MediWound Announces €16.25 Million Funding from the European Innovation Council Accelerator Program
MediWound (Nasdaq: MDWD) has been awarded €16.25 million in blended funding from the European Innovation Council (EIC) Accelerator program. This funding will significantly advance the development of EscharEx, MediWound's innovative treatment for diabetic foot ulcers (DFUs). The package includes a €2.5 million grant and an investment with terms to be finalized.
This support will enable MediWound to expedite the market introduction of EscharEx by four years, addressing a substantial market of up to 34 million diabetic patients in the US and Europe who are at risk of developing DFUs. The funding not only recognizes EscharEx's potential impact on patients but also allows MediWound to develop it for DFUs in parallel with their advanced program for venous leg ulcers (VLUs).
- Secured €16.25 million in blended funding from the European Innovation Council
- Accelerates EscharEx development for diabetic foot ulcers by four years
- Expands potential market to 34 million diabetic patients at risk of DFUs in US and Europe
- Enables parallel development of EscharEx for DFUs and venous leg ulcers
- Recognition of EscharEx's potential impact through prestigious EIC Accelerator program selection
- None.
Insights
The announcement of MediWound securing
From a financial perspective, this funding will likely improve MediWound's cash flow situation, reducing the need for additional capital raises, which can be dilutive for current shareholders. The combination of grant and equity investment implies a strategic partnership, potentially enhancing investor confidence. Retail investors should monitor the finalized terms of the investment as it will impact the company's financial stability and ownership structure.
The diabetic foot ulcer (DFU) market is substantial, with a significant unmet need. The mention of a market size of up to 34 million diabetic patients in the US and Europe underlines the vast potential revenue streams. Short-term, investors may see an uplift in stock price due to improved financial outlook and progression optimism. Long-term, regulatory approvals from the FDA and EMA will be critical milestones to watch, as they will dictate the market introduction.
Accelerating the clinical development of EscharEx for DFUs is a strategic win for MediWound. Diabetic foot ulcers are a severe complication of diabetes, leading to infections, amputations and even death if untreated. With 70% of DFU patients requiring debridement, EscharEx addresses a important therapeutic gap.
This funding allows MediWound to simultaneously advance EscharEx for both DFUs and venous leg ulcers (VLUs), broadening its therapeutic portfolio. The ability to expedite timelines by four years is remarkable, offering earlier access to a promising treatment for millions of patients.
Furthermore, the support and recognition from the EIC Accelerator, a prestigious and competitive program, validate the potential of EscharEx. This external endorsement may positively influence regulatory bodies like the FDA and EMA, facilitating smoother approval processes.
Retail investors should note that while the future market potential is enormous, the path to market still entails rigorous clinical trials and regulatory scrutiny. The success of such trials and subsequent approvals will be pivotal in realizing the full potential of this funding.
Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs)
Award advances MediWound’s DFU program and its future revenues four years ahead of original schedule
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
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
"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."
With
For more information about the EIC Accelerator, visit https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en.
About 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.
About 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’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
For more information visit www.mediwound.com and follow the Company on LinkedIn.
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 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.
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.
| 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 |
FAQ
What funding did MediWound (MDWD) receive for EscharEx development?
How will the EIC funding impact MediWound's (MDWD) EscharEx development timeline?
What is the potential market size for EscharEx in treating diabetic foot ulcers (DFUs)?
How does the EIC funding affect MediWound's (MDWD) development strategy for EscharEx?
