MediWound Advances EscharEx Phase III Trial and Expands Manufacturing Capacity Ahead of Key 2026 Milestones
核心洞察
MediWound's EscharEx VALUE Phase III trial for venous leg ulcers (搜索) continues enrollment targeting 216 patients, with interim assessment and completion expected by year-end 2026.
The company plans to expand EscharEx development into diabetic foot ulcers (搜索) and pressure ulcers (搜索) in 2026 following positive regulatory feedback from FDA and EMA.
NexoBrid manufacturing facility expansion is now fully operational with sixfold increased production capacity, positioning the company for anticipated regulatory approvals in 2026.
MediWound Ltd. (Nasdaq: MDWD) announced significant progress across its enzymatic therapeutics pipeline and manufacturing operations, positioning the company for key regulatory and commercial milestones in 2026. The Israeli biotechnology company provided updates on its late-stage wound care programs ahead of the J.P. Morgan Healthcare Conference.
EscharEx Phase III Program Advances Toward Key Milestones
The company's VALUE global Phase III study of EscharEx in venous leg ulcers (搜索) continues enrollment, targeting 216 patients across approximately 40 sites in the U.S. and Europe. According to CEO Ofer Gonen, "the majority of which are active and recruiting." The pre-specified interim sample-size assessment and enrollment completion are expected by year-end 2026.
Following constructive regulatory feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), MediWound plans to initiate a Phase II study of EscharEx in diabetic foot ulcers (搜索) in the second half of 2026. Additionally, a prospective, single-arm investigator-initiated trial to evaluate the safety and efficacy of EscharEx in pressure ulcers (搜索) is planned to initiate in mid-2026.
The EscharEx program has garnered significant industry support through collaborations with leading global wound care companies, including Coloplast, Convatec (搜索), Essity (搜索), Mölnlycke (搜索), Solventum (搜索), and MiMedx, reflecting strong industry validation of the program.
Manufacturing Expansion Completed
The expanded NexoBrid manufacturing facility is now fully operational, increasing production capacity sixfold to support growing global demand. Market availability remains subject to completion of regulatory reviews and approvals, which are expected in 2026.
Following the resolution of the recent U.S. government shutdown, MediWound believes that discussions between Vericel and the Biomedical Advanced Research and Development Authority (BARDA (搜索)) regarding a potential multi-year program may progress toward completion during the first quarter of 2026. If completed, the program would include stockpiling, development of a room-temperature-stable formulation of NexoBrid, and evaluation of an enzymatic debridement product for trauma, blast-injury, and friction-burn indications.
Strong Financial Position Supports Growth Strategy
MediWound reported revenue of $17 million for the full year 2025, with cash, cash equivalents, and deposits totaling $54 million as of December 31, 2025, with no debt. The company updated its revenue guidance, projecting $24-26 million in 2026, $32-35 million in 2027, and $50-55 million in 2028. All guidance periods assume continued support from BARDA (搜索) and the U.S. Department of Defense, with the 2028 outlook also assuming a potential initial contribution related to EscharEx, subject to regulatory approval.
"Over the past year, we advanced our Phase III VALUE trial toward key milestones, positioned the EscharEx program for expansion into additional chronic wound indications, strengthened our balance sheet, and completed the expansion of our NexoBrid manufacturing facility," said Gonen. "While U.S. government shutdown–related delays impacted revenue recognition in our fourth quarter results, and certain activities are still pending, we believe these effects are timing-related, and that we now have the key elements in place to continue executing our strategy."
Market Context and Therapeutic Potential
MediWound's FDA-approved biologic NexoBrid is indicated for the enzymatic removal of eschar in thermal burns (搜索) and is marketed in the United States, European Union, Japan, and additional international markets. EscharEx, the company's late-stage pipeline product, is an investigational therapy for the debridement of chronic wounds (搜索), with potential to become a new standard of care in wound management.
The wound care market is undergoing transformation as Medicare reimbursement regimes for cellular and tissue-based products are being restructured, with policymakers pushing toward more standardized, outcomes-focused utilization. This shift is creating opportunities for products with rigorous clinical data and traditional regulatory pathways.