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MediWound Expands Global Reach with Marketing Approval of NexoBrid® in Australia
Globenewswire· 2025-09-25 11:30
Core Insights - MediWound has received marketing authorization for NexoBrid from Australia's Therapeutic Goods Administration (TGA), allowing its use for both adults and children with deep partial- and full-thickness thermal burns [1][2] - NexoBrid is now authorized in 45 countries, establishing it as a new standard of care in burn management, with a commercial launch expected in Australia in Q4 2025 [2][3] - The company is expanding its manufacturing capabilities, which are on track for completion by the end of 2025, to meet global demand for NexoBrid [2][3] Product Overview - NexoBrid is a topically administered biological orphan drug designed for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns, preserving viable tissue while removing non-viable tissue [4] - The product is already approved in over 40 countries, including the United States, European Union, and Japan [4][5] Company Background - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with NexoBrid being its FDA-approved product [5] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5] Market Expansion - The TGA approval of NexoBrid is seen as a significant step in improving access to innovative burn care solutions in Australia and opens opportunities for expansion into the broader Asia-Pacific region [3] - Balance Medical, MediWound's exclusive partner in Australia, is expected to initiate the commercial launch of NexoBrid in the fourth quarter of 2025 [2][3]