Nyxoah Poised for U.S. FDA Approval in 2024, Major Revenue Growth Expected in 2025

Belgium-based Nyxoah SA (EBR, NASDAQ: NYXH), a medical technology company focused on developing solutions for obstructive sleep apnea (OSA), is expected to receive U.S. Food and Drug Administration (FDA) approval for its Genio neurostimulator by the end of the year, marking the company’s expansion into the U.S. market. The Genio system, which provides bilateral hypoglossal nerve stimulation, is designed for adult patients with moderate to severe OSA who suffer from complete concentric collapse of the soft palate. The FDA granted the Genio system breakthrough device designation in 2021.

Based on Visible Alpha consensus, the U.S. market is expected to be a significant revenue driver for Nyxoah. Analysts project U.S. revenue to reach €15.9 million in 2025, contingent on FDA approval in 2024. By 2026, the U.S. is expected to generate 64% of the company’s total revenue. Nyxoah’s strategic entry into the U.S. follows its success in Germany, the largest OSA market outside the U.S.