Nyxoah SA

Nyxoah SA is a medical technology company that develops and commercializes solutions for Obstructive Sleep Apnea (OSA). The company's primary product is the Genio system, a hypoglossal neurostimulation (HGNS) therapy designed for moderate to severe OSA. This system is implanted through a single-incision procedure and is CE-Marked and FDA approved. OSA is a common sleep-disordered breathing condition linked to increased mortality risk and conditions such as cardiovascular diseases, depression, and stroke. The Genio system is a HGNS device that treats OSA by providing bilateral stimulation to maintain upper airway patency, reducing obstructive breathing events during sleep. Nyxoah SA began generating revenue from Genio system sales in Europe in July 2020. On August 8, 2025, the FDA approved the Genio system for adult patients with moderate to severe OSA, specifically those with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Sales of the Genio system in the U.S. commenced in September 2025. Approximately 425 million people globally between the ages of 30 and 69 suffer from moderate to severe OSA. In Nyxoah SA's initial target markets in Europe, an estimated 23.8 million individuals have moderate to severe OSA.