MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
Rhea-AI Summary
MediWound (Nasdaq: MDWD) has published new Phase II data analysis for EscharEx® in the treatment of venous leg ulcers (VLUs) in Advances in Wound Care journal. The study, analyzing 119 VLU patients, demonstrated a significant correlation between wound bed preparation (WBP) and wound closure.
Key findings revealed that wounds achieving WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004). Notably, wounds failing to achieve WBP had a 90% probability of not healing. Early WBP achievement (within 14 days) showed a significantly increased healing likelihood (Relative Risk = 2.4). The study validates EscharEx's potential in accelerating wound bed preparation for improved healing outcomes.
Positive
- Strong statistical significance (p = 0.0004) showing wounds with WBP are 4.1x more likely to close
- High negative predictive value of 90% validates the clinical importance of the treatment
- Early WBP achievement (14 days) showed 2.4x higher likelihood of healing
- Publication in a leading peer-reviewed journal adds credibility to findings
Negative
- Study was a post-hoc analysis, which may be considered less robust than pre-planned analyses
- Limited sample size of 119 patients may affect broader applicability of results
Insights
MediWound's EscharEx Phase II data shows wound bed preparation directly correlates with healing success, validating its clinical potential in venous leg ulcers.
The recently published post-hoc analysis of MediWound's Phase II trial provides compelling evidence supporting EscharEx's mechanism of action and clinical utility. The data reveals a critical insight about chronic wound healing: wounds that failed to achieve proper wound bed preparation (WBP) had a 90% probability of not healing at all. This remarkably high negative predictive value establishes WBP as not merely helpful but essentially prerequisite for healing.
The 4.1-fold increased likelihood of closure in wounds achieving WBP demonstrates the statistical significance of this correlation (p=0.0004). Particularly notable is the timing factor - early WBP achievement (within 14 days) was associated with a 2.4x higher healing rate. The 12-fold increased risk of wounds remaining unhealed without proper WBP (p<0.0001) further reinforces this relationship.
What makes this study particularly valuable is that it provides quantifiable evidence for what wound care specialists have long theorized - that proper debridement and granulation tissue development are rate-limiting steps in chronic wound healing. For venous leg ulcers, which affect millions globally and often remain unhealed for months or years, this data establishes clear treatment endpoints that correlate with ultimate healing success.
This validation of EscharEx's therapeutic approach strengthens its clinical positioning in the chronic wound care market, where effective debridement solutions that can accelerate the preparation phase represent a significant unmet need.
MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
Post hoc analysis published in Advances in Wound Care, provides clinical evidence supporting wound bed preparation as a critical step in the healing process
YAVNE, Israel, August 13, 2025 (GLOBE NEWSWIRE) – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of “The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial”, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs).
The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. The incidence of wound closure was compared between patients who achieved WBP by day 14 and those who did not, as well as between those who achieved WBP at any time and those who did not. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue.
Key Findings:
- Wounds that failed to achieve WBP had a
90% probability of not healing (Negative Predictive Value =90% ) - Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004)
- Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005)
- Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001)
These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx’s therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers.
Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: “While wound bed preparation has long been accepted as the conceptual foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. In other words, wounds that are not adequately prepared are highly unlikely to proceed to closure, underscoring the essential role of wound bed preparation in the healing process. Without adequate wound bed preparation, chronic wounds rarely heal.”
About EscharEx®
EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily application, EscharEx has demonstrated a favorable safety profile and effective wound bed preparation in multiple Phase II trials. The therapy has shown the ability to remove non-viable tissue, promote granulation tissue, and reduce bioburden and biofilm. A global Phase III study in venous leg ulcers (VLUs) is currently underway, with a clinical study in diabetic foot ulcers (DFUs) in preparation. EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
For more information visit www.mediwound.com and follow us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound Contacts:
Hani Luxenburg Daniel Ferry
Chief Financial Officer Managing Director
MediWound Ltd. LifeSci Advisors, LLC
ir@mediwound.com daniel@lifesciadvisors.com
Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com
+1-929-588-2008
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