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 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.
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® 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 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® system, initiating European market development activities and working toward gaining approval by the US Food and Drug Administration (FDA).
About Obstructive Sleep Apnea (OSA) and the Genio® system
OSA is the world’s most common sleep disordered breathing condition, affecting almost one billion people globally1. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or totally (apnea) blocked, limiting the amount of air that reaches the lungs. OSA is a chronic condition that is associated with increased mortality risk and comorbidities, including cardiovascular diseases, type 2 diabetes, obesity, depression and stroke. The current standard of care consists of Continuous Positive Airway Pressure (CPAP) therapy, a treatment whereby air is pushed into the upper airway to keep it open.
The Genio® system is the world’s first and only, battery-free, leadless and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep for certain people with OSA by bilateral stimulation of the hypoglossal nerve.
Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services for sleep disordered breathing conditions. Nyxoah’s lead solution is the Genio® system, a validated, user-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk2 and comorbidities including cardiovascular diseases, depression and stroke.
Following successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in March 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.
For more information, please visit www.nyxoah.com.
Caution – CE marked since 2019. Investigational device in the United States. Limited by United States federal law to investigational use.
1.Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis. Lancet Respir Med 2019 Published Online July 9, 2019 http://dx.doi.org/10.1016/S2213-2600(19)30198-5
2 Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.