YAVNE, Israel, Oct. 25, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the establishment of a Strategic Advisory Board (SAB). The inaugural members of the MediWound SAB represent a diverse group of experienced executives who bring a depth and breadth of strategic insight to guide the Company.
“We are honored to include this group of highly regarded executives on our strategic advisory board,” said Ofer Gonen, chief executive officer of MediWound. “We are at an important inflection point with EscharEx® moving into Phase 3 studies and NexoBrid® nearing approval and commercial launch in the U.S. The insights of our SAB members will play a key role in guiding the future of MediWound and optimizing the potential of our assets.”
The inaugural members of the MediWound SAB include:
John C. Lantis, MD, Chief of Surgery at Mount Sinai West Hospital in New York, practices as a senior vascular surgeon. He holds the academic title of Professor of Surgery at the Icahn School of Medicine. He is a world leader in limb salvage and lower extremity wound healing. To date, he has been the principal investigator on over 70 clinical trials. He directs a clinical research program in the field of lower extremity wound healing and tissue repair and published extensively. He currently sits on the editorial board of WOUNDS and is a reviewer for other journals. Dr. Lantis will provide MediWound with his medical expertise in all aspects of wound care.
Samuel Moed, Venture Partner at aMoon, Israel’s largest HealthTech VC fund. Mr. Moed has recently retired from Bristol Myers Squibb (BMS), as Senior Vice President, Corporate Strategy. He led the strategic direction of the company with close linkage to all its major businesses, functions, and geographies. His recent focus was on the $90 billion acquisition and integration of Celgene by BMS. He serves in Board and advisory roles supporting companies in the HealthTech sector. Mr. Moed with his experience as an executive in the life sciences industry will provide MediWound with his expertise in strategic development for life science innovations.
Eric Shem-Tov, Co-founder and CEO of Equashield, a leading global provider of hazardous drug compounding technologies. Recently collaborated with Nordic Capital in a deal valued at $1.3 billion. He also founded Biopharmax, a global design and construction provider of manufacturing facilities and systems for biotechnology, pharmaceutical and synthesis API manufacturers. Mr. Shem-Tov will provide MediWound with his expertise in scaling up facilities and optimizing manufacturing processes.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is to leverage our enzymatic technology platform, focusing on next-generation bioactive therapies for burn care, wound care, and tissue repair.
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at the registration-stage with the United States Food and Drug Administration (FDA). NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx is our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. EscharEx is 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 in several Phase 2 trials. A meeting with the FDA to discuss the Phase 3 pivotal study design is targeted for the fourth quarter of calendar year 2022.
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. The initial data from a Phase I/II study showed MW005 to be safe and well-tolerated, with a majority of the patients who completed the study with MW005 achieving complete histological clearance of their target lesions. The Company anticipates announcing the final data in the fourth quarter of calendar year 2022.
Committed to innovation, we are dedicated to improving standard of care and enhancing patient lives. For more information, please visit www.mediwound.com.
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 (including India and Japan); 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; risks related to our contracts with BARDA; 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 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 our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s prospectus supplement, the annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, 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.
|Boaz Gur-Lavie||Monique Kosse|
|Chief Financial Officer||Managing Director|
|MediWound Ltd.||LifeSci Advisors|