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 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 were up more than 12% in after-hours activity.