MediWound (NASDAQ:MDWD) CEO Ofer Gonen provided an update on the company’s commercial burn franchise, late-stage chronic wound program, manufacturing expansion plans, and government-related efforts during Oppenheimer’s Annual Healthcare Conference.
Company overview: commercial burns product and late-stage chronic wound candidate
Gonen described MediWound as a late-stage biologics company with an FDA-approved product that is generating revenue and is profitable, alongside a Phase III asset aimed at a larger market opportunity. He said the company’s enzymatic technology has been validated across 14 clinical trials and has received approvals from both the FDA and the European Medicines Agency (EMA).
The company’s second program, EscharEx, is in Phase III development for chronic wounds. Gonen said EscharEx uses the same active pharmaceutical ingredient as NexoBrid but at roughly half the concentration, with a goal of acting in days rather than weeks or months compared with current standards of care. He estimated the addressable U.S. debridement market at approximately $2.5 billion, and said the chronic wound opportunity is materially larger than burns.
Platform and partnerships
Gonen said MediWound’s core platform is a proprietary enzymatic biologic based on a carefully controlled mixture of proteolytic enzymes derived from pineapple stem. He characterized the approach as a rapid, predictable, non-surgical method designed to selectively remove devitalized tissue while preserving viable tissue.
He also highlighted global partnerships and research collaborations with wound care companies, framing them as validation of MediWound’s science and commercial relevance. In discussing the EscharEx Phase III program, he referenced research collaboration agreements with Solventum, Smith+Nephew (SCT), Mölnlycke, and MiMedx.
Key catalysts: Phase III interim readout and manufacturing approvals
Gonen outlined several upcoming milestones. For EscharEx, he said an interim Phase III readout is expected by year-end 2026 (later described as late 2026). He said the interim analysis is designed to provide a clear signal regarding study success, and that a positive outcome would position the company for a biologics license application (BLA) submission thereafter. He also said MediWound is preparing for additional chronic wound studies aimed at label expansion, including diabetic foot ulcers (DFU) and pressure ulcers.
The Phase III venous leg ulcer (VLU) study includes 216 patients across roughly 40 sites in the U.S. and Europe, with two co-primary endpoints: complete debridement and facilitation of wound closure. An interim analysis is planned after approximately 65% of patients finish enrollment.
During Q&A, Gonen said he was not concerned about the debridement endpoint, describing the effect as strong and consistently observed in prior studies. He said the company is more focused on the wound-closure-related endpoint and does not anticipate an accelerated registration timeline based solely on early debridement results. He also said the interim analysis is intended to assess whether the trial sample size should be adjusted to maintain power, noting that the current plan targets about 85% power and the company would like to maintain 90% after the interim assessment.
On the manufacturing side, Gonen said MediWound has expanded its manufacturing facility and that it is operational, with the company manufacturing NexoBrid into inventory. However, he said regulatory requirements—including stability data at three and six months—must be completed before requesting inspections. He said the company expects that after mid-2026 it will be able to call for an initial agency inspection from the EMA, followed by the FDA. Gonen added that approval from the new facility is expected around mid-2026 and is anticipated to remove current supply constraints and support global demand growth.
Government support and BARDA-related timeline
Gonen said the U.S. government has recognized the importance of non-surgical burn treatment capability for mass casualty and battlefield settings, which has translated into $140 million in non-dilutive funding. He also said the company is working to expand efforts into additional indications related to battlefield and blast injuries.
In response to questions about BARDA, Gonen said the company previously stated it expects the BARDA agreement to be concluded in Q1 2026. He said the contract is expected to be between BARDA and Vericel and would include three components:
- Stockpiling
- Development of a room-temperature stable formulation to support military use
- Development related to blast injuries
He discussed recent experience in Israel and said NexoBrid has been helpful for treating soldiers, including in blast-related injuries, and described it as becoming a standard first treatment in that setting. Separately, he referenced a recent incident in Switzerland in which dozens of patients were treated with NexoBrid and said it did not impact revenue because available inventory was used. He also stated that inventory in Europe was at zero at the time, at least for the next month or two.
Financial position and outlook comments
Gonen said MediWound has $54 million in cash and no debt, and noted that the company raised $30 million in the prior quarter. He said U.S. government collaboration funds a significant portion of operations and that the balance sheet supports execution without near-term financing pressure.
Looking ahead, he said NexoBrid revenue growth from 2026 to 2028 is expected to be driven by expanded manufacturing capacity, broader geographic penetration, and additional government contracts, with facility expansion expected to be completed in 2026. For EscharEx, he said that subject to successful Phase III results and regulatory progress, the company anticipates the potential for initial revenue as early as 2028. He also cited market research work (Alira, verified by L.E.K.) suggesting enzymatic debridement usage could increase with a product profile like EscharEx, and said MediWound estimates peak sales of approximately $831 million across VLU and DFU indications if Phase III is successful.
About MediWound (NASDAQ:MDWD)
MediWound Ltd. (NASDAQ: MDWD) is a biopharmaceutical company headquartered in Yavne, Israel, specializing in the development and commercialization of innovative enzymatic therapies for burn and wound management. Since its establishment, the company has focused on advancing proteolytic enzyme technology to address critical needs in debridement and tissue repair. MediWound operates research and development facilities in Israel and maintains commercial offices in the United States to support its global market presence.
The company’s lead product, NexoBrid®, is an enzyme-based debriding agent designed to selectively remove burn eschar without harming viable tissue.
