Image source: Shutterstock

Highlights

  • Q1 2025 revenue slightly decreased to €1.1M from €1.2M in Q1 2024
  • Cash and financial assets declined from €85.6M to €63.0M over the quarter
  • FDA final site inspection pending for potential Genio® system approval in the U.S.

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced its financial results for the first quarter of 2025, reporting revenue of €1.1 million, down from €1.2 million in the same quarter last year.

The company ended the quarter with €63.0 million in cash, cash equivalents, and financial assets, a significant reduction from €85.6 million at the end of 2024. The decrease reflects ongoing investments in regulatory processes, commercial infrastructure, and product development.

A key development for the quarter was receiving an FDA Approvable Letter for Nyxoah’s Genio® neuromodulation system, indicating the U.S. Food and Drug Administration has found the company’s premarket approval (PMA) application to be substantially complete. The letter signals that full approval is contingent upon a satisfactory on-site inspection of the company's contract manufacturing facility in the U.S.

Nyxoah has completed all FDA-requested process validations, and the final inspection is currently in progress. The same facility previously passed an FDA inspection without noted deficiencies. Pending the outcome of this review, the company anticipates that its Genio® system could receive FDA approval as early as the second quarter of 2025.

On the commercial front, Nyxoah launched Genio® 2.1, an upgraded version of its patient software, in international markets. The software update is part of the company’s broader strategy to enhance its digital offerings and improve patient engagement outside the U.S.

The company continues to prioritize FDA approval and commercial expansion. However, the cash burn rate and flat revenue growth will likely remain key concerns for investors until Genio® achieves broader market access.

With regulatory milestones in focus and cash reserves trending downward, the coming quarter may be pivotal in shaping Nyxoah’s financial trajectory and commercial prospects.