Nyxoah SA has received CE Mark approval for the Genio system in Europe.
The Genio system is a battery-free, leadless and minimally invasive neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea (OSA) patients who have failed positive airway pressure (PAP) therapy.
The CE Mark approval was based on data from the Nyxoah 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 7 centers in France and Australia. The BLAST OSA study results will be published in a medical journal later in 2019.
Robert Taub, chairman of the Nyxoah board, says in a release, “Existing therapeutic solutions are often not accepted or are poorly tolerated by patients. The sleep community is looking for alternative solutions for OSA patients who refuse currently available therapies or are not compliant. The Genio system will help many OSA patients in need for a better solution. Having now received CE mark, the Nyxoah Genio system is well on its way to fulfill this need.”
Enrique Vega, Nyxoah SA CEO, says, “Patients from the BLAST OSA study show a major improvement in their sleep apnea symptoms and their quality of life. The BLAST OSA study results and the continuous dedication of the whole Nyxoah team were instrumental in obtaining CE approval, which marks a major milestone for Nyxoah.”
Nyxoah is now 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), where it is currently an investigational device.