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Nyxoah Gains FDA Approval for Genio System in U.S.

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Nyxoah Gains FDA Approval for Genio System in U.S.

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An announcement from Nyxoah ( (NYXH) ) is now available.

On August 8, 2025, Nyxoah announced the FDA approval of its Genio system for treating moderate to severe OSA in the U.S., marking a significant milestone for the company. The Genio system, which utilizes a unique bilateral stimulation approach, demonstrated high efficacy in clinical trials, including the DREAM study, which showed a notable reduction in the Apnea-Hypopnea Index (AHI) across different sleeping positions. Additionally, Nyxoah reported preliminary financial results for Q2 2025, showing a 73% increase in revenue compared to the previous year, despite a rise in operating expenses. The company is also transitioning its R&D activities to the U.S. and Belgium, indicating a strategic shift in its operations.

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 is a medical technology company focused on developing and commercializing innovative solutions for treating Obstructive Sleep Apnea (OSA). Their lead product, the Genio system, offers a leadless, battery-free hypoglossal neurostimulation therapy designed to improve sleep for OSA patients. Nyxoah has successfully completed multiple studies and received regulatory approvals, including a European CE Mark and U.S. FDA approval, to expand its market presence.

YTD Price Performance: -21.79%

Average Trading Volume: 45,226

Current Market Cap: €241.8M

Learn more about NYXH stock on TipRanks’ Stock Analysis page.

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