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Our Mission
Caring. Innovating. Delivering.
Committed to innovation, we are dedicated to enhancing standard of care and improving patient lives.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is to leverage our enzymatic technology platform, focusing on next-generation therapies for burn care, wound care, and tissue repair.
NexoBrid® is our commercial orphan biological product for early non-surgical eschar removal of deep-partial and full-thickness thermal burns. It is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union, Japan, India, and other international markets, and recently received FDA approval for marketing in the U.S. NexoBrid is supported by the US Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS).
EscharEx® .
EscharEx® is based on the same active pharmaceutical ingredient as NexoBrid. It is under development for the debridement of chronic and hard-to-heal wounds. Results from Phase 2 studies show that EscharEx is significantly more effective and faster than SOC or placebo control in debridement of VLUs and DFUs, with a good safety and tolerability profile. MediWound has initiated discussions with the FDA regarding the EscharEx pivotal Phase 3 study design.
MW005
MW005 is a topical biological drug under development for the treatment of low-risk Basal Cell Carcinoma (BCC). In a Phase I/II open-label, multicenter, randomized clinical trial conducted in the U.S., MW005 was shown to be safe, well-tolerated, and an effective treatment for BCC with patients demonstrating complete clinical and histological clearance of target lesions.
People
We care about ethics and respect the dignity of every individual
Innovation
We maintain our scientific and developmental edge to improve standard of care
Value
We deliver value to our customers, enabling greater patient satisfaction
Quality
We strive to attain the highest quality in all of our products
The 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
- Product formulation
- Clinical research and data generation
- Regulatory processes
MANUFACTURING
State of the Art Facility
- cGMP certified
- Experienced team
- Aseptic processing for sterile products
- Product Development manufacturing suites
COMMERCIALIZATION
Wide global network
- EU direct sales force
- Strategic collaborations including Vericel, Kaken, BSV, GAG
- Extensive worldwide supply chain
- BARDA and DoD support
20
Years
100
Publications
3
Products
44
Countries
4
Strategic partnerships
$211M
US Governmental Support
Press Releases
MediWound Expands its Global Leadership Team to Help Drive Company’s Future Growth
MediWound Ltd. (NASDAQ: MDWD) (the “Company”), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the appointment of Barry Wolfenson as Executive Vice President of Strategy & Corporate Development.
MediWound to Report Fourth Quarter and Year-End 2022 Financial Results
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the fourth quarter and year ended December 31, 2022 on Thursday, March 16, 2023.
MediWound to Present Corporate Highlights 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 management will present at two upcoming investor conferences in March.
MediWound Announces Closing of $27.5 Million Registered Direct Offering of Ordinary Shares
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the closing of its previously announced registered direct offering. The gross proceeds to the Company from the offering were $27.5 million, before deducting placement agent fees and other offering expenses payable by the Company.
MediWound Announces $27.5 Million Registered Direct Offering of Ordinary Shares Priced At-The-Market
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 it has entered into a definitive securities purchase agreement for the sale and purchase of1,964,286 shares of the Company’s ordinary shares, par value NIS 0.07, at a purchase price of $14 per share, in a registered direct offering.
MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
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 the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan
MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that its partner, Kaken Pharmaceutical Co., Ltd. has gained marketing approval of NexoBrid® in Japan. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive right to market and distribute NexoBrid in Japan. Kaken Pharmaceutical expects to launch NexoBrid in the summer of 2023.
MediWound Strengthens European Presence of NexoBrid®
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the marketing approval of NexoBrid® in Switzerland. MediWound has signed an agreement with Triskel Integrated Services to market and distribute NexoBrid in Switzerland, with a launch planned for the first quarter of 2023. Triskel also holds the distribution rights of NexoBrid in France, where NexoBrid is expected to launch in the third quarter of 202
MediWound Announces Positive Results in U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company, focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data shows MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. MW005 contains the same active pharmaceutical ingredient as in NexoBrid® and EscharEx®. The results of this study represent further demonstration of the efficacy of MediWound’s core enzymatic platform technology across various indications. Based on these positive results, MediWound plans to continue enrolling patients in its Phase I/II study, optimizing its dosing regimen and application technique. The results are expected in 2023.
MediWound Expands Global Presence as NexoBrid® Gains Approval in India
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced it has gained marketing approval of NexoBrid® in India. MediWound has signed an agreement granting Bharat Serums and Vaccines Limited (BSV), a leading biopharmaceutical company in India, the exclusive right to market and distribute NexoBrid in India for the treatment of severe burns. BSV is expected to begin commercializing NexoBrid in India in the first half of 2023.
MediWound Announces a 1-for-7 Reverse Share Split
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.
MediWound Reports Third Quarter 2022 Financial Results and Provides Company Update
YAVNE, Israel, Nov. 15, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.
MediWound’s EscharEx Featured in Paper as a Potential Paradigm Shift Towards Non-Surgical Wound Bed Preparation in DFUs
YAVNE, Israel, Nov. 09, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the publication of a paper, “Introducing Bromelain-Based Enzymatic Debridement” in the journal Podiatry Management. The paper reviewed past studies and summarized physicians’ experiences in using EscharEx® for the debridement and wound bed preparation of Diabetic Foot Ulcers (DFUs).
MediWound to Report Third Quarter 2022 Financial Results
YAVNE, Israel, Nov. 03, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the third quarter ended September 30, 2022 on Tuesday, November 15, 2022.
MediWound Announces Formation of Strategic Advisory Board
YAVNE, Israel, Oct. 25, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the establishment of a Strategic Advisory Board (SAB). The inaugural members of the MediWound SAB represent a diverse group of experienced executives who bring a depth and breadth of strategic insight to guide the Company.
MediWound's EscharEx® Featured in Oral and Poster Presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022
YAVNE, Israel, Oct. 18, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that positive clinical data from the Company’s EscharEx® Phase 2 trials was featured in an oral and two poster presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022 Conference in Las Vegas, Nevada. The abstract poster chosen for oral presentation was one of four posters selected out of 290 abstracts presented.
MediWound Announces Closing of the Concurrent Registered Direct and Private Placement Offerings
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the closing of its previously announced registered direct and PIPE offerings (the "Offerings"). The gross proceeds to the Company from the Offerings were $30.5 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offerings primarily for the development of EscharEx®, scale up of its facilities, and for general corporate purposes.
MediWound Announces Concurrent Registered Direct and Private Placement Offerings Priced At-the-Market of Approximately $30 Million
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 it has entered into a definitive securities purchase agreement with several institutional and accredited investors (the “Registered Direct Securities Purchase Agreement”) for the sale and purchase of 7,575,513 shares of the Company’s ordinary shares, par value NIS 0.01 (the “Ordinary Shares”), at a purchase price of $1.75 per share, in a registered direct offering (the “Registered Direct Offering”). Additionally pursuant to the Registered Direct Securities Purchase Agreement, the Company has also agreed to issue to these investors unregistered warrants (the “Warrants”) to purchase up to 7,575,513 Ordinary Shares in a concurrent private placement. The Warrants will have an exercise price of $1.925 per Ordinary Share and will become exercisable upon the Company’s receipt of shareholder approval to increase the number of its authorized Ordinary Shares, pursuant to the Company’s Amended and Restated Articles of Association, and will expire four years thereafter. The gross proceeds of the Registered Direct Offering are expected to be approximately $13.26 million. The Company expects the Registered Direct Offering to close on or about September 26, 2022, subject to the satisfaction of customary closing conditions
EMA Accepts MediWound’s Application for Extended Indication for NexoBrid to Treat Pediatric Patients with Severe Thermal Burns
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 the European Medicines Agency (EMA) has validated for review the Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid (removal of eschar in adults with deep partial-and full-thickness thermal burn wounds) into the pediatric population. MediWound expects a decision from the European Commission in the first quarter of 2023.
MediWound’s NexoBrid® Highlighted in 45 Posters and Presentations at the 19th European Burns Association Congress
MediWound Ltd. (Nasdaq: MDWD) (“MediWound”), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced its successful and meaningful presence at the recently concluded 19th European Burns Association (EBA) Congress held in Turin, Italy on September 7-10, 2022.
MediWound Reports Second Quarter 2022 Financial Results and Provides Company Updates
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ending June 30, 2022.
MediWound Enhances Its Board and Executive Leadership Team
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the appointments of Mr. Nachum (Homi) Shamir as the Chairman of the Company’s Board of Directors and Dr. Robert Snyder as the Company’s Chief Medical Officer.
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
MediWound Expands Global Presence as NexoBrid® Gains Approval in India
MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced it has gained marketing approval of NexoBrid® in India. MediWound has signed an agreement granting Bharat Serums and Vaccines Limited (BSV), a leading biopharmaceutical company in India, the exclusive right to market and distribute NexoBrid in India for the treatment of severe burns. BSV is expected to begin commercializing NexoBrid in India in the first half of 2023.
MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
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 the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
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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