Nyxoah SA

Nyxoah SA Company Overview

Nyxoah SA is a Belgium-based medical technology company founded on 15 July 2009. It focuses on the development and commercialization of minimally invasive neurostimulation therapies for obstructive sleep apnea (OSA). Nyxoah is dual-listed on Euronext Brussels and the NASDAQ Global Market under ticker “NYXH”.

Core Business and Key Technologies

Nyxoah’s flagship technology is the Genio^® system—the first bilateral, leadless, and battery-free hypoglossal neurostimulation (HGNS) device for moderate-to-severe OSA. Key proprietary features include:

• Ultra-thin (≤ 3 mm) implantable neurostimulator powered by an external patch.

• Bilateral CE-marked stimulation synchronized with breathing cycles to maintain airway patency.

• Full 1.5 T and 3 T MRI compatibility without the need for device explantation.

• Patient-friendly mobile app for therapy titration, remote monitoring, and data sharing.

Market Position and Flagship Product

Genio^® is the only CE-certified HGNS device proven effective in patients with or without complete concentric collapse (CCC), expanding eligibility to over 90% of moderate-to-severe OSA cases. Clinical and market highlights include:

• DREAM pivotal trial: 63.5% AHI response rate and 70.8% median AHI reduction; 66.6% reduction in supine position.

• ACCESS IDE trial ongoing in the U.S. for CCC patients, supported by FDA Breakthrough Device designation.

• Commercial rollout in Europe since July 2020 with more than 1,500 implants performed.

• On 11 August 2025, FDA granted PMA approval for Genio^® in the U.S., leading to a 9.4% share-price surge and the launch of a fully staffed U.S. commercial organization.

Contact Information

Address: Rue Edouard Belin 12, B-1435 Mont-Saint-Guibert, Belgium

Phone: +32 10 22 23 55

Email: info@nyxoah.com