Shots:
- Nyxoah announced the first patient implantation in BREATHE, its US post-approval study evaluating the long-term safety and effectiveness of the Genio System in adults with moderate to severe obstructive sleep apnea (OSA)
- The prospective, multicenter study plans to implant up to 229 pts. across up to 25 US centres, with follow-up for up to five years; co-primary effectiveness endpoints include AHI and ODI responder rates at 12 months
- BREATHE will assess device- and procedure-related serious AEs at 12 months and annually thereafter, while generating RWE on bilateral hypoglossal nerve stimulation with Genio in routine US clinical practice
Ref: GlobeNewswire | Image: Nyxoah | Press Release
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