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Our Mission
Caring. Innovating. Delivering.
Committed to innovation, we are dedicated to bringing breakthrough therapies to improve patients’ lives.
Our strategy leverages our enzymatic technology platform, delivering next-generation biotherapeutic solutions for tissue repair and regeneration.
NexoBrid®, our first commercial orphan biological product for non-surgical and rapid eschar removal of severe burns, does not harm surrounding viable tissue.
EscharEx®, our next-generation bioactive therapy for debridement of chronic and hard- to-heal wounds, is a product candidate in advanced stages of development.
MW005, our topical enzymatic therapy for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
People
We care about ethics and respect the dignity of every individual
Innovation
We maintain our scientific and development edge to improve standard of care
Value
We deliver value to our customers, enabling greater patient satisfaction
Quality
We continually learn and advance as quality comes first across the company
The full solution
A Fully-Integrated Biopharmaceutical Company
MediWound has extensive history and experience developing, manufacturing,
and commercializing regenerative medicinal products
RESEARCH & DEVELOPMENT
In-house Expertise
- In-vitro and In-vivo models
- Analytical methods development
- Product formulation
- Clinical development and data generation
- Regulatory processes
MANUFACTURING
State of the Art Facility
- cGMP certified
- Experienced team
- Capable of aseptic processing for sterile products
- Product Development manufacturing suites
Commercialization
Wide global network
- EU direct sales force
- Multiple distribution agreements
- Extensive worldwide supply chain
20
years
150
publications
3
Products
50
COUNTRIES
2
Strategic partnerships
$202M
Governmental Support
Press Releases
MediWound Announces U.S. FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
MediWound Ltd. (Nasdaq: MDWD) (“MediWound”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently re-submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of January 1, 2023
MediWound to Present at Upcoming Investor Conferences
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a
fully-integrated biopharmaceutical company focused on next-generation biotherapeutic
solutions for tissue repair and regeneration, today announced that management will present
at the following investor conferences during the month of September 2021.
MediWound Reports Second Quarter Financial Results
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ended June 30, 2021
MediWound Announces Positive Outcome of Interim Assessment for its EscharEx U.S. Phase 2 Adaptive Design Study
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement)
MediWound Announces Initiation of U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021
MediWound Announces Positive Topline Results from Phase 3 Pediatric Study (CIDS) of NexoBrid for Eschar Removal of Severe Thermal Burns
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced positive topline results from its pivotal phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study) with NexoBrid® to treat children with severe thermal burns, evaluating the efficacy and safety compared with standard-of-care (SOC)
MediWound Announces Peer-Reviewed Paper Detailing EscharEx Phase 2 Randomized Control Trial Results Published in the Online Wound Repair and Regeneration Journal
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication, detailing the results of a phase 2 randomized control trial of its wound debriding product candidate EscharEx®, has been published in the Wound Repair and Regeneration Journal. An interim assessment of EscharEx's U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) is expected by end of July 2021
MediWound Receives Complete Response Letter from U.S. FDA for NexoBrid Biologics License Application
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns
MediWound Completes Patient Enrollment for Interim Assessment of its U.S. EscharEx Phase 2 Adaptive Design Study
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the enrollment target of patients for an interim assessment of its EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement)
MediWound Announces Peer-Reviewed Paper of a Case Series Report of Basal Cell Carcinoma Published in the Open Dermatology Journal
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that a peer-reviewed publication of a case series report of basal cell carcinoma (BCC) destruction by a concentrate of proteolytic enzymes enriched in bromelain has been published in the Open Dermatology Journal. MediWound anticipates initiating a phase I/II clinical study of MW005 for the treatment of BCC this month, with data expected by the end of 2021
MediWound Reports First Quarter 2021 Financial Results
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced financial results for the first quarter ended March 31, 2021
MediWound Enrolls First Patient in Phase 2 Pharmacology Study of EscharEx
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it has enrolled the first patient in its phase 2 pharmacology study of EscharEx®, its next-generation enzymatic debridement agent under development for chronic wounds, with data expected in the second half of 2021
MediWound Reports Fourth Quarter and Full-Year 2020 Financial Results
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced financial results for the fourth quarter and full-year ended December 31, 2020
MediWound Launches Clinical Development Program for Treatment of Non-Melanoma Skin Cancer
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced the initiation of a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. MediWound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the United States in the second quarter of 2021. A phase II investigator-initiated trial of MWPC005 in non-melanoma skin cancer will be conducted in parallel at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be generated by the end of 2021
MediWound Provides Progress Update on Its EscharEx Clinical Development Program
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on its EscharEx® clinical development program
Successful Completion of In-Vivo Head-to-Head Comparator Study of EscharEx versus a Commercial Enzymatic Debridement Agent
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the successful completion of a pre-clinical study designed to evaluate the debridement efficacy of EscharEx®, a novel bromelain-based enzymatic debridement agent, in a porcine hard-to-heal wound model, and compare its efficacy with an FDA approved and commercially available collagenase enzymatic debridement agent. The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. Results from the study will be published in a peer-reviewed journal in the first half of 2021
MediWound Continues Global Expansion with Distribution Agreement for NexoBrid in United Arab Emirates with Ghassan Aboud Group
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has further expanded its NexoBrid® global presence and entered the Middle Eastern markets with the signing of a distribution agreement granting Ghassan Aboud Group (GAG), an international conglomerate based in the United Arab Emirates (UAE), an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns. Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year
MediWound Reports Third Quarter 2020 Financial Results
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the third quarter ended September 30, 2020
MediWound Completes Enrollment Stage of its NexoBrid Phase 3 Pediatric Study
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid® Phase 3 pediatric clinical study (CIDS - Children Innovation Debridement Study). Top-line results with 12 months follow up data anticipated during the second half of 2021. Additionally, the completion of the CIDS enrollment stage follows the U.S. Food and Drug Administration (FDA)’s recent agreement to allow the NexoBrid expanded access (NEXT) protocol to be expanded to include pediatric as well as adult burn patients
MediWound Studying the Effect of EscharEx on Biofilm Burden
MediWound Ltd. (Nasdaq: MDWD) ("MediWound”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it is exploring the pharmacological effect of EscharEx® on biofilm burden associated with chronic wounds based on the scientific evidence showing that enzymatic debridement might be an effective means to treat and reduce the biofilm burden
MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
MediWound Ltd. (Nasdaq: MDWD) (the “MediWound”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application
MediWound and Vericel Announce Acceptance of the First Delivery of NexoBrid to BARDA for Emergency Response Preparedness
MediWound Ltd. (NASDAQ: MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ: VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million
MediWound Reports Second Quarter 2020 Financial Results and Provides Corporate Update
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic
MediWound Announces Submission of Biologics License Application to the U.S. FDA for NexoBrid for the Treatment of Severe Thermal Burns
dress unmet medical needs in severe burn and wound management, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns
MediWound Reports First Quarter 2020 Financial Results and Provides Corporate Update
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the first quarter ended March 31, 2020 and provided business and financial updates related to the COVID-19 pandemic
MediWound Strengthens its NexoBrid European Presence with Additional Distribution Agreements
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced the expansion of its NexoBrid® European presence with distribution agreements granting GENFA MEDICA SA, its distributer in Russia, Ukraine and the Baltic countries, the exclusive right to market and distribute NexoBrid in France and Switzerland and Specialty Therapeutics PC the exclusive right to market and distribute NexoBrid in Greece, Bulgaria, Malta and Cyprus
MediWound Strengthens Board of Directors
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the appointments of Mr. Samuel Moed and Mr. David Fox to its Board of Directors to serve until the 2020 annual meeting of shareholders. Stephen T. Wills, MediWound’s Chairman since 2018, was named Executive Chairman
MediWound Provides Corporate Update Related to COVID-19 Pandemic
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on certain impacts of the COVID-19 pandemic on its business operations and clinical programs
BARDA Upsizes its Contract with MediWound Awarding an Additional $5.5 Million for Emergency Readiness for NexoBrid Deployment
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has expanded its awarded contract with MediWound providing supplemental funding of $5.5 million to support emergency readiness for NexoBrid deployment upon request of use of NexoBrid in mass casualty situation
MediWound Reports Fourth Quarter and Full-Year 2019 Financial Results
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced financial results for the fourth quarter and full-year ended December 31, 2019
MediWound Expands its Distribution Agreement with GENFA MEDICA SA to Market NexoBrid in Ukraine and the Baltic States
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the expansion of its agreement with GENFA MEDICA SA, granting it the exclusive right to market and distribute NexoBrid® in Ukraine, Lithuania, Latvia and Estonia adding to its current rights to distribute NexoBrid in Russia
BARDA Initiates the Procurement of NexoBrid for Emergency Response
MediWound Ltd. (NASDAQ: MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ: VCEL) today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Assistant Secretary for Preparedness and Response (ASPR), a part of the U.S. Department of Health and Human Services (HHS), has begun procuring NexoBrid® for emergency stockpile as part of the HHS mission to build national preparedness for public health medical emergencies. BARDA purchased inventory will be managed by MediWound under vendor managed inventory. The initial BARDA procurement is valued at $16.5 million, with the first delivery of NexoBrid expected by the end of the first quarter of 2020 and additional deliveries occurring over the subsequent five quarters. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. The submission of the Biologics License Application (BLA) for NexoBrid to the U.S. Food & Drug Administration (FDA) is planned for the second quarter of 2020
MediWound Continues NexoBrid’s Global Expansion Through a New Distribution Agreement in Australia, New Zealand and Singapore with Balance Medical
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the signing of a distribution agreement granting Balance Medical Pty Ltd. the exclusive rights to market and distribute NexoBrid® in Australia, New Zealand and Singapore for the treatment of severe burns. NexoBrid is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns, which is approved in the European Union and other international markets. Commercialization of NexoBrid in these territories will commence after receipt of the respective local regulatory authorities approval, which is expected within two years. Balance Medical will employ a special access scheme (SAS) in Australia, to allow treatment of patients prior to marketing approval, using unapproved therapeutic medicines under exceptional clinical circumstances
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