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MediWound Gets FDA Approval for NexoBrid Burns Treatment

MediWound

MediWound team (company pic)

MediWound Ltd., an Israeli biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, won approval from the FDA for the use of its NexoBird burns treatment, for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound will receive a $7.5 million milestone payment from Vericel Corporation which (holds an exclusive license to commercialize NexoBrid in North America) that was triggered by the FDA approval of NexoBrid.

NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. NexoBrid (anacaulase-bcdb) is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns.

The news comes after MediWound, in September, raised $30 million from the issuance of new shares. Mediwound is traded on the NASDAQ. The issue comes after the company’s shares fell by over 50% over the past year due to the ongoing financial crisis and global market drops.

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MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. The company says that its strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

“We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said MediWound CEO Ofer Gonen. “We 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 US.

“This US FDA approval of NexoBrid validates our enzymatic technology platform,” he added. “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.”

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