Nyxoah's Innovative Sleep Apnea Treatment: A Clinical Study Update

Nyxoah announced an update on their ongoing clinical study evaluating the safety and effectiveness of their Genio® System for treating obstructive sleep apnea (OSA) in patients with complete concentric collapse of the soft palate. The Genio® System is a device that stimulates the hypoglossal nerve bilaterally to maintain an open airway during sleep. The study aims to demonstrate the system's effectiveness in reducing OSA symptoms and may positively influence Nyxoah's stock performance.

Nyxoah S.A. (NYXH) recently announced an update on their ongoing clinical study evaluating the safety and effectiveness of their Genio® System for treating obstructive sleep apnea (OSA) in patients with complete concentric collapse of the soft palate. The Genio® System is a device designed to stimulate the hypoglossal nerve bilaterally to maintain an open airway during sleep.

The 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," aims to evaluate the system's effectiveness in reducing OSA symptoms. The intervention being tested is the Genio® 2.1 System, which includes an implantable stimulator and external components like an activation chip and disposable patch.

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. 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.

Further details about the study can be found on the ClinicalTrials portal.

References:
[1] https://www.tipranks.com/news/company-announcements/nyxoahs-innovative-approach-to-sleep-apnea-a-clinical-study-update
[2] https://www.globenewswire.com/news-release/2025/07/16/3116737/0/en/Obstructive-Sleep-Apnea-Clinical-Trial-Pipeline-Expands-as-12-Companies-Driving-Innovation-in-OSA-Therapeutics-DelveInsight.html