MediWound Hosting Analyst Day Webinar on EscharEx – Enzymatic Debridement Agent for Chronic Wounds
MediWound Ltd. (Nasdaq: MDWD) announced an upcoming analyst day webinar on March 30, 2021, to highlight EscharEx, its enzymatic agent for chronic wound debridement. Esteemed experts will discuss U.S. chronic wound care practices and EscharEx's potential impact. The product showed promising results in Phase 2 studies, demonstrating safety and a higher incidence of complete debridement compared to hydrogel vehicles. The company’s existing product, NexoBrid, is under FDA evaluation, with a decision expected by June 29, 2021.
- EscharEx demonstrated significantly higher complete debridement rates in Phase 2 studies compared to hydrogel vehicles.
- Prominent KOLs will highlight EscharEx's potential to transform chronic wound care during the upcoming webinar.
- EscharEx remains an investigational product pending further regulatory approvals.
- The upcoming FDA decision on NexoBrid could impact financial expectations.
Webinar To Be Held on Tuesday, March 30th at 10am Eastern Time
YAVNE, Israel, March 24, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that it will host an analyst day webinar on EscharEx®, MediWound’s enzymatic debridement agent for chronic wounds, on Tuesday, March 30, 2021 at 10am Eastern Time.
The webinar will feature presentations by key opinion leaders (KOLs) Robert S. Kirsner, M.D., Ph.D., University of Miami; Adam J. Singer, M.D., Stony Brook University; and Robert J. Snyder, D.P.M., M.Sc., Barry University. The KOLs will discuss the current U.S. chronic wound debridement practices and how EscharEx, upon approval, has the potential to change the current standard of practice and care of chronic wounds, recent in vivo head-to-head comparator study results and the biofilm opportunity. Additionally, Ilina Sen, Life Sciences Sr. Director, Huron Consulting Group, will discuss the U.S. market research insight. Drs. Kirsner, Singer, and Snyder, and Ms. Sen will be available for a Q&A session following their formal presentations. Sharon Malka, MediWound's Chief Executive Officer, will provide a corporate update and an overview of the EscharEx development program.
EscharEx is MediWound's next-generation bioactive topical therapeutic under development, for debridement of chronic and hard to heal wounds. EscharEx active ingredient (API) is a concentrate of proteolytic enzymes enriched in bromelain. In two Phase 2 studies, EscharEx was well-tolerated and showed significantly higher incidence of complete debridement of various chronic wounds and other hard-to-heal wounds compared with hydrogel vehicle within a few daily applications as well as comparable safety profile. EscharEx is an investigational product, currently under investigation in a U.S. phase 2 adaptive design study.
To register for the webinar, please click here.
Dr. Kirsner is Chairman and the endowed Harvey Blank Professor in the Dr. Phillip Frost Dermatology in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine. He is Chief of Dermatology at the University of Miami Hospital and Clinics and Jackson Memorial Hospital and directs the University of Miami Hospital Wound Center. Dr. Kirsner received his undergraduate degree from Texas A&M University, his medical degree from the University of Miami and a PhD in epidemiology from the University of Miami, after he completed his clinical training. His clinical training included internal medicine, a clinical and research fellowship in wound healing and dermatology at the University of Miami. His research interests include Wound Healing and Skin Cancer Epidemiology. Dr. Kirsner serves as academic editor of the journal Wound Repair and Regeneration and is on the editorial boards for a number of journals in dermatology and wound healing. He also serves in national leadership positions in both Wound Healing and Dermatology, including currently serving on the American Academy of Dermatology Board of Directors and the Wound Healing Society Board of Directors. In addition to career development awards, foundation, industry sponsored funding and CDC funding, he currently leads or is part of a number of NIH funded grants. Independent of books, book chapters and abstracts, he has published over 550 articles.
Dr. Adam Singer is a Professor of Emergency Medicine and Vice Chairman for Research in the Department of Emergency Medicine at Stony Brook University. Dr. Singer is a world renown expert in wound care. He has extensive preclinical and clinical experience in burn and wound care. He has over 400 publications, many in high impact journals such as the New England Journal of Medicine and JAMA, including a recent review article on lower extremity ulcers in the NEJM. He has received millions of dollars in extramural funding from the NIH, DOD, BARDA and industry. He is on the editorial board of multiple journals and is the Editor-in-Chief of Clinical and Experimental Emergency Medicine. He has considerable experience with both NexoBrid and EscharEx in both humans and animal models. His preclinical data in the porcine model helped support the EMA approval of NexoBrid and he has studied the use of EscharEx in several animal models. He has been a PI for all studies of bromelain-based enzymatic debridement of burns and ulcers in the US. He has also served on several national and international organizations and committees related to wound care.
Dr. Robert Snyder is Professor and Director of Clinical Research and Fellowship Director in Wound Care and Research at Barry University School of Podiatric Medicine. He is certified in foot and ankle surgery by the American Board of Podiatric Surgery and is also a board certified wound specialist. Dr Snyder is past-president of the Association for the Advancement of Wound Care and past-president of the American Board of Wound Management, the certifying body for Wound Care Specialists. In addition to his doctorate, he holds an MSc in Wound Healing and Tissue Science from Cardiff University School of Medicine. His expertise at Cardiff, Wales, was further acknowledged by appointment as Honorary Senior Lecturer. To constantly expand his knowledge and stay current in all aspects of healthcare, he has completed an MBA in Health Management. Dr. Snyder is a key opinion leader and sought after speaker, lecturing extensively throughout the United States and abroad. He has been recognized with many awards for his contribution to the profession. Dr. Snyder has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care. He serves as Associate Editor for JAPMA and is on the editorial advisory boards of Wound Management & Prevention, Wounds and Podiatry Management. He is also a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 50 randomized controlled trials for innovative wound healing modalities and therapies. In 2018, Dr. Snyder was inducted as a Faculty Fellow of the Royal College of Physicians & Surgeons (Glasgow).
Ilina Sen brings 15 years of experience in life sciences strategy consulting. Ms. Sen guides leadership teams through research and development (R&D) portfolio planning, licensing, merger and acquisition opportunity identification, prioritization and valuation, and commercial and market access strategies for products throughout their life cycle. Her experience spans across therapeutic areas, with a focus in oncology, immune/inflammatory disorders, renal disorder, cardiovascular diseases and rare diseases. She has served a range of organizations, including top global biopharmaceutical companies, smaller biotech companies, and diagnostic firms.
Prior to joining Huron, Ms. Sen worked as a life sciences strategy senior consultant at Frankel Group for eight years. She has also worked as a consultant at Quintiles Transnational in its strategic research services group. She began her career as a research associate at the National Cancer Institute. Ms. Sen received a M.S. in Biotechnology with a concentration in Regulatory Affairs from Johns Hopkins University and a B.S. in Biology with a minor in Biomedical Engineering from Carnegie Mellon University.
About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.
NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx®, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.
MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
MediWound caution 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, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment and the completion of enrollment, the time of commencing the pharmacological study and the results , the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid and 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, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021, 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.
| Contacts: Boaz Gur-Lavie Chief Financial Officer MediWound Ltd. ir@mediwound.com | Jeremy Feffer Managing Director LifeSci Advisors 212-915-2568 jeremy@lifesciadvisors.com |
FAQ
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