MediWound Ltd., a biopharmaceutical company, which develops, manufactures and commercializes novel, bio-therapeutic, non-surgical solutions for tissue repair and regeneration.
The company's solutions selectively remove non-viable hazardous tissue while preserving healthy tissue, offering a safer and more effective alternative to traditional methods. With robust in-house research, development, and manufacturing capabilities, the company produces and commercializes cutting-edge biologics for woun...
MediWound Ltd., a biopharmaceutical company, which develops, manufactures and commercializes novel, bio-therapeutic, non-surgical solutions for tissue repair and regeneration.
The company's solutions selectively remove non-viable hazardous tissue while preserving healthy tissue, offering a safer and more effective alternative to traditional methods. With robust in-house research, development, and manufacturing capabilities, the company produces and commercializes cutting-edge biologics for wound and burn care that exceed existing standards of care, improve patient outcomes, and reduce healthcare costs by eliminating the need for surgical interventions.
The company’s flagship product, NexoBrid, is a topically administered biological orphan drug that enzymatically removes eschar while preserving viable tissue in patients with deep partial- and full-thickness thermal burns. It is approved for use in more than 40 countries, including the United States, in the European Union, and Japan.
Building on the company's proprietary enzymatic technology, it is advancing EscharEx, a Phase III pipeline drug for the treatment of chronic wounds. EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic, and other hard-to-heal wounds, currently in the advanced stages of clinical development. In three Phase II clinical trials, EscharEx has demonstrated a strong safety profile and efficacy in debridement, granulation tissue promotion, and the reduction of bioburden, and biofilm, effectively preparing wound beds for healing. In February 2025, the company announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). In addition to the VALUE study, the company plans to initiate a randomized, head-to-head Phase II study in 2025, comparing EscharEx to collagenase in VLU patients. Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026.
The company’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.
The company manufactures NexoBrid and its product candidates in the company’s cGMP certified sterile manufacturing facility at its headquarters in Yavne, Israel.
Operations
In July 2023, the company signed a turnkey scale-up agreement (the Scale-up Agreement) to establish, commission, and validate a cutting-edge, sterile, and GMP-compliant manufacturing facility. Construction of the new GMP-compliant, state-of-the-art manufacturing facility was completed as of August 2024, with commissioning underway. The facility is expected to reach full operational capacity by the end of 2025, increasing manufacturing output sixfold. Commercial availability will depend on securing the necessary regulatory approvals.
Focus
Burn Care
NexoBrid, a concentrate of proteolytic enzymes enriched in bromelain, is a topically administered biological orphan drug that enzymatically removes eschar while preserving viable tissue in patients with deep partial- and full-thickness thermal burns. It is approved in more than 40 countries, including the United States, European Union, and Japan. NexoBrid has been investigated in hundreds of patients across more than 22 countries and four continents in ten completed Phase II, Phase III and post-marketing clinical studies.
Burn Wounds
In February 2025 the company announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting DFUs, which is expected to begin in 2026.
In March 2025 the company announced the expansion of the strategic research collaborations with leading wound care companies to optimize study execution and patient outcomes. Coloplast will support the Phase II/III DFU trial, alongside Solventum, Mölnlycke, and MIMEDX, who are contributing to the VLU trials. These industry leaders will supply advanced wound care products to ensure consistent management across all study sites.
In February 2024 the company announced a head-to-head comparative post-hoc analysis of EscharEx vs SANTYL. Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures: incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. In addition to the VALUE study, the company plans to initiate a randomized, head-to-head Phase II study in VLU patients in 2025, comparing EscharEx to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers, and to Iruxol, the version of collagenase approved for use and marketed in certain countries in Europe.
Ongoing Clinical Trials
Phase III Pivotal Trial of EscharEx for Venous Leg Ulcers
In February 2025 the company initiated the VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs).
The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the U.S. and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over two weeks, followed by ten weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks.
To support the trial, the company has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes.
Completed Clinical Trials
The company completed a first Phase II feasibility study in Israel for chronic and other hard-to-heal wounds. In January 2017 it completed and announced the final results of a second Phase II prospective study in Israel and Europe. In November 2017, the company announced the final results of a second cohort of the second Phase II study.
First Phase II Feasibility Study-Israel
This first Phase II feasibility study was conducted in Israel to study the efficacy of the company’s technology on chronic and other hard-to-heal wounds. The study assessed 24 patients at two sites. The results showed that its technology demonstrated positive efficacy results in debriding various chronic and other hard-to-heal wound etiologies, such as VLUs, DFUs, pressure sores and trauma on diseased skin.
Second Phase II study-Israel/EU - First Cohort
This second Phase II study was a prospective, controlled, assessor-blinded, randomized, multi-center Phase II study in Israel and Europe. The study objectives were to evaluate the efficacy and safety of EscharEx in comparison to the Gel Vehicle at a ratio of 2:1 for the treatment of a variety of chronic and other hard-to-heal wounds in three etiologies: DFUs, VLUs and post-surgical or traumatic hard-to-heal wounds.
Second Phase II study-Israel/EU - Second Cohort
After successfully completing the first cohort of the study which included 73 patients recruited in 15 clinical sites, the company initiated a second cohort of patients to evaluate safety and tolerability over extended periods of application. In this second cohort, it recruited 38 patients from two etiologies, either VLUs or DFUs, over extended periods of application (24-72 hours) with up to eight applications, randomizing the patients to two study arms EscharEx or gel vehicle at a ratio of 2:1. The primary objective was to assess safety.
EscharEx U.S. Phase II Study in Venous Leg Ulcer (VLU) Patients
In December 2019, the company initiated a U.S. Phase II adaptive design clinical study of EscharEx for the treatment of VLUs. The study was a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs compared to gel vehicle (placebo control) and non-surgical standard-of-care of either enzymatic or autolytic debridement (NSSOC).
Non-Melanoma Skin Cancer
MW005 is a topically applied biological product candidate for the treatment of non-melanoma skin cancers, based on the same active substance of NexoBrid and EscharEx, a concentrate of proteolytic enzymes enriched in bromelain. The clinical development plan of MW005 is supported by the results from several toxicological and other preclinical studies, as well as vast clinical experience from NexoBrid and EscharEx, which share the same API.
Although the company has conducted preclinical trials, the development of MW005 for non-melanoma skin cancer indications is still in its preliminary phase and there is no certainty that it will achieve all the aims of the trials as required and/or successfully complete the approval process for such indication.
Pre-Clinical and Clinical Studies
The company conducts clinical studies and preclinical studies to support the efficacy and safety of its products and their ingredients, and to extend and validate their benefits for human health. Preclinical studies allow it to substantiate the safety of its products and obtain preliminary indications of their pharmacological and safety profile. As of the date hereof, the company has conducted more than 50 non-GLP and GLP preclinical studies. All preclinical safety and toxicology studies were conducted according to the principles of Good Laboratory Practices (GLP), and thirteen clinical studies were conducted according to the principles of Good Clinical Practices (GCP), for NexoBrid, EscharEx, and its pipeline product candidates.
Manufacturing
The company operates a manufacturing facility in Yavne, Israel. This facility allows it to manufacture sterile biopharmaceutical products, such as NexoBrid.
Research and development
The company research and development expenses were $8.9 million in the year ended December 31, 2024.
Marketing, Sales and Distribution
The company commercialize globally NexoBrid via multiple sales channels:
Europe
In Europe and Israel, the company sells NexoBrid, primarily through its own sales force consisting of a sales and marketing team of specialized and knowledgeable sales representatives in Europe, focusing on leading burn centers and Key Opinion Leaders (KOL) management. The company has obtained national reimbursement for NexoBrid in Belgium, Italy, and Greece and it continues to locally execute its market access strategy for most of Europe to obtain procurement by burn centers and hospitals as part of their budget, or under local, regional or national reimbursement, depending on the specific process required in each country. The company has established additional distribution channels through local partners to extend outreach in EU (France, Switzerland, Greece, Malta, Bulgaria and Cyprus,), where NexoBrid is already approved for marketing as part of the European marketing authorization. Additionally, the company expanded NexoBrid’s European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands and Luxembourg. In addition to receiving marketing authorization for NexoBrid in the EU, key opinion leaders in the burn care field worldwide are already aware of NexoBrid’s efficiency in removing eschar due to hundreds of scientific presentations and several award-winning abstracts at international and national conferences and about 120 peer-reviewed papers.
North America
Vericel License and Supply Agreements
On May 6, 2019, the company entered into exclusive license and supply agreements with Vericel to commercialize NexoBrid in all countries of North America (which it refers to as the Territory).
License Agreement.
The company entered into the Vericel License Agreement pursuant to which it granted Vericel an exclusive license, with the right to grant sublicenses, to develop and commercialize NexoBrid and any improvements of NexoBrid (the Licensed Product) in the Territory.
Supply Agreement
On May 6, 2019, concurrently with the company’s entry into the License Agreement, it entered into a supply agreement with Vericel (the Supply Agreement) pursuant to which the company is obligated to supply Vericel with NexoBrid for sale in the Territory on an exclusive basis for the first five years of the term of the Supply Agreement.
Pursuant to the Supply Agreement, the company will supply NexoBrid to Vericel based on Vericel’s fixed orders on a unit price basis. After a specified period, the unit price, on an annual basis, may be increased based on the United States Producer Price Index for Chemical Manufacturing published by the Bureau of Labor Statistics.
In September 2023, NexoBrid was launched in the U.S. by Vericel.
BARDA
Pursuant to the First BARDA Contract, Biomedical Advance Research and Developments Authority (BARDA) has completed the procurement of NexoBrid for emergency stockpile as part of the HHS mission to build national preparedness for public health medical emergencies. BARDA purchased inventory is being managed by MediWound under vendor managed inventory. Under its exclusive license and supply agreements with Vericel, the company will receive a double-digit royalty on any additional future BARDA purchases of NexoBrid.
Other International Markets
In other international markets, the company sells NexoBrid through local distributors with which it has distribution agreements, focusing on Asia Pacific, EMEA and CEE. The company has signed local distribution agreements for distribution in India, Bangladesh, Sri Lanka, Japan, Australia, New-Zealand, Singapore Vietnam, Philippines, Taiwan and United Arab Emirates.
The company’s distributors in Russia, South Korea, Taiwan, Japan, India and the United Arab Emirates have obtained marketing authorization.
Intellectual Property
As of December 31, 2024, the company had been granted a total of 88 patents, of which 50 are in force and have 17 pending patent applications. The family of patents that covers NexoBrid specifically includes 13 granted patents worldwide that are in force. EscharEx is covered by 13 patents in force worldwide.
The main patents for the company’s proteolytic enzyme technology which underlies NexoBrid, EscharEx and its current pipeline product candidates have been issued in Europe, the United States and other international markets. Absent patent-term extensions, the NexoBrid patents are set to expire in 2025 and in 2029 in the United States. The NexoBrid patent in the United States that is set to expire in 2025 is about to be granted a 5-year Patent Term Extension. The NexoBrid patents issued in Europe and in other foreign jurisdictions are nominally set to expire in 2025. The patents relating to EscharEx will expire on January 30, 2037, absent any patent-term adjustment and/or extensions.
The company also relies on protection available under trademark laws, and it holds various registered trademarks, including MediWound, NexoBrid and EscharEx in various jurisdictions, including the United States, the EU and Israel.
Klein License Agreement
In September 2000, the company signed an exclusive license agreement, as amended in June 2007, with Mark Klein, a third party, for use of certain patents and intellectual property (the Klein License Agreement). Under the Klein License Agreement, it received an exclusive license to use the third party’s patents and intellectual property to develop, manufacture, market and commercialize NexoBrid and its pipeline product candidates for the treatment of burns and other wounds.
Government Legislation and Regulation
In addition to EU regulations, NexoBrid is marketed as a biologic product in the United States for eschar removal in patients with deep partial thickness and/or full thickness thermal burns and is therefore subject to various U.S. regulations. In the United States, the FDA regulates biologics under the Federal, Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act, and their respective implementation regulations.
Any biologic products for which the company receives FDA approvals are subject to pervasive continuing regulation by the U.S. Food and Drug Administration (FDA).
The company's first biopharmaceutical product, Nexobrid, has received in December 2022, an approval from the U.S. Food and Drug Administration (FDA) and marketing approval in each of India, Switzerland and Japan. In addition, it has a marketing authorization from the European Medicines Agency (EMA) and regulatory agencies in other international markets for removal of dead or damaged tissue, known as eschar, in adults with deep partial and/or full-thickness thermal burns.
History
MediWound Ltd. was founded in 2000. The company was incorporated in 2000.
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