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MediWound Announces €16.25 Million Funding From the European Innovation Council Accelerator Program

MediWound Announces €16.25 Million Funding From the European Innovation Council Accelerator Program

MediWound宣佈從歐洲創新委員會加速器計劃獲得1625萬歐元的資金。
Mediwound ·  07/16 12:00

Funds to be used for clinical development of EscharEx to treat diabetic foot ulcers (DFUs)

這些資金將用於臨床開發EscharEx以治療糖尿病足潰瘍(DFUs)

Award advances MediWound's DFU program and its future revenues four years ahead of original schedule

該獎項使得MediWound的DFU項目及其未來的收入提前了四年。

YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. The funding will significantly advance the Company's EscharEx development program for patients with diabetic foot ulcers (DFUs). Pending FDA and EMA approval, the funding will enable the Company to expedite the market introduction of this innovative biologic by four years, well ahead of MediWound's original schedule.

以色列亞文+國(YAVNE)2024 年 7 月 16 日/美通社——下一代酶促組織修復治療方案全球領先廠商MediWound Ltd.(納斯達克代碼:MDWD)宣佈其在加速器計劃中獲得歐洲創新委員會(European Innovation Council,EIC)1,625 萬歐元混合資金的資助。如獲得 FDA 和 EMA 批准,該資金將使公司能夠提前四年推出這款革新性的生物製品,大大加速EscharEx用於治療糖尿病足潰瘍(DFUs)的市場推廣,領先於MediWound的原定計劃。歐洲創新委員會(EIC)是一家向支持具有革命性的創新產品提供補助和股權投資的組織。除了財務支持外,選擇的項目也將從一些商業加速服務中受益,這些服務可讓他們接觸全球專家、企業、投資者和生態系統參與者。資金包括 250 萬元歐元的補助和一個投資,具體條款將在公司和 EIC 之間最終敲定。“我們爲獲得這一備受讚譽且極具競爭力的計劃感到榮幸,” MediWound 的首席執行官 Ofer Gonen 表示:“EIC 的支持表明了 EscharEx 對患者(尤其是那些面臨DFUs的嚴峻挑戰的患者)具有深刻的影響潛力。這種資金將使MediWound能夠並行開發 EscharEx 作爲對待靜脈性足潰瘍(VLUs)的先進計劃,大大增加了整體市場。”

The EIC Accelerator offers grants and equity investments to support innovative, game-changing products. In addition to financial support, selected projects benefit from a range of business acceleration services that provide access to global experts, businesses, investors and ecosystem players. The funding package includes a €2.5 million grant and an investment, with terms to be finalized between the Company and the EIC.

DFU 患者中有70%需要去污劑,EscharEx 面對着多達3400萬(美國和歐洲)有足潰瘍風險的糖尿病患者龐大市場。 如果得不到適當的治療,DFU 可導致嚴重的併發症,包括截肢、感染和死亡。加快這一項目將對這些未受服務人口中數百萬患者未來的足潰瘍治療產生革命性影響。

"We are honored to be selected for this prestigious and highly competitive program," stated Ofer Gonen, Chief Executive Officer of MediWound. "The EIC's support recognizes EscharEx's potential to profoundly impact patients, especially those living with the significant challenges of DFUs. This funding will enable MediWound to develop EscharEx for DFU in parallel with our advanced program for treating venous leg ulcers (VLUs), substantially increasing the overall market."

EscharEx是一種生物活性、多模式去污療法,用於治療慢性和其他難以治癒的傷口,目前處於臨床開發的前期階段。它是富含溴酶的蛋白水解酶濃縮物,用於易於使用的局部應用。在多項二期試驗中,EscharEx已被證明是安全且耐受的。它在治療不同難以治癒傷口的去污、促進新生組織和減少活菌量和生物菌膜方面展示了療效,有效地爲癒合做好了鋪墊。MediWound準備在2024下半年開始進行靜脈性足潰瘍(VLUs)的三期研究,以及在2025下半年開始進行鍼對糖尿病足潰瘍(DFUs)的二/三期研究。

With 70% of DFU patients requiring debridement, EscharEx addresses a staggering market of up to 34 million diabetic patients (US and Europe) who are at risk of developing a DFU in their lifetime. If not properly treated, DFUs can lead to serious complications including amputations, infections and death. Accelerating this program will have a revolutionary impact on the future DFU treatment for the millions of patients in this underserved population.

MediWound需提醒您,本新聞稿包含對我們預計、相信或預期將會或可能發生的未來活動、事件或發展的除歷史事實外的所有陳述均爲前瞻性陳述。儘管我們認爲本新聞稿中所包含的前瞻性陳述有合理依據,但它們基於我們對未來影響我們的事件的當前期望,並受到風險、假設、不確定性和因素的影響,這些風險、假設、不確定性和因素均難以預測,其中很多超出了我們的控制範圍。本新聞稿中的前瞻性陳述經常通過使用諸如“預計”、“打算”、“估計”、“計劃”、“期望”、“繼續”、“相信”、“指導”、“前途”、“目標”等類似的詞語或短語、或使用“將會”、“將”、“應該”、“可能”或類似表達方式或條件動詞來表述,但並非總是如此。

For more information about the EIC Accelerator, visit .

具體來說,本新聞稿涉及對 EIC 資助、達成與EIC的協議之可能性、EIC 資助預期金額、EscharEx 包括 DFU 程序的預期進展、開發、時間表和商業潛力的前瞻性陳述。我們無法保證能夠獲得完整的資助金額,與 EIC 達成協議,啓動或完成 EscharEx 適用於DFU的開發和/或 EscharEx 能獲得DFU適應症批准。會影響結果與現狀差異顯著因數,其中包括未能達成贈款協議和/或與公司和 EIC 達成投資協議、歐洲或國際間的市場和其他條件、未知、漫長、昂貴的產品開發過程所固有的不確定性、產品和產品候選品研究和開發計劃的時間和進行、當前和未來在行的臨床試驗進展和結果以及我們的研究和開發項目、FDA、EMA或任何其他監管當局的審批提交的批准情況、我們在美國或其他市場上獲得產品的營銷批准、我們產品和產品的臨床效用、潛在優勢以及在臨床申報和獲批批准的時間或可能性的監管、我們關於未來增長的預期,包括我們的產品研發能力、市場對我們的產品和產品候選者的接受程度、我們所擁有知識產權的充分保護的必要性、競爭風險、需要額外融資的風險、政府法律和法規的影響以及當前全球宏觀經濟環境對我們未來運營所需資金來源或我們未來生產、銷售和支持使用我們的產品和產品候選人的能力和能力的影響等。.

About EscharEx

關於EscharEx

EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy to use daily applications. In several 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 a Phase III study for Venous Leg Ulcers in the second half of 2024, and a Phase II/III study targeting Diabetic Foot Ulcers in the second half of 2025.

有關歐洲創新委員會加速器計劃的更多信息,請訪問

About MediWound

關於mediwound

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.

mediwound(Nasdaq:MDWD)是全球非手術組織修復創新酵素治療領域的領導者。公司專注於開發、生產和銷售快速而有效的生物製品,以提高現有的護理標準和患者體驗,並降低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, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company's lead drug under development, EscharEx. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market.

MediWound的首款藥物NexoBrid是FDA和EMA批准的孤兒生物製品,用於去除深部部分厚度和/或全厚度燒傷組織,可以顯著減少手術干預。利用相同的核心生物治療酶平台技術,MediWound開發了強大的研發管道,包括該公司正在開發的領先藥物EscharEx。 EscharEx是一種爲患者消除慢性傷口的生物治療藥物,爲市場帶來了重大潛力,並提供了重要的潛在優勢。

For more information visit and follow the Company on LinkedIn.

獲取更多信息,請訪問並在社交媒體上關注公司。LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

關於前瞻性聲明的謹慎說明

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 awarding of the EIC funding, the possibility to reach agreements regarding the investment, the EIC funding expected amount, the anticipated progress, development, timelines, expectations and commercial potential of EscharEx, including the DFU program. There can be no assurance that we will be able to receive the full award amount, reaching an agreement with the EIC, starting or completing the developed of EscharEx for DFU and/or the EscharEx will be approved for DFU indication. Among the factors that may cause results to be materially different from those stated herein are the failure to reach grant agreement and/or investment agreement between the Company and the EIC, market and other conditions, industry or political conditions in the Europe or internationally, 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 product candidates in the U.S. or other markets; 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; 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 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 our products and product candidates in the future.

EscharEx是用於治療慢性和其他難以癒合的傷口的生物活性多模式去污療法,目前處於臨床開發的前期階段。它是富含溴酶的蛋白水解酶濃縮物,可用於易於使用的局部應用。在多項二期試驗中,EscharEx已被證明是安全且耐受的。它在治療不同難以治癒傷口的去污、促進新生組織和減少活菌量和生物菌膜方面展示了療效,有效地爲癒合做好了鋪墊。MediWound準備在2024下半年開始進行靜脈性足潰瘍(VLUs)的三期研究,以及在2025年下半年開始進行鍼對糖尿病足潰瘍(DFUs)的二/三期研究。
MediWound提醒您,本新聞稿中除了歷史事實陳述以外的涉及到可能發生的未來活動、事件或發展的所有陳述都是前瞻性陳述。我們相信這裏包含的前瞻性陳述有合理的基礎,但是它們都是基於我們對未來對我們的影響的當前預期,並受到風險、假設、不確定性和因素的影響,其中很多超出了我們的控制範圍。由本新聞稿所產生的結果可能與所陳述的情況顯著不同。爲什麼會顯著不同?其中因素包括:未能達成贈款協議和/或和 EIC 達成投資協議,市場和其他條件,歐洲或國際間的相關因素、產品開發的過程的不確定性,產品開發如臨床申報和獲得的時間,產品試驗以及我們的研究和開發、FDA、EMA或其他認證機構針對決策的批准情況,市場的接受程度,以及我們關於未來的增長的預期,如能否研發新產品,市場接受所有產品等。我們鼓勵您仔細閱讀我們在”重要事項警告和投資風險”所述的風險因素和其他因素。我們未修改先前發表的任何前瞻性陳述,也不會因爲有新的信息出現,而更新之前發表的前瞻性陳述,除非法律另有要求。

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.

可能導致結果與所述因素顯著不同的因素包括與產品開發過程的不確定、漫長和昂貴的本質相關的固有不確定性;我們產品和產品候選物的研究的時間、進程和結果的時間、進展和結果,以及我們的研究和開發計劃;FDA、歐洲藥品管理局或任何其他監管機構的申報批准,我們能否在美國或其他市場上獲得產品和產品候選物的營銷批准;我們產品和產品候選物的臨床效用、潛在優勢及其遞交和批准的時間或可能性的風險;我們預計的未來增長,包括我們開發新產品的能力;我們與BARDA的合同相關的風險;市場對我們產品和產品候選物的接受程度;我們維護知識產權的充分保護的風險;競爭風險;需要額外融資;政府法律法規的影響以及當前全球宏觀經濟形勢對我們未來在運營或製造、銷售和支持使用我們的產品和產品候選物方面的能力或能力的影響。

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:
Hani Luxenburg Daniel Ferry
致富金融(臨時代碼) 董事總經理
MediWound Ltd. LifeSci Advisors,LLC
ir@mediwound.com daniel@lifesciadvisors.com
媒體聯繫人:
Ellie Hanson
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。


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