Nyxoah Sa ((NYXH)) announced an update on their ongoing clinical study.
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Nyxoah S.A. is conducting a multicenter study titled ‘A Multicenter Study to Assess the Safety and Effectiveness of the Genio® Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Subjects With Complete Concentric Collapse of the Soft Palate.’ The study aims to evaluate the safety and effectiveness of the Genio® System in treating obstructive sleep apnea (OSA) in patients with complete concentric collapse (CCC) of the soft palate, a condition that significantly impacts sleep quality and overall health.
The intervention being tested is the Genio® 2.1 System, a device designed to stimulate the hypoglossal nerve bilaterally to maintain an open airway during sleep. This system includes an implantable stimulator and external components like an activation chip and disposable patch, offering a less invasive alternative to traditional surgical options.
The study follows an interventional design with a single-group model and no masking, focusing primarily on treatment. Participants receive the Genio® System as the sole intervention, aiming to demonstrate its effectiveness in reducing OSA symptoms.
The study began on December 28, 2022, with recruitment currently ongoing. The primary completion and estimated study completion dates have not been specified, but the last update was submitted on July 17, 2025, indicating active progress.
This clinical update could positively influence Nyxoah’s stock performance by showcasing innovation in OSA treatment, potentially increasing investor confidence. The Genio® System’s unique approach may set Nyxoah apart from competitors in the sleep apnea device market.
The study is ongoing, with further details available on the ClinicalTrials portal.