Nyxoah SA, makers of a European Union CE-validated neurostimulator for obstructive sleep apnea (OSA) that is working on getting US Food and Drug Administration approval, has published the first case of successful treatment of an OSA patient who has complete concentric collapse (CCC) of the airway with Nyxoah’s Genio bilateral neurostimulation solution. The case report is published in journal Clinical Case Reports.
Currently, patients with complete concentric collapse are contraindicated for 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 patients and to build clinical evidence for a potential therapeutic indication expansion.
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Richard Lewis, MD, leading author of this publication and principal investigator of the BETTER SLEEP study, says in a release, “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, Nyxoah CEO, says in a release, “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.”