INVESTORS

Next Generation Enzymatic Therapeutics for Non-Surgical Tissue Repair

Redefining the Standard of Care

Our Mission

Caring. Innovating. Delivering.

Committed to innovation, we are dedicated to enhancing  standard of care and improving patient lives.

MediWound is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.

 

NexoBrid® is our commercial orphan biologic drug for early non-surgical eschar removal of deep-partial and full-thickness thermal burns. It is a bromelain-based gel containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently approved in the United States, European Union, Japan, India, and other international markets. This has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201500035C.

 

EscharEx® is MediWound’s leading biologic currently in development, utilizing the same active pharmaceutical ingredient found in NexoBrid. It is specifically designed for the debridement of chronic and hard-to-heal wounds. Promising results from Phase 2 studies demonstrate that EscharEx is highly effective and significantly faster than standard-of-care (SOC) treatments or placebo control in debriding venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). Furthermore, EscharEx exhibits a strong safety profile and excellent tolerability. The initiation of the Phase 3 study is anticipated in second half of 2024, marking a significant milestone in the development of EscharEx.

 

MW005 is an innovative topical biological drug currently in development to address the treatment needs 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. The trial continues to progress, and we eagerly anticipate the release of results in Q3 2023, which will provide valuable insights into the future of MW005 as a promising therapy for low-risk Basal Cell Carcinoma.

 

 

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 biologics based on our core enzymatic technology.

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

Summing up Success

MediWound Facts and Figures

MediWound_onepager_
MediWound - April 2024
23

Years

120

Publications

3

Products

44

Countries

5

Strategic partnerships

$216M

US Governmental Support

Press Releases

MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update

March 21, 2024

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a
corporate update.

MediWound to Report Fourth Quarter and Full Year 2023 Financial Results

March 14, 2024

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair, today announced that the Company will release its financial results for the fourth quarter and full year ended December
31, 2023 on Thursday, March 21, 2024.
Following the release, management will h

MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx® vs. SANTYL® within the ChronEx Phase II Randomized Controlled Study

February 12, 2024

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair today announced the results of head-to-head comparison analyses of EscharEx, the Company’s lead asset in
development for chronic wounds, to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers. SANTYL is currently the
market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States.

MediWound to Participate in Two Upcoming Investor Conferences

February 5, 2024

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming Oppenheimer 34th Annual Life Sciences
Conference, taking place virtually on February 13-14, 2024, as well as the upcoming TD Cowen 44th Annual Health Care Conference, taking place in
Boston on March 4-6, 2024.

MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns

January 9, 2024

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing
review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep
partial- and/or full-thickness thermal burns

MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army

December 28, 2023

- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of Defense (DoD), through the Medical
Technology Enterprise Consortium (MTEC), has awarded MediWound an additional $6.7 million in non-dilutive funding to develop NexoBrid® as a
non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $14.4 million project budget will
advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for
treating severe burn injuries in pre-hospital settings. Vericel Corporation holds an exclusive license encompassing the commercial and development
rights to NexoBrid in North America as set forth in the license agreement between the Company and Vericel.

MediWound Announces Peer-Reviewed Publication of EscharEx® Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial Loads

December 21, 2023

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair today announced the publication of a peer-reviewed paper, titled “An Open-label, Proof of Concept Study, Assessing the
Effects of Bromelain-Based Enzymatic Debridement on Biofilm and Microbial Loads in Patients with Venous Leg and Diabetic Foot Ulcers” in the
December 2023 issue of WOUNDS Journal.

MediWound Reports Third Quarter 2023 Financial Results and Provides Company Update

November 21, 2023

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair, today announced financial results for the third quarter ended September 30, 2023, and provided a corporate update.

MediWound Announces Appointment of Shmulik Hess, Ph.D. as Chief Operating Officer and Chief Commercial Officer

November 21, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced the appointment of Shmulik Hess, Ph.D. to the positions of Chief Operating
Officer and Chief Commercial Officer effective as of December 1, 2023. Dr. Hess will lead and oversee all operational and commercial activities at
MediWound.

MediWound to Report Third Quarter 2023 Financial Results

November 14, 2023

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair, today announced that the Company will release its financial results for the third quarter ended September 30, 2023 on
Tuesday, November 21, 2023.

MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients

November 13, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in
Europe to include all age groups for removal of eschar in patients with deep part

MediWound Announces a Collaboration with PolyMedics Innovations (PMI) for NexoBrid® Distribution in Europe

November 8, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated
biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, and PolyMedics Innovations (PMI), an innovative
biomaterials company specializing in effective wounds treatment, today announced an agreement for the promotion of NexoBrid® in Germany, Austria,
Belgium, the Netherlands and Luxemburg.

MediWound Announces Collaboration with 3M on EscharEx® Phase III Study

October 11, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced collaboration with 3M Health Care. 3M Health Care will provide its market
leading two-layer compression systems Coban™ 2 and Coban™ 2 Lite to be used during the debridement and wound healing phases of the EscharEx
Phase III study.

MediWound Deploys NexoBrid® for Emergency Supply

October 9, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, addresses emergency demand for NexoBrid to treat the mass of burn casualties, inflicted by
the war in Israel.
Hospitals and military forces have urgently requested NexoBrid supplies. To address this critical need, MediWound has deployed all its available
NexoBrid inventory to aid the substantial number of burn victims.
MediWound remains committed to fulfilling its obligations to our global markets and is implementing measures to ensure supply continuity.

MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army

September 26, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of Defense (DoD), through the Medical
Technology Enterprise Consortium (MTEC), has awarded MediWound additional funding to develop NexoBrid® as a non-surgical solution for field-care
burn treatment for the U.S. Army (the “MTEC Research Project Award”). The $6.5 million project budget will advance the development of a new,
temperature stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings

MediWound Announces U.S. Commercial Availability of NexoBrid® for the Treatment of Severe Thermal Burns in Adults

September 21, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced the U.S. commercial availability of NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns.

MediWound’s NexoBrid® Highlighted in 20 Oral and Poster Presentations at the 20th European Burns Association Congress

September 11, 2023

MediWound Ltd. (Nasdaq: MDWD) (“MediWound”), a fully integrated biopharmaceutical
company focused on next-generation enzymatic therapeutics for tissue repair, today announced its successful participation at the recently concluded
20th European Burns Association (EBA) Congress held in Nantes, France on September 6-9, 2023.

MediWound to Participate in Fireside Chat at H.C. Wainwright 25th Annual Global Investment Conference

September 5, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming H.C. Wainwright 25th Annual Global Investment Conference. The conference will take place in New York City and virtually from September 11-13, 2023.

MediWound Announces Collaboration with Mölnlycke on EscharEx® Phase III Study

August 15, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced a research collaboration agreement with Mölnlycke for its upcoming Phase III study of EscharEx® in venous leg ulcers (VLUs). Mölnlycke will provide Mepilex® Up, its most recent line extension to its global market leading brand, along with Exufiber® and Exufiber® Ag dressings to be used during the wound healing phase of the study.

MediWound Announces Collaboration with MIMEDX on EscharEx® Phase III Study

August 15, 2023

MediWound to join forces with leading chronic wound allograft company in pivotal study for patients with venous leg ulcers
YAVNE, Israel, Aug. 15, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has entered into a research collaboration agreement with MIMEDX Group, Inc (Nasdaq: MDXG). MIMEDX will provide its market leading placental tissue allograft EPIFIX® to be used during the wound healing phase of the EscharEx® Phase III study in venous leg ulcers (VLUs).

MediWound Reports Second Quarter 2023 Financial Results and Provides Company Update

August 15, 2023

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2023, and provided a corporate update.

MediWound to Report Second Quarter 2023 Financial Results

August 7, 2023

MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the second quarter ended June 30, 2023 on Tuesday, August 15, 2023.

Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.

MediWound Announces Commercial Launch of NexoBrid® in Japan

August 1, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid® in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan

MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study Design

July 3, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization.

MediWound to Participate in Fireside Chat at Maxim Group Healthcare Virtual Conference 2023

June 14, 2023

YAVNE, Israel, June 14, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on
next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming Healthcare Virtual Conference Part II,
organized by Maxim Group LLC and hosted by M-Vest. The conference will take place online from June 20 to June 22, 2023.

MediWound Reports First Quarter 2023 Financial Results and Provides a Company Update

May 23, 2023

YAVNE, Israel, May 30, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic
therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.
"This quarter has been extremely productive as our dedicated team has worked diligently to advance the key components of our strategic plan. The
outcomes of our focused efforts are evident, as we are on track to initiate the Phase III study for our flagship product, EscharEx, in the fourth quarter of
this year. This represents a significant commercial opportunity and addresses a major unmet need. Furthermore, we are excited to partner with Vericel
for the upcoming U.S. launch of NexoBrid. Simultaneously we are making rapid progress in our manufacturing scale-up plan to meet the surging global
demand. Importantly, MediWound is now in a strong financial position, with over $57 million in cash. This provides the company with ample resources
to effectively execute its corporate initiatives and drive continuous innovation," stated Ofer Gonen, Chief Executive Officer of MediWound.

MediWound to Report First Quarter 2023 Financial Results

May 12, 2023

MediWound to Report First Quarter 2023 Financial Results
Conference Call and Webcast Scheduled for Tuesday, May 30th at 8:30 am Eastern Time YAVNE, Israel, May 12, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its

MediWound Announces an Additional $10 Million Award from BARDA

May 9, 2023

MediWound Announces an Additional $10 Million Award from BARDA
Funding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extension YAVNE, Israel, May 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic

MediWound to Present Phase 2 EscharEx® Data at the Symposium on Advanced Wound Care (SAWC) Spring 2023

April 26, 2023

MediWound to Present Phase 2 EscharEx® Data at the Symposium on Advanced Wound Care (SAWC) Spring 2023
Data to be highlighted in oral and poster presentations YAVNE, Israel , April 26, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic solutions for tissue repair, today announced the Company will present updated

MediWound Reports Fourth Quarter and Full Year 2022 Financial Results and Company Update

March 16, 2023

MediWound Reports Fourth Quarter and Full Year 2022 Financial Results and Company Update
2022 total revenues of $26.5 million FDA approval of NexoBrid ® in December 2022 ; U.S. commercial availability expected in the second quarter of 2023 EscharEx ® Phase III protocol design is under review by the FDA; study to be initiated in the second half of 2023 C ash position of $66 million ,

MediWound Announces the Appointment of Hani Luxenburg as Chief Financial Officer

March 16, 2023

YAVNE, Israel , March 16, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company specializing in next-generation biotherapeutic solutions for tissue repair and regeneration, is pleased to announce the appointment of Ms.

MediWound Expands its Global Leadership Team to Help Drive Company’s Future Growth

March 6, 2023

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

March 3, 2023

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

February 23, 2023

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

February 7, 2023

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

February 3, 2023

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

December 29, 2022

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

December 23, 2022

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®

December 20, 2022

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

December 19, 2022

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

December 13, 2022

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

December 5, 2022

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

November 15, 2022

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 Announces Positive Results in Its U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma

July 10, 2023

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, 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 show MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.

MediWound’s EscharEx Featured in Paper as a Potential Paradigm Shift Towards Non-Surgical Wound Bed Preparation in DFUs

November 9, 2022

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

November 3, 2022

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

October 25, 2022

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

October 18, 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

October 7, 2022

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

September 22, 2022

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

September 20, 2022

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

September 12, 2022

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

August 9, 2022

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

August 8, 2022

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

August 3, 2022

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

September 3, 2021

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

August 10, 2021

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

July 28, 2021

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

July 26, 2021

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

July 20, 2021

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

July 9, 2021

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

June 29, 2021

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

June 9, 2021

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

June 7, 2021

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

May 5, 2021

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

April 22, 2021

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

February 25, 2021

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

February 22, 2021

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

January 11, 2021

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

December 13, 2023

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

December 29, 2022

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

December 21, 2020

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

December 14, 2020

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

November 10, 2020

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

October 28, 2020

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

October 14, 2020

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

September 16, 2020

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

August 25, 2020

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

August 6, 2020

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

June 30, 2020

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

May 20, 2020

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

May 4, 2020

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

April 27, 2020

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

March 30, 2020

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

March 3, 2020

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

February 25, 2020

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

January 13, 2020

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

January 6, 2020

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

January 2, 2020

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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