nyxoah CEO, in a release. “As adoption of Genio accelerates across US centers, BREATHE will document how the therapy performs in everyday practice, in the hands of both sleep physicians and surgeons, over five years. This is the evidence that patients, physicians, and payors expect.”
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