Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, March 19 2019 - 19:00
Nyxoah Receives European CE Mark Approval for the Genio® System, a Disruptive Neurostimulation Solution for Obstructive Sleep Apnea Therapy
SAINT-GUIBERT, Belgium, March 19, 2019 /PRNewswire-AsiaNet/ --

     Nyxoah S.A., a healthtech company focusing on the development of 
innovative solutions and services for sleep related disorders, today announced 
that the company has received CE Mark approval for the Genio(R) system in 

    The Genio(R) 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(R) system in 7 centers in France and 
Australia. The BLAST OSA study results will be published in a leading medical 
journal later in 2019.

    Robert Taub, Chairman of the Nyxoah Board said: "Obstructive Sleep Apnea 
(OSA) is the most common Sleep Disordered Breathing condition. International 
sleep experts recently estimated that nearly 1 Billion people worldwide suffer 
from sleep apnea. 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(R) system will help many OSA patients in need for a better 
solution. Having now received CE mark, the Nyxoah Genio(R) system is well on 
its way to fulfil this need."

    "Patients from the BLAST OSA study show a major improvement in their sleep 
apnea symptoms and their Quality of Life," said Enrique Vega, Chief Executive 
Officer of Nyxoah S.A. "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(R) system, initiating European market development activities and working 
toward gaining approval by the US Food and Drug Administration (FDA).

    About Nyxoah Nyxoah S.A., headquarted in Mont-Saint-Guibert - Belgium, is a 
healthtech company focused on the development of innovative, 
neurostimulation-based solutions and services for sleep related disorders. 
Nyxoah S.A. was co-founded in 2009 by Robert Taub.

    For more information, please visit

    Caution - Investigational device in the USA. Limited by federal law to 
investigational use.

SOURCE: Nyxoah