Full Year Revenue Growth
Full year 2025 revenue increased 4% to $37.1 million (flat on a constant currency basis), representing record core product sales.
International Expansion Driving Growth
Direct sales outside Germany grew 13% to $8.6 million and distributor sales grew 11.4% to $16.5 million; together these channels accounted for ~68% of total revenue, highlighting increasing diversification.
Strong Gross Margins
Gross margin was 71% for the full year 2025 and improved to 74% in Q4 2025, driven by manufacturing efficiencies.
Progress Toward Cash Flow Breakeven
Operating loss improved 10% to $14.7 million for 2025 and adjusted EBITDA loss improved 9% to $10.5 million; company expects operating cash flow breakeven in the second half of 2026 after cost reductions and working capital normalization.
Clinical and Regulatory Momentum for DrugSorb-ATR
STAR-T randomized controlled trial published in JTCVS showing DrugSorb-ATR was safe and reduces severity of bleeding in high‑risk CABG patients; ongoing interactive discussions with FDA after an appeal confirmed no device safety concerns and narrowed remaining items for resubmission.
Product and Adoption Initiatives
PuriFi pump placements exceeded 100 units globally to expand access and enable earlier intervention; HotSwap exchange innovation launched with positive clinician feedback at ISICEM; >300,000 CytoSorb treatments delivered across 70 countries.
Reduced R&D and Improved Expense Discipline
Full year operating expenses were relatively flat at $41.2 million and included $2.5 million lower R&D spend (lower clinical and project spend) alongside targeted SG&A increases for regulatory/commercial initiatives; workforce restructuring aimed to lower ongoing cash burn.