04:45 PM EDT, 08/08/2025 (MT Newswires) -- Nyxoah ( NYXH ) said late Friday that the US Food and Drug Administration approved its Genio system for treating moderate to severe obstructive sleep apnea in patients with an Apnea-Hypopnea Index, or AHI, between 15 and 65.

The leadless device uses bilateral stimulation and a non-implanted battery to treat the condition.

The approval was supported by Nyxoah's ( NYXH ) Dream pivotal trial, which met both primary and secondary endpoints. The study showed a 63.5% AHI responder rate, a 71.3% Oxygen Desaturation Index responder rate, and a median AHI reduction of 70.8%.

Additionally, 82% of participants achieved AHI scores below 15, the medical technology company said.

Shares of Nyxoah ( NYXH ) were up more than 12% in after-hours activity.