Phase III VALUE Trial Progress
Enrollment ongoing in global Phase III VALUE study targeting 216 patients across ~40 U.S. and European sites; prespecified interim assessment and enrollment completion expected by year-end 2026, preserving ~90% statistical power.
Manufacturing Expansion for NexoBrid
Expanded manufacturing facility is operational and increases production capacity sixfold; commercial release from the site is subject to regulatory approvals expected in 2026, positioning the company to meet growing global demand and support stockpiling/national preparedness.
Strategic Collaborations and Industry Engagement
Multiple research collaborations with market-leading wound care companies (Coloplast/Kerecis, ConvaTec, Essity, Mölnlycke, Solventum, MiMedx and new collaboration with B. Braun for DFU Phase II) strengthen development, broaden clinical footprint, and support market access.
Clinical and Real-World Evidence Supporting NexoBrid
NexoBrid utilization across 70+ U.S. burn centers (majority of Vericel's ~90 target accounts); Israel Defense Forces data (~5,000 combat casualties) show clinical applicability in 71% of war-related injuries; prospective data show >90% reduction in embedded particles in ablation/blast injuries; 15-year military analysis reported a 50% increase in proportion of severe burns among wounded soldiers.
Strengthened Cash Position and Financing
Cash, cash equivalents and deposits of $53.6M at 12/31/2025 versus $43.6M at 12/31/2024 (≈+23%); completed $30.0M registered direct offering plus $3.5M from Series A warrant exercises, supporting runway amid continued investment.
Reaffirmed Multiyear Revenue Guidance
Company reaffirmed guidance: $24M–$26M for 2026, $32M–$35M for 2027, and $50M–$55M for 2028; guidance assumes continued support from BARDA and U.S. Department of War and potential initial EscharEx contribution in 2028.
Improved Full-Year Gross Margin
Full-year 2025 gross profit of $3.3M (19.2% margin) versus $2.6M (13.0% margin) in 2024 — gross profit increased ≈27% year-over-year with a margin improvement of +6.2 percentage points.