Belgium-based medical technology company Nyxoah has implanted the first patient in BREATHE, its US post-approval study of the Genio system for obstructive sleep apnoea (OSA).
The procedure was carried out by South Florida ENT Associates otolaryngologist Rolando Molina.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
PharmaDev Clinical Research Institute sleep medicine physician Edward Mezerhane is acting as site principal investigator for the study.
BREATHE is a single-arm, prospective study running across multiple centres. Nyxoah plans to implant up to 229 patients at as many as 25 clinical sites in the US, with follow-up lasting up to five years after the procedure.
Participants are adults with moderate to severe OSA.
The study has two co-primary effectiveness endpoints: responder rates for the Apnoea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI), both measured at 12 months.
Safety will be assessed through device- and procedure-related serious adverse events at 12 months and on an annual basis thereafter.
The study is intended to gather real-world evidence on how the Genio system performs in routine clinical practice at a range of US centres involving both sleep medicine physicians and ear, nose, and throat (ENT) surgeons.
It will also feed into continuing assessment of long-term patient outcomes.
Nyxoah CEO Olivier Taelman said: “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 US.
“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.
“This is the evidence that patients, physicians and payors expect, and it reflects our commitment to clinical rigour beyond approval.”
The Genio system is a leadless, battery-free hypoglossal neurostimulation therapy.
It received CE Mark in 2019 following the BLAST OSA study, and a subsequent approval for the expansion covering patients with Complete Concentric Collapse after the BETTER SLEEP study.
Nyxoah reported positive results from its DREAM IDE pivotal study in 2024 and obtained approval from the US Food and Drug Administration in August 2025.
