Nyxoah enrolls first patient in US BREATHE study evaluating Genio OSA system
Nyxoah plans to enrol and implant up to 229 patients at as many as 25 sites, with participants receiving follow-up for up to five years after implantation.
USA—Belgian medical technology company Nyxoah has implanted the first patient in BREATHE, a US post-approval study evaluating the Genio system in adults with moderate to severe obstructive sleep apnoea (OSA).
The procedure was performed by Rolando Molina, an otolaryngologist at South Florida ENT Associates.
Edward Mezerhane, a sleep medicine physician at PharmaDev Clinical Research Institute, is serving as the study’s principal investigator at the site.
Study to Enrol Up to 229 Patients
BREATHE is a prospective, single-arm study that will be conducted across multiple clinical centres in the United States.
Nyxoah plans to enrol and implant up to 229 patients at as many as 25 sites, with participants receiving follow-up for up to five years after implantation.
The study will assess the effectiveness and safety of the Genio system in routine clinical practice across a range of US healthcare settings.
The study has two co-primary effectiveness endpoints, based on responder rates for the Apnoea Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI).
Researchers will assess both measures at 12 months after implantation.
Safety assessments will focus on serious adverse events related to the device or implantation procedure at 12 months.
Researchers will continue these assessments annually throughout the follow-up period.
Generating Real-World Evidence
According to Nyxoah, BREATHE will provide real-world evidence on the Genio system’s performance outside the controlled environment of a pivotal clinical trial.
The study will involve both sleep medicine physicians and ear, nose and throat surgeons at multiple US centres.
This approach will allow researchers to assess how the therapy performs across different clinical settings and among healthcare professionals with different areas of expertise.
The study will also contribute to the company’s ongoing assessment of long-term outcomes among patients receiving the therapy.
Nyxoah CEO Olivier Taelman said the first BREATHE implantation marks the beginning of the company’s largest prospective study of the Genio system to date.
He added that the study would expand the long-term evidence base for bilateral hypoglossal nerve stimulation in the United States.
“As adoption of Genio accelerates across US centres, BREATHE will document how the therapy performs in everyday practice, in the hands of both sleep physicians and surgeons, over five years,” Taelman said.
Genio System Development
The Genio system is a leadless, battery-free device designed to provide hypoglossal nerve stimulation for people with OSA.
Nyxoah received the CE Mark for the system in 2019 following the BLAST OSA study.
The company later expanded its European indication to include patients with complete concentric collapse following the BETTER SLEEP study.
Nyxoah reported positive results from its DREAM IDE pivotal study in 2024.
The US Food and Drug Administration subsequently approved the Genio system in August 2025, allowing the company to expand its commercial presence in the US market.
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