MediWound to Host Virtual Key Opinion Leader Event to Discuss EscharEx® Phase III VALUE Study in Venous Leg Ulcers and Its Commercial Opportunity on January 8, 2025
YAVNE, Israel, Dec. 17, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced it will host a virtual Key Opinion Leader (KOL) event on Wednesday, January 8, 2025, at 10:00 AM ET. The event will focus on EscharEx®, an innovative biologic drug in late-stage clinical development for chronic wound debridement, including the upcoming Phase III VALUE study in venous leg ulcers (VLUs) and EscharEx’s commercial opportunity.
The event will feature three distinguished clinical experts:
John C. Lantis II, MD | Icahn School of Medicine at Mount Sinai
Vickie R. Driver, DPM, MS, FACFAS, FAAWC | Washington State University
Robert J. Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS | Barry University School of Podiatric Medicine
Discussion Topics Include:
Compelling results to date from Phase II studies of EscharEx
The upcoming Phase III VALUE study of EscharEx in VLUs
The substantial unmet need and current treatment landscape for VLUs and diabetic foot ulcers (DFUs)
EscharEx's competitive advantages and unique commercial potential
A live question and answer session with the key opinion leaders and members of MediWound's leadership team will follow the formal presentations. To register for the event, please click here.
Speaker Bios:
John C. Lantis II, MD Dr. John C. Lantis is currently the site Chief and Professor of Surgery at Mount Sinai West Hospital, and the Icahn School of Medicine in mid-town Manhattan where he practices as a senior vascular surgeon. On January 1, 2024 he was named the Director of Advanced Wound Care, Department of surgery, Mount Sinai healthcare system. In 2023, he was named the Editor in Chief of the journal WOUNDS, a Clinical Compendium. He is the past president of the New York Vascular Surgery Society, a founding member of the American Board of Wound Medicine and Surgery, and the Vascular Study Group of New York. He is recognized as a world leader in limb salvage and lower extremity wound healing, which includes a very large breadth of knowledge regarding cellular and tissue-based therapies, negative pressure wound therapy, growth factor and stem cell therapy, and local/regional flap therapy. He has been a principal investigator on over 80 clinical trials.
Vickie R. Driver, DPM, MS, FACFAS, FAAWC Dr. Vickie R. Driver is a Professor at Washington State University School of Medicine. She is also a Fellow of the Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow of the Association for the Advancement of Wound Care. She serves as Honorary Visiting Professor at Cardiff University (UK) in the Department of Medicine and Professor-affiliate at Barry University (USA) and received the prestigious Robert A. Warriner III, MD Memorial Award. Dr. Driver currently serves and has served in multiple key leadership positions, including as past president of the Advancement of Wound Care Association, and a Board of Directors member of the Wound Healing Society and Critical Limb Ischemia Global Society. She is the Founding Chairperson for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS, and the NIH. As lead investigator, she has served on and initiated more than 70 important multi-center randomized clinical trials, as well as developed and supervised multiple research fellowship training programs. She has co-authored well over 150 publications and abstracts and was a Director at the Translational Medicine at Novartis Institute for BioMedical Research.
Robert J. Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS Dr. Robert J. Snyder is a distinguished Professor and serves as Dean and the Director of Clinical Research at Barry University. He is a Diplomat of the American Board of Podiatric Surgery, a fellow of the American College of Foot and Ankle Surgery and was the President of both the Association for the Advancement of Wound Care and the American Board of Wound Management. Additionally, he is an Honorary Senior Lecturer at The Centre of Medical Education at The University of Wales School of Medicine. Dr. Snyder has been principal investigator on more than 60 randomized-controlled trials regarding innovative wound healing therapies. He has published more than 165 peer-reviewed and trade journal articles, and currently serves on several editorial advisory boards. He has received numerous awards including the Robert A. Warriner III, MD Memorial Award for Excellence in Wound Management and the SAWC Founders Award for his work in wound management education and research. Dr. Snyder was recently inducted as a Faculty Fellow in Podiatric Medicine, Royal College of Physicians and Surgeons (Glasgow).
About EscharEx EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes, enriched with bromelain, designed for topical and easy-to-use daily applications. In three previous 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, effectively preparing the wound bed for healing. MediWound is set to initiate Phase III study for venous leg ulcers (VLUs) imminently. Preparations for a Phase II/III study targeting diabetic foot ulcers (DFUs) are underway.
About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare 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, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx®, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the current $360+ million market leader, presenting a unique opportunity for significant market growth.
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 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 EscharEx, 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 EscharEx in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of EscharEx; our expectations regarding future growth; market acceptance of EscharEx; 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 EscharEx 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.
