Nyxoah Stock Soars 15.63% on FDA Approval, Positive Study Results

On August 11, 2025, Nyxoah's stock surged by 15.63% in pre-market trading, marking a significant rise that has caught the attention of investors and analysts alike.

Nyxoah's Genio system, a leadless, bilateral hypoglossal nerve stimulator, has received full FDA approval for the treatment of moderate to severe obstructive sleep apnea. This approval is a major milestone for the company, as it opens up new opportunities in the U.S. market. The Genio system is designed to provide a non-invasive treatment option for patients suffering from this condition, which is a significant advancement in the field of sleep medicine.

In addition to the FDA approval, Nyxoah has also announced positive outcomes from the DREAM IDE pivotal study. This study further validates the efficacy and safety of the Genio system, providing additional confidence for both patients and healthcare providers. The company's focus on innovation and patient-centered care is evident in its continued efforts to improve the lives of those affected by obstructive sleep apnea.

Nyxoah's recent developments have positioned the company as a leader in the treatment of obstructive sleep apnea. With the FDA approval and positive study results, Nyxoah is well-positioned to expand its market presence and continue to innovate in the field of sleep medicine. The company's commitment to improving patient outcomes and its focus on cutting-edge technology make it a strong contender in the medical device industry.