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Nyxoah Nears FDA Approval for Genio® System Amid Q1 2025 Results

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Nyxoah Nears FDA Approval for Genio® System Amid Q1 2025 Results

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Nyxoah ( (NYXH) ) has provided an announcement.

On May 14, 2025, Nyxoah SA announced its financial and operating results for the first quarter of 2025, highlighting a revenue of €1.1 million, a slight decrease from the previous year. The company is on track for the anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements with the final site inspection in progress. This approval is expected to enhance Nyxoah’s market positioning and provide significant opportunities for growth in the U.S. market.

The most recent analyst rating on (NYXH) stock is a Buy with a EUR27.00 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 specializing in the development of innovative treatment alternatives for Obstructive Sleep Apnea (OSA) using neuromodulation techniques. The company is focused on the Genio® system, a breakthrough device designed to address OSA, and is actively engaged in expanding its market presence internationally.

Average Trading Volume: 76,828

Current Market Cap: €187.4M

See more insights into NYXH stock on TipRanks’ Stock Analysis page.

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