By Melane Sampson
MediWound (NASDAQ: MDWD) is advancing a proprietary enzymatic platform derived from bromelain, a proteolytic enzyme extracted from pineapple stems. The company’s non-surgical approach to necrotic tissue removal has already reshaped severe burn care and is now advancing into the significantly larger and underserved chronic wound market.
“We are a vertically integrated company with exceptional R&D, a perfect clinical execution record, a strong financial position, and our own cGMP-certified sterile manufacturing facility—a combination that allows us to control quality, scale supply globally, and advance a pipeline built on a single, validated biological platform,” Ofer Gonen, CEO of MediWound, says in an interview with BioTuesdays.
Unlike traditional surgical removal of non-viable tissue, which requires operating rooms, anesthesia, and specialized surgeons, Mr. Gonen explains that MediWound’s enzymatic therapies are applied topically, selectively removing only damaged tissue while preserving healthy skin. “The result is significantly faster wound clearance, reduced trauma, and increased healing outcomes, at a major cost savings to the healthcare system.”
At the core of the company’s technology is a controlled mixture of proteolytic enzymes enriched in bromelain. While bromelain has long been known for its biological activity, MediWound has developed a proprietary extraction, purification, and enrichment process designed to preserve and amplify its therapeutic effects from plant harvest through final pharmaceutical formulation.
“Our enzymatic mixture selectively digests necrotic tissue while sparing viable tissue with a level of precision that is difficult to achieve surgically,” Mr. Gonen contends. “This selectivity reinforces both the safety and clinical utility of our products.”
He emphasizes that MediWound’s platform has been extensively studied, with more than 150 peer-reviewed publications supporting its mechanism of action, clinical performance, and safety profile.
The company’s flagship product, NexoBrid, provides the clearest validation of its enzymatic approach. An FDA-, EMA-, and PMDA-approved orphan designated biologic for the removal of non-viable tissue in patients with deep partial- and full-thickness severe burns, NexoBrid is approved in more than 40 countries around the world, including the U.S., EU, and Japan.
“For hundreds of years, the standard of care in severe burns has been surgical removal of dead tissue,” Mr. Gonen says. “But surgery is imprecise, invasive, and inevitably removes healthy tissue along with damaged skin.”
In contrast, NexoBrid is applied topically at beside. In a single four-hour application, it removes dead tissue in the majority of patients without harming viable skin, allowing patients to progress more quickly to wound closure and recovery. Because no operating room or anesthesia is required, the therapy also reduces blood loss and potential risks associated with surgery.
Mr. Gonen highlights that clinical adoption has been rapid in markets where NexoBrid is available, consistently becoming the standard of care once introduced.
“No one wants unnecessary surgery,” he says. “Patients heal faster, outcomes are better, and healthcare systems avoid the cost and complexity of the operating room.”
While demand for NexoBrid continues to grow, manufacturing capacity has historically limited the company’s ability to fully supply approved markets. To address this, MediWound has made a significant investment in expanding its state-of-the-art, cGMP-certified sterile manufacturing facility.
This expansion is expected to increase the company’s production capacity six-fold, removing a major bottleneck to growth. Commercial supply from the expansion is anticipated mid-to-late 2026.
Mr. Gonen points out that in 2025, MediWound generated approximately $17 million in revenue. The company expects both revenue growth and gross margin expansion as manufacturing scales and fixed costs are leveraged across higher volumes.
“Once capacity is no longer a constraint, we will be able to meet the growing demand,” he says.
With NexoBrid validating MediWound’s technology in one of the most demanding clinical settings—severe burns—the company is now developing the same enzymatic platform for a much larger opportunity, which is in chronic wound care.
Its lead pipeline asset, EscharEx, is an investigational bromelain-based therapy for the debridement of chronic and hard-to-heal wounds, including venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs).
Mr. Gonen explains that while severe burns and chronic wounds differ in size and etiology, the biological requirement is the same—removal of devitalized tissue to allow healing to proceed.
“In burns we call it eschar removal and in wounds we call it debridement,” he clarifies. “It’s the same biological problem.”
Chronic wounds represent a substantial and growing burden on healthcare systems worldwide. In the U.S. alone, VLUs and DFUs account for an estimated four million wounds annually. “Chronic wounds are often painful, prone to infection, slow to heal, and expensive to treat,” Mr. Gonen says.
Current debridement options are limited and include either surgical procedures or the use of a collagenase topical ointment called Santyl, first introduced to the market in 1965. Santyl remains widely used, generating an estimated $375 million in annual U.S. sales. “Santyl typically requires weeks or months of treatment and often must be combined with surgical debridement to be effective,” Mr. Gonen points out. “There is a clear gap between surgery and this outdated enzymatic option—that’s where EscharEx may fit in.”
EscharEx uses the same underlying active pharmaceutical ingredient as NexoBrid, but at roughly half the concentration, optimized for chronic wounds that are smaller and require repeated application.
In Phase 2 clinical trials across VLUs, DFUs, and traumatic wounds, EscharEx demonstrated rapid and effective debridement, typically completing removal of non-viable tissue within approximately five days. The therapy also promoted wound bed preparation and granulation tissue formation—critical steps toward wound closure.
In a comparative Phase 2 study, 63% of patients treated with EscharEx achieved complete debridement within two weeks, compared with zero patients that were treated with Santyl.
“Importantly, the improved speed and completeness of debridement did not come at the expense of safety or tolerability. What can take four to six weeks—or longer—with Santyl can be accomplished in days with ExcharEx,” Mr. Gonen contends.
Based on these results, MediWound initiated a global Phase 3 trial in VLU and Mr. Gonen says a separate DFU study is planned.
The company estimates the addressable market for VLUs and DFUs in the U.S. alone at more than $2.5 billion, and projects peak U.S. sales of approximately $831 million for EscharEx across its first two indications—VLU and DFU.
Given its speed, ease of use, and non-surgical profile, MediWound believes EscharEx has the potential to capture share across all debridement modalities, including enzymatic and surgical approaches.
“When clinicians see a drug that can debride a wound in five days, adoption drivers are very strong,” Mr. Gonen says, citing reduction treatment duration, fewer readmissions, and improved workflow across care settings.
MediWound’s technology has attracted significant public-sector interest because of its ability to heal without surgical intervention. To date, the company has received approximately $120 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), and approximately $18 million in non-diluted funding from the U.S. Department of Defense (DoD).
“These partnerships with BARDA and the DoD reflect the potential utility of MediWound’s therapies in mass-casualty and battlefield scenarios, where operating rooms and surgical teams may not be readily available,” Mr. Gonen says.
He adds that the company also maintains strategic collaborations with leading global players in severe burn care and advanced wound management to support commercialization future development.
“As of December 2025, we reported having approximately $54 million in cash and no debt,” Mr. Gonen asserts. “We believe this provides sufficient runway to reach key inflection points without near-term financing pressure.”
Looking ahead, he highlights two milestones in 2026 that are expected to be particularly significant: the launch of NexoBrid manufactured at the expanded facility, and an interim assessment from the Phase 3 EscharEx VLU trial, which is expected to support a future Biologics License Application.
“Together, these milestones remove our two biggest constraints—manufacturing capacity and late-stage clinical risk,” Mr. Gonen says. He underscores that beyond burns and chronic wounds, MediWound sees opportunities to extend its enzymatic platform into additional indications, including post-traumatic wounds and other settings where selective tissue removal is critical. The company is also developing a room-temperature formulation of NexoBrid to support emergency and battlefield use.
“Our mission is to lead the shift toward non-surgical solutions that redefine standard of care in severe burns and chronic wounds,” Mr. Gonen concludes. “We’ve proven this approach in one of the toughest clinical environments. Now we’re scaling it.”
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