Oral presentations include additional comparative data between EscharEx® and SANTYL®, and new analyses show strong correlation between wound bed preparation and wound healing Analyses validate the planned design and endpoints of the upcoming Phase III study YAVNE, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today that recent clinical data from EscharEx® Phase II studies will be presented throughout May 2024 at the largest, most prestigious annual meetings in the field of chronic wound care: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC). The oral presentations on EscharEx will include: Comparative data of EscharEx vs. SANTYL® that demonstrate EscharEx’s superiority over the current leading enzymatic debridement agentNew analyses from the ChronEx phase II study, showing high correlation between wound bed preparation and wound healing These data indicate that EscharEx could substantially improve wound care for patients with debilitating chronic wounds, providing significant benefits over the current standard of care. Additionally, the findings support the design and endpoints of the upcoming Phase III study, which is expected to begin in the second half of 2024. "We are delighted to present the results of additional analyses from EscharEx Phase II studies in chronic hard-to-heal wounds, including the positive comparative data with SANTYL®, the current dominant standard of care for enzymatic debridement," said Dr. Robert J. Snyder, Chief Medical Officer of MediWound. "With its robust efficacy, favorable safety profile, and multimodal mechanistic effects demonstrated in these Phase II studies, we believe that EscharEx can significantly advance wound care and has the potential to become a major player in the global wound care market." 2024 European Wound Management Association (EWMA), London, United KingdomTime:May 1, at 11:45amTitle:Comparison of bromelain-based enzymatic debridement to collagenase ointmentPresenter:Cyaandi R. Dove, DPM Time:May 3, at 8:30amTitle:VLU wound bed preparation is highly correlated with wound closurePresenter:Robert J. Snyder, DPM, MSc, MBA 2024 Wound Healing Society Conference (WHS), Orlando, FloridaTime:May 16, at 10:30amTitle:Comparison of bromelain-based enzymatic debridement to collagenase SANTYL® ointmentPresenter:Cyaandi R. Dove, DPM Time:May 16, at 10:30amTitle:VLU wound bed preparation is highly correlated with wound closure Presenter:Marissa Carter, MA, PhD 2024 Symposium on Advanced Wound Care (SAWC), Orlando, FloridaTime:May 17, at 7:30amLocation:SAWC Innovation TheaterTitle:EscharEx, an innovative multimodal enzymatic debridement agent for the treatment of chronic woundsPresenters:Vickie R. Driver, DPM, MS, FACFAS, John C. Lantis, MD, Cyaandi R. Dove, DPM, and Robert J. Snyder, DPM, will discuss the importance of wound bed preparation in wound healing, EscharEx’s mechanism of action, results from the ChronEx Phase II study including case studies showcasing the treatment experience, and the design of the upcoming Phase III study in venous leg ulcers (VLU) About EscharEx EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds. EscharEx’s mechanism of action is mediated by a mixture of multiple proteolytic enzymes that remove non-viable tissue preparing the wound bed for healing. A Phase III study in patients with VLU, is planned to start in the second half of 2024. About MediWound MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. MediWound specializes in the development, production and commercialization of solutions that seek to improve existing standards of care. The Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound’s first drug, NexoBrid®, is an FDA and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market. For more information visit www.mediwound.com and follow the Company on LinkedIn and X. About European Wound Management Association (EWMA) The EWMA is a European not-for-profit umbrella organization, linking national wound management organizations, individuals and groups with interest in wound care. EWMA was established in 1991 as a charity organization registered in the UK. Central to EWMA’s objectives is to support implementation of interdisciplinary and cost-effective wound care of high quality. EWMA works to reach its objectives by being an educational resource, organizing conferences, contributing to international projects related to wound management, actively supporting the implementation of existing knowledge within wound management and providing information on all aspects of wound management. EWMA was founded in 1991, and the association works to promote the advancement of education and research into native epidemiology, pathology, diagnosis, prevention and management of wounds of all etiologies. About Symposium on Advanced Wound Care (SAWC) The SAWC, the official bi-annual meeting site of the Wound Healing Society, is the world’s most comprehensive wound event of the year featuring scientific abstracts highlighting updates on the most critical topics in wound care. The SAWC Spring, now in its 37th year, serves as a forum to connect the entire wound care team, physicians (DO, DPM, MD), nurses, physical therapists, researchers, scientists, and dietitians, with the foremost experts in wound care to improve patient outcomes through education. About Wound Healing Society (WHS) Founded in 1989, the Wound Healing Society (WHS) is the premier scientific organization focused on wound healing. A nonprofit organization composed of clinical and basic scientists and wound care specialists, the mission of the WHS is to improve wound healing outcomes through science, professional education, and communication. The WHS provides a forum for interaction among scientists, clinicians, and other wound care practitioners, industrial representatives, and government agencies. The WHS is open to individuals who are interested in the field of wound healing and presently comprises more than 500 members in the United States and other countries. The Society’s journal, Wound Repair and Regeneration, is the leading journal in the discipline. The WHS also publishes a periodical called Advances in Wound Care, an authoritative desktop reference for all wound care professionals. 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®. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 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.
