Nyxoah's Genio Hypoglossal Nerve Stimulator Receives CE Mark for Obstructive Sleep Apnea Treatment

VCBeat (WeChat ID: vcbeat) has learned that medical device company Nyxoah recently announced that its medical device, Genio, has received CE certification. The device is a novel hypoglossal nerve stimulation therapy for the treatment of obstructive sleep apnea (OSA).

Nyxoah, founded in 2009, is a medical device company headquartered in Walloon Brabant, Belgium, specializing in the development of hypoglossal nerve stimulation (HGNS) therapy. Obstructive sleep apnea (OSA) is one of the key conditions addressed by the company, which aims to free OSA patients from the burdens of complex surgical procedures and high medical costs.

Genio is a leadless, battery-free, minimally invasive neurostimulator designed to provide bilateral hypoglossal nerve stimulation therapy for patients with moderate to severe obstructive sleep apnea (OSA) who have failed conventional continuous positive airway pressure (CPAP) therapy. Abnormal relaxation of the tongue and throat muscles is a common cause of OSA; the device is implanted in the chin area and uses electrical currents to stimulate the hypoglossal nerve, keeping the upper airway open throughout the night and preventing airway obstruction. Compared with traditional neurostimulation devices, Genio offers the advantages of lower cost, easier implantation, and reduced risk.

Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized primarily by snoring accompanied by apneas during sleep and excessive daytime sleepiness, with a prevalence of 2%–4%. This condition causes intermittent hypoxia, hypercapnia, and disruption of sleep architecture, and can lead to various comorbidities, including hypertension, coronary heart disease, arrhythmias, cerebrovascular disease, cognitive impairment, and type 2 diabetes. OSA inflicts damage on multiple bodily systems, making it a true systemic disease.

Robert Taub, Chairman of the Board of Nyxoah, stated: “The CE marking for Genio represents a significant milestone for Nyxoah. Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. Recently, international sleep experts have estimated that nearly 1 billion people worldwide suffer from OSA. However, conventional therapies are limited by suboptimal efficacy and poor patient tolerance, leading to treatment abandonment rates as high as 50% among OSA patients within the first year.”

Currently, Nyxoah is collecting additional clinical data on Genio to facilitate its commercialization in Europe and to submit an application to the FDA for Genio’s approval.

(Compiled by Jiao Yanli)