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MediWound Ltd., a fully-integrated Israel based biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, has announced receipt of authorization from the Ministry of Health in South Korea to market and distribute NexoBrid for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns.
BL&H Co., Ltd., MediWound’s exclusive distribution partner in South Korea, received the marketing authorization and intends to launch NexoBrid in South Korea in the second half of 2018.
This regulatory approval builds upon NexoBrid’s marketing authorization from the European Medicines Agency (EMA) for the same indication and validates MediWound’s strategy of using the EMA approved registration file for seeking approval in international markets.
NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues.
