Nyxoah Launches Large-Scale U.S. Study to Track Genio System's…

Event summary

Nyxoah initiated the BREATHE study, a U.S. post-approval trial for its Genio® system, with the first patient implanted on September 7, 2026.
The study will enroll up to 229 patients across 25 U.S. centers, with follow-up extending up to five years.
Primary endpoints include Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months.
The study aims to generate real-world evidence on Genio's safety and effectiveness in routine clinical practice.

The big picture

Nyxoah's BREATHE study represents a critical step in establishing the Genio system as a long-term solution for moderate to severe obstructive sleep apnea (OSA) in the U.S. The study's scale and duration will provide valuable real-world data, addressing a key gap in the competitive landscape of neuromodulation therapies. With FDA approval secured, Nyxoah is now focused on demonstrating sustained efficacy and safety to solidify its position against established players in the sleep apnea treatment market.

What we're watching

Clinical Evidence: How the BREATHE study's long-term data will influence Genio's adoption among U.S. physicians and payors.
Market Penetration: Whether Nyxoah can sustain momentum in the U.S. market following FDA approval in August 2025.
Competitive Dynamics: The pace at which Nyxoah expands its therapeutic indications, particularly for Complete Concentric Collapse (CCC) patients.