Nyxoah SA (NASDAQ: NYXH)

Nyxoah SA is a medical technology company focused on developing and commercializing innovative solutions for the treatment of Obstructive Sleep Apnea, or OSA. Its lead product is the Genio system, a CE-Marked and FDA-approved hypoglossal neurostimulation therapy designed for moderate to severe OSA patients who have failed or cannot tolerate conventional positive airway pressure treatments. The system features a leadless, externally powered neurostimulator implanted via a single-incision procedure to deliver bilateral stimulation of the hypoglossal nerve, maintaining upper airway patency during sleep.

Nyxoah SA generates revenue primarily through the sale of the Genio system, which includes the implantable stimulator, external activation chip, disposable patch, charging unit, and related accessories. The company sells its products to hospitals, sleep centers, and healthcare providers where ear, nose, and throat specialists, sleep physicians, and general practitioners diagnose and treat OSA patients. Revenue began in Europe in July 2020 following CE Mark approval and expanded to the United States in September 2025 after receiving FDA approval for a subset of adult patients with moderate to severe OSA.

The company operates through the following segments:

• Genio system: This segment encompasses the development, manufacturing, and commercialization of the Genio hypoglossal neurostimulation system for the treatment of moderate to severe Obstructive Sleep Apnea. The system includes the Genio implantable stimulator, the external activation chip, the disposable patch, the charging unit, the external stimulator, the sleep lab application, and the smartphone application. The Genio 2.1 system, an updated version featuring Bluetooth capability and enhanced patient feedback through a smartphone application, is also part of this segment.

Nyxoah SA holds a differentiated position in the OSA treatment market due to its leadless, externally powered design and bilateral stimulation capability, which distinguishes it from competing hypoglossal nerve stimulation devices that typically require implantable batteries and multiple leads. The Genio system is the only neurostimulation therapy with MR Conditional labeling for full-body MRI scans at both 1.5T and 3T under both CE Mark and FDA approvals, providing a significant advantage over competitors whose devices are either MR Unsafe or only conditionally safe at 1.5T. The company’s technology addresses a substantial unmet need, as an estimated 35% of moderate to severe OSA patients in the United States suffer from complete concentric collapse, a condition that contraindicates other available HGNS therapies but is treatable with the Genio system.

Nyxoah SA serves hospitals, sleep centers, and healthcare providers where physicians specializing in otolaryngology, sleep medicine, and general practice diagnose and treat patients with moderate to severe Obstructive Sleep Apnea. The company targets high-volume ENT and sleep centers to establish long-term partnerships and develop Centers of Excellence for the Genio system. Specific customer accounts include activated accounts in the United States where surgeons have been trained and the system has been approved through value analysis committee processes, as well as implant centers in Germany, Switzerland, Spain, Finland, Austria, England, the United Arab Emirates, and the Netherlands.