Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

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…

ByPrince GiriSeptember 8, 2026

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Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

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…

ByRidhi RastogiAugust 11, 2025

Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

Nyxoah Receives the US FDA Approval for Genio System to Treat Obstructive Sleep Apnea

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