Research & Development
Nyxoah passes European CE Mark for the Genio System obstructive sleep apnea therapy
20 March 2019 -

Healthtech company Nyxoah SA reported on Tuesday the receipt of the CE Mark approval for the Genio system in Europe, for treating obstructive sleep apnea.

Headquartered in Mont-Saint-Guibert, Belgium, the company said the Genio system is the world's first and only battery-free, leadless and minimally invasive neurostimulator, which delivers bilateral hypoglossal nerve stimulation for moderate to severe OSA patients who have failed Positive Airway Pressure (PAP) therapy.

This CE Mark approval was based on data from the company's BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study. The BLAST OSA trial is a prospective study that evaluated the safety and performance of the Genio system in seven centres in France and Australia.

In conjunction, the BLAST OSA study results will be published in a leading medical journal later in 2019.

Currently, the company is focusing on gathering additional clinical evidence on the Genio system, initiating European market development activities and working toward gaining approval by the US Food and Drug Administration (FDA).



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