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

 

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

 

Mont-Saint-Guibert, Belgium – 27 November 2019 

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.

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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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