REG-Nyxoah Announces First Patient Implanted in BREATHE, the U.S. Post-Approval Study of the Genio® System
Nyxoah implanted the first patient in BREATHE, its U.S. post-approval study of the Genio hypoglossal nerve stimulation system for moderate to severe obstructive sleep apnea, with the procedure performed by Rolando Molina, MD, of South Florida ENT Associates. The multicenter study plans to implant up to 229 patients at up to 25 U.S. centers with follow-up of up to five years, using AHI and ODI responder rates at 12 months as co-primary effectiveness endpoints.
Key figures
- Drug Name
- Genio system
- Phase Of Trial
- Post-approval study
- Study name
- BREATHE
- Centers planned
- up to 25 U.S. centers
- Safety endpoint
- device- and procedure-related serious adverse events at 12 months and annually thereafter
- Patients planned
- up to 229
- Follow up duration
- up to five years
- Co primary endpoints
- AHI and ODI responder rates at 12 months
AI analysis
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