Nyxoah Reports EUR 4.5M Q4 Revenue, EUR 83.5M Operating Loss
Nyxoah generated EUR 4.5 million in Q4 2025 and EUR 11 million in 2025 revenue following U.S. FDA approval and reimbursement for Genio in August 2025. Operating loss widened to EUR 83.5 million with quarterly cash burn of EUR 20 million and a year-end cash balance of EUR 48 million.
1. U.S. Launch and Revenue Growth
Nyxoah secured FDA approval for Genio in August 2025 and began U.S. implants and sales in September, training 145 surgeons across 125 high-volume accounts. These efforts drove €4.5 million in Q4 revenue and €11 million in total revenue for 2025.
2. Operating Loss and Cash Position
Full-year 2025 operating loss widened to €83.5 million from €58.8 million in 2024, reflecting commercialization costs. The company is burning approximately €20 million per quarter and held €48 million in cash at December 31, 2025.
3. Reimbursement and Regulatory Updates
Genio obtained reimbursement from Medicare and commercial payers, supporting early revenue generation. Nyxoah submitted 120 VAC approval requests, with 57 approved by quarter end and the remainder expected in Q1, while new interim CMS C-codes are not foreseen to hinder adoption.
4. Outlook and Competitor Landscape
Nyxoah expanded its sales force by 15 reps to cover 200 of the top 400 accounts by Q2. ACCCESS study 12-month data are expected by June with PMA supplement filing in early 2027, and competition from entrants like LivaNova could pressure market share.