December 29, 2022

NexoBrid (anacaulase-bcdb) approved for the Treatment of Severe Thermal Burns in Adults

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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. NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns and 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% of the body surface area. A second application may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.

The safety and effectiveness of NexoBrid have not been established for treatment of:

• Chemical or electrical burns
• Burns on the face, perineum, or genitalia
• Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive
vascular disease
• Circumferential burns
• Burns in patients with significant cardiopulmonary disease, including inhalation injury

NexoBrid is not recommended for wounds contaminated with radioactive and other hazardous
substances to avoid unforeseeable reactions with the product and an increased risk of spreading the
noxious substance.

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