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MediWound Announces U.S. Commercial Availability of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
Orphan DrugDrug ApprovalPhase 3Clinical Result
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.
Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis. Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue. NexoBrid selectively targets eschar while preserving viable tissue, enabling more rapid and precise eschar removal, which may reduce the need for subsequent skin grafting and lessen patient trauma.
"We are thrilled to announce that NexoBrid is now commercially available in the United States through our partner, Vericel," stated Ofer Gonen, Chief Executive Officer of MediWound. "This pivotal milestone underscores our commitment to providing burn patients with immediate access to cutting-edge treatments and furthering our mission to minimize the need for surgical interventions."
Each year, approximately 40,000 people are hospitalized in the U.S. for burn-related injuries, and of those patients, more than 30,000 of them require some level of eschar removal, representing a $300 million addressable market for NexoBrid in the U.S. NexoBrid can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% Body Surface Area (TBSA). A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.
About NexoBrid
NexoBrid® (anacaulase-bcdb) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including in United States, European Union and Japan, where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
About MediWound Ltd.
MediWound Ltd. (Nasdaq: MDWD) 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.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
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