Nyxoah Nears FDA Approval for Genio System Amid Q1 Loss

Nyxoah SA reported mixed financial results for the first quarter of 2025, with revenues declining to approximately €1.1 million from €1.2 million the previous year and an increased quarterly loss of $0.63 per share, missing analyst expectations. Despite these challenges, the company is optimistic about its FDA Premarket Approval (PMA) process for its Genio® system, having received an approvable letter confirming substantial compliance with regulatory requirements, with the final manufacturing site inspection expected soon. Nyxoah is preparing for a U.S. market launch by building a commercial team and plans to use the established CPT code 64568 for reimbursement, aiming to compete on technology benefits and pricing parity with rivals. The company also enhanced its product offering with the Genio 2.1 software upgrade, improving patient customization and comfort, and has initiated expansion into the Middle East market. Cash reserves have decreased from €85.6 million at the end of 2024 to €63 million as of March 2025, reflecting increased operating and R&D expenses. CEO Olivier Taelman expressed confidence in obtaining FDA approval potentially by the second quarter of 2025, marking a critical milestone for Nyxoah's growth strategy.