11:21 AM EDT, 07/01/2024 (MT Newswires) -- Nyxoah ( NYXH ) said Monday it has submitted the final module of its premarket approval application for its Genio sleep apnea therapy to the US Food and Drug Administration.

Genio is a hypoglossal nerve stimulation therapy for obstructive sleep apnea that is controlled by a wearable.

The company said the wearable component provides patients with "access to the most advanced technology without needing another surgery."

Nyxoah ( NYXH ) expects to present the complete data on the pivotal study on Genio in September and to prepare for a US launch by the end of 2024, Chief Executive Olivier Taelman said.

Price: 7.15, Change: +0.11, Percent Change: +1.49