Nyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC)

PRESS RELEASE

Nyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC)

Mont-Saint-Guibert, Belgium – 3^rd March 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announces the publication of an article presenting the first case of successful treatment of an OSA patient suffering from Complete Concentric Collapse (CCC) with Nyxoah’s unique Genio® bilateral neurostimulation solution¹.

Patients suffering from Complete Concentric Collapse (CCC) currently amount for at least 30% of the existing OSA patient population. For now, these patients are contra-indicated for existing Hypoglossal Nerve Stimulation OSA therapies. Nyxoah is currently conducting the BETTER SLEEP study, that aims to assess the effectiveness of the Genio® system bilateral hypoglossal nerve stimulation for Complete Concentric Collapse (CCC) patients and to build clinical evidence for a potential therapeutic indication expansion.

Dr. Richard Lewis, leading author of this publication and Principal Investigator of the BETTER SLEEP study commented: “This case demonstrates successful control of obstructive sleep apnea in a patient with Complete Concentric Collapse (CCC) of the redropalatal airway. Whilst the final results of the Better Sleep trial are yet to be completed, the results so far in the CCC patients indicate that the Genio® system could potentially be a treatment for OSA patients with CCC who are intolerant of CPAP.”

Olivier Taelman, Chief Executive Officer of Nyxoah, added: “I would like to thank Dr. Lewis and the Perth team for getting this manuscript published, since this is the first and promising step towards offering hypoglossal nerve stimulation to a cohort of OSA patients who are currently excluded from such therapy. We will be announcing the full results of our BETTER SLEEP study in May 2021.”

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For further information, please contact:

Nyxoah

Milena Venkova, Corporate Communications Manager

milena.venkova@nyxoah.com

+32 490 11 93 57

About Nyxoah

Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-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 the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval 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 U.S. federal law to investigational use in the United States.

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¹ Lewis R, Le J, Czank C, Raux G. Control of OSA in a patient with CCC of soft palate using bilateral hypoglossal nerve stimulation. Clin Case Rep. 2021;00:1–3 LINK

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

 

Attachment

• First positive clinical data in an OSA CCC patient