Shots:
- The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated
- Approval was based on the DREAM trial, which met its 1 & 2EPs, showing a 63.5% AHI responder rate, 71.3% oxygen desaturation index responder rate, & 70.8% median AHI reduction, with 82% achieving AHI ≤15. Also, AHI was reduced by 66.6% in the supine position & 71.0% in the non-supine position
- Genio System uses bilateral stimulation with a leadless, MRI-compatible design powered by a wearable, component, thereby, eliminating the need of surgeries for technology updates or battery replacements
Ref: Nyxoah| Image: Nyxoah | Press Release
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