Nyxoah Launches Genio System in U.S. Following FDA Approval

Nyxoah ( (NYXH) ) has provided an update.

On August 18, 2025, Nyxoah SA announced its financial and operating results for the second quarter and first half of 2025, highlighting a significant milestone with the FDA’s pre-market approval of its Genio system. This approval marks the Genio system as the first and only bilateral hypoglossal neurostimulation therapy approved in the U.S., initiating its commercial launch. The company reported a 74% year-over-year revenue growth for the second quarter, reaching €1.3 million, despite a decrease in cash reserves. The FDA approval, supported by the DREAM pivotal trial data, is expected to transform Nyxoah’s market position by offering a unique, leadless, and MRI-compatible solution for OSA patients.

The most recent analyst rating on (NYXH) stock is a Buy with a EUR18.00 price target. To see the full list of analyst forecasts on Nyxoah stock, see the NYXH Stock Forecast page.

More about Nyxoah

Nyxoah SA is a medical technology company that specializes in developing innovative treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation. The company focuses on providing differentiated solutions for OSA patients, particularly those underserved by existing therapies.

YTD Price Performance: -31.36%

Average Trading Volume: 59,441

Current Market Cap: €212.2M

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