Mont-Saint-Guibert, Belgium – July 18, 2022, 10:30 PM CET / 4:30 PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) has announced that its next-generation Genio® 2.1 system has been granted CE mark approval by the DEKRA Notified Body for patients across Europe. This follows the recent FDA approval for the Genio® 2.1 system to be utilized in the DREAM U.S. IDE pivotal study. The CE mark applies specifically to the external components of the Genio® system and will be accessible to all patients who have received Genio® implants.

The Genio® 2.1 is designed to enhance patient comfort and compliance through a new smartphone application and an upgraded external activation chip. This system enables patients to receive daily feedback on therapy usage and allows them to adjust stimulation amplitude within predefined limits. Additionally, physicians can fine-tune stimulation levels to ensure optimal comfort without sacrificing the effectiveness of the therapy. New embedded sensors will provide physicians with the ability to customize stimulation parameters based on the patient’s position and throughout the night.

“Genio® 2.1 exemplifies our commitment to patient-centric design and the scalability of the Genio® platform, offering features that enhance therapy customization to meet the unique needs of each patient,” stated Olivier Taelman, Nyxoah’s Chief Executive Officer. “Importantly, these advancements can be implemented without the need for surgical replacement of the implantable components. We are thrilled to launch Genio® 2.1 in Europe, reinforcing our mission to cater to the needs of OSA patients with and without Complete Concentric Collapse (CCC), while also accelerating our market share growth.”

About Nyxoah:
Nyxoah is a medical technology company dedicated to developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA). Its flagship product, the Genio® system, provides a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA, which is the most prevalent sleep disordered breathing condition linked to increased mortality and cardiovascular issues. Nyxoah envisions a future where OSA patients can experience restful nights and lead fulfilling lives.

Following the successful BLAST OSA study, Nyxoah’s Genio® system received its European CE Mark in 2019. The company has successfully completed two IPOs: one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021. Following positive results from the BETTER SLEEP study, Nyxoah obtained CE mark approval for expanding therapeutic indications to include Complete Concentric Collapse (CCC) patients, a group currently excluded from competitor therapies. Nyxoah is also conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

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