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MediWound confirms FDA approval of NexoBrid triggers $7.5M milestone

MediWound (MDWD) announced that the U.S. Food and Drug Administration has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. "We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuriesWe appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement. We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S. This U.S. FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023," said Ofer Gonen, CEO of MediWound. NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. Vericel Corporation (VCEL) holds an exclusive license to commercialize NexoBrid in North America. MediWound will receive a $7.5M milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid, the company stated.

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