I previously described efforts by Nyxoah, which was founded in 2009 by Robert Taub and Dr. Adi Mashiach in Mont-Saint-Guibert, Belgium, to develop neurostimulation treatments focused for Obstructive Sleep Apnea.
Nyxoah developed a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage during sleep. The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that carries an “Activation Chip” that is positioned every night by the patient under the chin. The Activation Chip has its own battery and has enough energy to wirelessly activate the implanted neurostimulator for a full night sleep session.
On March 19, 2019, Nyxoah announced that the company has received CE Mark approval for the Genio® system. According to the press release:
“The Genio® system is the world’s first and only battery-free, leadless and minimally invasive neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe OSA patients who have failed conventional 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 leading medical journal later in 2019.
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).”