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Benefits and safety of Genio® system implantation technique published in Laryngoscope Investigative Otolaryngology

27 th Feb, 2020

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MONT-SAINT-GUIBERT, BELGIUM

Nyxoah announces data demonstrating the benefits and safety of its Genio® system implantation technique for the treatment of Obstructive Sleep Apnea published in Laryngoscope Investigative Otolaryngology

  • Data show that the implantation procedure of the Genio® system is relatively non- invasive
  • Implantation was safe, and its therapeutic benefit demonstrated in reducing apnea and hypopnea events in a single case study

Nyxoah S.A., a healthtech company focused on the development of innovative solutions and services for sleep related disorders, today announces that data demonstrating the benefits and safety of its Genio® system implantation technique for the treatment of Obstructive Sleep Apnea (OSA) have been published in Laryngoscope Investigative Otolaryngology.

Unlike other devices for OSA that comprise a cuff electrode wrapped around the hypoglossal nerve, the Genio® system offers bilateral stimulation of the hypoglossal nerve branches, which may lead to potentially greater airway opening. This study describes the surgical implantation of the Genio® nerve stimulator, which is minimally invasive, involving just one incision in the chin area, no tunnelling, and no long leads or internal battery. Other devices require additional incision sites for implanting sensing/stimulating leads and a pulse generator. The recently completed clinical study (the BLAST OSA study) also provides evidence as to the acceptable safety profile and the therapeutic benefits of the Genio® system.

Dr. Richard Lewis, MBBS, FRACS, Head & Neck Surgeon and lead author of this publication commented: “Unlike other commercially available devices for OSA, which involve multiple incision sites, the Genio® system only requires a minimal surgical procedure, with one incision site beneath the chin. The results from the BLAST OSA study have been very encouraging, and the bilateral stimulation of the hypoglossal nerve, which is unique to the Genio® system, may provide a therapeutic advantage over unilateral stimulation. We are already well into our next, larger clinical study which is being conducted in Australia and New Zealand, and I look forward to continuing to support the Company with the development and improvement of the Genio® system for the benefit of OSA patients worldwide.”

Robert Taub, Co-Founder and Executive Chairman of Nyxoah, said: “We are pleased to announce the publication of these data demonstrating the safe implantation technique and therapeutic benefit of our Genio® system. Following the recent positive outcomes of the BLAST OSA study, on which our CE Mark registration is based, we will continue to build a strong body of evidence to continue to support the positive results seen so far.” The Genio® system is the world’s first and only battery-free, leadless and minimally invasive neurostimulator and is capable of delivering bilateral hypoglossal nerve stimulation in moderate to severe OSA patients who have not tolerated, have failed or refused Positive Airway Pressure (PAP) therapy.

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.

About Nyxoah

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.

All rights reserved © 2020 Nyxoah S.A. All content on this presentation, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design etc., are the property of Nyxoah SA. Nyxoah S.A. owns all rights with respect to any of their trademarks, service marks, logos, and copyrighted works appearing on this presentation. Patented and design protected technology. Device not for sale in U.S. The Genio® system by Nyxoah is intended to be used for patients who suffer from moderate to severe Obstructive Sleep Apnea (AHI of 15 to 65), have not tolerated, failed or refused PAP therapy and are not significantly overweight. Reviewed and approved: February 2020

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