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Nyxoah announced Tuesday that its Genio bilateral hypoglossal nerve stimulation system was granted an FDA breakthrough device designation for the treatment of adults with moderate-to-severe obstructive sleep apnoea (OSA) and complete concentric collapse (CCC) of the soft palate.
CEO Olivier Taelman remarked that "this breakthrough designation accelerates our market authorisation process in the US and expands our total addressable market to include CCC patients currently contraindicated for hypoglossal nerve stimulation."
The designation is supported by data from the BETTER SLEEP trial, which included 42 adults with moderate-to-severe OSA who failed, refused or did not tolerate positive airway pressure treatment. The study achieved its primary safety and performance endpoints, with a significant mean reduction in Apnea Hypopnea Index (AHI) from baseline to six months post-implantation in the entire cohort, including patients with and without CCC of the soft palate.
The Genio system received the CE mark in 2019 for adults with OSA and Nyxoah is looking to expand its therapeutic indications to include patients with CCC. The company is also conducting the pivotal DREAM IDE study to secure FDA and US commercialisation approval.
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