Utrecht, The Netherlands and Mont-Saint-Guibert, Belgium – 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™ system in Europe. 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 obstructive sleep apnea (OSA) patients who have failed conventional therapy.
The CE Mark approval was based on the BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study, a prospective study that evaluated the safety and performance of the Genio™ system in 7 centers in France and Australia.
“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.
Robert Taub, Chairman of Nyxoah said: “The sleep community is looking for alternative solutions for OSA patients who refuse currently available therapies or are not compliant. Having now received CE mark, Nyxoah’s Genio™ system is well on its way to fulfil this need”.
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 www.nyxoah.com.
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing €1 billion across two business lines: a venture & growth capital fund and a private equity fund. Gilde Healthcare’s venture & growth capital fund invests in healthtech and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European healthcare services companies with a focus on the Benelux and DACH-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com