Nyxoah Submits PMA Final Module for OSA Solution Genio to US FDA

On July 1, 2024, Nyxoah SA NYXH, a pioneer in medical technology specializing in the treatment of Obstructive Sleep Apnea (OSA), announced a significant milestone in its endeavors to expand its reach in the medical device market. Headquartered in Mont-Saint-Guibert, Belgium, the company confirmed the completion and submission of the fourth and final module of its Pre-Market Approval (PMA) application for its flagship product, the Genio system, to the U.S. Food and Drug Administration (FDA).

Advancing OSA Treatment Options

The Genio system, designed by Nyxoah, represents a breakthrough in the treatment of OSA. It is a next-generation, minimally invasive solution that offers an alternative to the prevalent Continuous Positive Airway Pressure (CPAP) therapy. With the submission of the final PMA module, Nyxoah moves closer to potentially offering this innovative therapy to millions suffering from OSA in the United States.

Progression Through Regulatory Milestones

Completing the PMA process is a regulatory requirement for medical devices that are considered to possess significant risk, ensuring that they are safe and effective for public use. By submitting the final module of the PMA, Nyxoah has achieved a pivotal step in demonstrating the Genio system’s compliance with stringent FDA standards.

Implications for NYXH Investors

This advancement in the company’s PMA application could signify promising developments for shareholders and potential investors of NYXH. The approval of Genio in the U.S. market is expected to have a positive impact on the company’s growth, potentially leading to an increase in market share and revenue streams.

Nyxoah, FDA, OSA