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
- 到目前爲止,EscharEx的二期研究結果令人信服
- 即將進行的EscharEx在靜脈性潰瘍(VLU)中的三期VALUE研究
- 針對靜脈性潰瘍(VLU)和糖尿病足潰瘍(DFU)的重大未滿足需求和當前治療現狀
- EscharEx的競爭優勢和獨特的商業潛力
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.
一個與意見領袖和MediWound領導團隊成員的實時問答環節將在正式演講後進行。請註冊參與此活動, 點擊這裏.
Speaker Bios:
演講者簡歷:
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.
約翰·C·蘭蒂斯二世,醫學博士
約翰·C·蘭蒂斯博士目前是西奈山西醫院的首席醫師和外科教授,以及位於曼哈頓市中心的愛康醫學院,擔任高級血管外科醫生。2024年1月1日,他被任命爲西奈醫院醫療系統外科部的高級創傷護理主任。在2023年,他被任命爲《傷口》雜誌的主編,這是一本臨床文獻集。他曾擔任紐約血管外科協會的會長,是美國創傷醫學與外科協會的創始會員,以及紐約血管研究小組的成員。他被認爲是肢體挽救和下肢創傷癒合的世界領導者,擁有廣泛的知識,涉及細胞和基於組織的治療、負壓創傷治療、生長因子和幹細胞治療,以及局部/區域型皮瓣治療。他是80多個臨床試驗的主要研究者。
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.
維基·R·德賴弗,DPm,MS,FACFAS,AAWC
維基·R·德賴弗博士是華盛頓州立大學醫學院的教授。她還是格拉斯哥皇家外科醫師學院的會員,擔任首任創傷護理進步協會的會員。她在卡迪夫大學(英國)醫學系擔任名譽訪問教授,並在巴里大學(美國)擔任附屬教授,獲得了享有盛譽的羅伯特·A·沃里納三世醫學博士紀念獎。德賴弗博士目前在多個關鍵領導職位上任職,包括創傷護理進步協會的前會長,以及創傷癒合協會和急性肢體缺血全球協會的董事會成員。她是創傷護理合作社區的創始主席,與FDA、CMS和NIH進行重要合作。作爲首席研究員,她發起並參與了70多項重要的多中心隨機臨床試驗,並開發和監督了多個研究獎學金培訓項目。她合著了150多篇出版物和摘要,並曾擔任諾華生物醫學研究所的翻譯醫學主任。
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).
羅伯特·J·斯奈德,DPm,MBA,MSc,CWSP,FFPm RCPS
羅伯特·J·斯奈德博士是一位傑出的教授,同時擔任巴里大學的院長和臨床研究主任。他是美國足部外科委員會的外交官,也是美國足踝外科醫學院的院士,曾擔任傷口護理進步協會和美國傷口管理委員會的主席。此外,他還是威爾士大學醫學院醫學教育中心的名譽高級講師。斯奈德博士是超過60項有關創新傷口癒合治療的隨機對照試驗的主要研究者。他發表了超過165篇經過同行評審的學術期刊和貿易期刊文章,並目前擔任多個編輯顧問委員會的成員。他獲得了衆多獎項,包括羅伯特·A·沃里納三世醫學博士傷口管理卓越獎和SAWC創始人獎,以表彰他在傷口管理教育和研究方面的貢獻。斯奈德博士最近被授予格拉斯哥皇家內科醫師與外科醫師學院臨床醫學教員會員。
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.
關於EscharEx
EscharEx是一種生物活性、多模式清創療法,旨在治療慢性和其他難以癒合的傷口,目前已進入臨床開發的高級階段。它是富含溴氨酸的蛋白水解酶濃縮物,設計用於局部使用,便於日常應用。在之前的三項第二階段試驗中,EscharEx被證明是安全且耐受良好。它在清創、促進肉芽組織生成以及減少各種難癒合傷口的生物負荷和生物膜方面展現了有效性,有效爲傷口癒合準備了傷口牀。MediWound即將啓動針對靜脈性腿部潰瘍(VLUs)的第三階段研究。針對糖尿病足潰瘍(DFUs)的第二/第三階段研究的準備也在進行中。
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.
關於mediwound
MediWound有限公司(納斯達克:MDWD)是全球領先的下一代酶治療的專家,專注於非手術組織修復。公司專注於創新生物製品的開發、生產和商業化,這些生物製品增強了現有的護理標準,改善了患者體驗,同時降低了醫療成本和不必要的手術。
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的第一款藥物NexoBrid是FDA和EMA批准的罕見病生物製品,用於深部分厚度和/或全厚度熱燒傷的去痂,顯著減少了手術干預的需要。MediWound利用其專有的酶技術,正在推進EscharEx,這是一種目前正在進行III期開發的有前景的候選藥物,用於慢性傷口的清創。II期臨床試驗表明,EscharEx在當前超過3.6億美元的市場領導者面前具有明顯的優勢,爲顯著的市場增長提供了獨特的機會。
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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.
關於前瞻性聲明的警示說明
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.
這些和其他重要因素在MediWound截至2023年12月31日的20-F表格年度報告中進行了更詳細的討論,該報告已於2024年3月21日提交給證券交易委員會("SEC"),以及不時提交給SEC的6-k表格季報和其他文件。這些前瞻性聲明反映了MediWound截至本日期的當前觀點,MediWound承擔並明確聲稱不承擔任何義務更新這些前瞻性聲明,以反映其各自觀點或在本發佈日期之後發生的事件或情況的變化,除非法律要求。
MediWound Contacts: | |
Hani Luxenburg | Daniel Ferry |
Chief Financial Officer | Managing Director |
MediWound Ltd. | LifeSci Advisors, LLC |
ir@mediwound.com | daniel@lifesciadvisors.com |
Media Contact: | |
Ellie Hanson | |
FINN Partners for MediWound | |
ellie.hanson@finnpartners.com |
|
+1-929-588-2008 |
MediWound聯繫方式: | |
哈尼·盧森堡 | 丹尼爾·費裏 |
首席財務官 | 常務董事 |
MediWound有限公司 | 生命科學顧問公司 |
ir@mediwound.com | daniel@lifesciadvisors.com |
媒體聯繫人: | |
艾莉·漢森 | |
MediWound的FINN合作伙伴 | |
ellie.hanson@finnpartners.com |
|
+1-929-588-2008 |
譯文內容由第三人軟體翻譯。