Nyxoah

The company’s flagship product, the Genio® system, is a minimally invasive hypoglossal nerve stimulation (HGNS) therapy. It is designed for patients with moderate to severe OSA who have not been able to use or have failed traditional CPAP therapy. The system consists of a small, battery-free, and leadless neurostimulator that is implanted under the chin during a single-incision procedure. This implant delivers bilateral stimulation to the hypoglossal nerve, which controls tongue movement, to keep the upper airway open during sleep. Power and control for the implant are managed externally through a wearable activation chip that the patient applies under their chin at night, which can be connected to a smartphone app for tracking and adjustments.

Nyxoah has achieved significant regulatory milestones. The Genio® system received its European CE Mark in 2019, allowing for commercialization in Europe. In October 2021, it gained an expanded CE Mark to treat patients with Complete Concentric Collapse (CCC), a condition for which competitor therapies are often contraindicated. A major achievement occurred in August 2025, when the company received FDA approval to market the Genio system in the United States, based on positive results from its DREAM pivotal trial. The company completed two successful IPOs, first on Euronext Brussels in September 2020 and subsequently on NASDAQ in July 2021, to fund its clinical development and commercial expansion.