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
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.
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:
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
- 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:
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
- 到目前为止,EscharEx的二期研究结果令人信服
- 即将进行的EscharEx在静脉性溃疡(VLU)中的三期VALUE研究
- 针对静脉性溃疡(VLU)和糖尿病足溃疡(DFU)的重大未满足需求和当前治疗现状
- EscharEx的竞争优势和独特的商业潜力
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.
一个与意见领袖和MediWound领导团队成员的实时问答环节将在正式演讲后进行。请注册参与此活动, 点击这里.
Speaker Bios:
演讲者简历:
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.
约翰·C·兰蒂斯二世,医学博士
约翰·C·兰蒂斯博士目前是西奈山西医院的首席医师和外科教授,以及位于曼哈顿市中心的爱康医学院,担任高级血管外科医生。2024年1月1日,他被任命为西奈医院医疗系统外科部的高级创伤护理主任。在2023年,他被任命为《伤口》杂志的主编,这是一本临床文献集。他曾担任纽约血管外科协会的会长,是美国创伤医学与外科协会的创始会员,以及纽约血管研究小组的成员。他被认为是肢体挽救和下肢创伤愈合的世界领导者,拥有广泛的知识,涉及细胞和基于组织的治疗、负压创伤治疗、生长因子和干细胞治疗,以及局部/区域型皮瓣治疗。他是80多个临床试验的主要研究者。
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.
维基·R·德赖弗,DPm,MS,FACFAS,AAWC
维基·R·德赖弗博士是华盛顿州立大学医学院的教授。她还是格拉斯哥皇家外科医师学院的会员,担任首任创伤护理进步协会的会员。她在卡迪夫大学(英国)医学系担任名誉访问教授,并在巴里大学(美国)担任附属教授,获得了享有盛誉的罗伯特·A·沃里纳三世医学博士纪念奖。德赖弗博士目前在多个关键领导职位上任职,包括创伤护理进步协会的前会长,以及创伤愈合协会和急性肢体缺血全球协会的董事会成员。她是创伤护理合作社区的创始主席,与FDA、CMS和NIH进行重要合作。作为首席研究员,她发起并参与了70多项重要的多中心随机临床试验,并开发和监督了多个研究奖学金培训项目。她合著了150多篇出版物和摘要,并曾担任诺华生物医学研究所的翻译医学主任。
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).
罗伯特·J·斯奈德,DPm,MBA,MSc,CWSP,FFPm RCPS
罗伯特·J·斯奈德博士是一位杰出的教授,同时担任巴里大学的院长和临床研究主任。他是美国足部外科委员会的外交官,也是美国足踝外科医学院的院士,曾担任伤口护理进步协会和美国伤口管理委员会的主席。此外,他还是威尔士大学医学院医学教育中心的名誉高级讲师。斯奈德博士是超过60项有关创新伤口愈合治疗的随机对照试验的主要研究者。他发表了超过165篇经过同行评审的学术期刊和贸易期刊文章,并目前担任多个编辑顾问委员会的成员。他获得了众多奖项,包括罗伯特·A·沃里纳三世医学博士伤口管理卓越奖和SAWC创始人奖,以表彰他在伤口管理教育和研究方面的贡献。斯奈德博士最近被授予格拉斯哥皇家内科医师与外科医师学院临床医学教员会员。
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.
关于EscharEx
EscharEx是一种生物活性、多模式清创疗法,旨在治疗慢性和其他难以愈合的伤口,目前已进入临床开发的高级阶段。它是富含溴氨酸的蛋白水解酶浓缩物,设计用于局部使用,便于日常应用。在之前的三项第二阶段试验中,EscharEx被证明是安全且耐受良好。它在清创、促进肉芽组织生成以及减少各种难愈合伤口的生物负荷和生物膜方面展现了有效性,有效为伤口愈合准备了伤口床。MediWound即将启动针对静脉性腿部溃疡(VLUs)的第三阶段研究。针对糖尿病足溃疡(DFUs)的第二/第三阶段研究的准备也在进行中。
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.
关于mediwound
MediWound有限公司(纳斯达克:MDWD)是全球领先的下一代酶治疗的专家,专注于非手术组织修复。公司专注于创新生物制品的开发、生产和商业化,这些生物制品增强了现有的护理标准,改善了患者体验,同时降低了医疗成本和不必要的手术。
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.
MediWound的第一款药物NexoBrid是FDA和EMA批准的罕见病生物制品,用于深部分厚度和/或全厚度热烧伤的去痂,显著减少了手术干预的需要。MediWound利用其专有的酶技术,正在推进EscharEx,这是一种目前正在进行III期开发的有前景的候选药物,用于慢性伤口的清创。II期临床试验表明,EscharEx在当前超过3.6亿美元的市场领导者面前具有明显的优势,为显著的市场增长提供了独特的机会。
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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.
关于前瞻性声明的警示说明
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.
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.
这些和其他重要因素在MediWound截至2023年12月31日的20-F表格年度报告中进行了更详细的讨论,该报告已于2024年3月21日提交给证券交易委员会("SEC"),以及不时提交给SEC的6-k表格季报和其他文件。这些前瞻性声明反映了MediWound截至本日期的当前观点,MediWound承担并明确声称不承担任何义务更新这些前瞻性声明,以反映其各自观点或在本发布日期之后发生的事件或情况的变化,除非法律要求。
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