Mallinckrodt earns FDA nod for regenerative skin therapy for burns
Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. The company said regenerative skin tissue therapy could lessen or eliminate the requirement of autografting of healthy skin to treat burn wounds.
Stratagraft, which includes human keratinocytes and dermal fibroblasts in an engineered, bilayer construct, is designed to mimic natural human skin, both its inner dermis-like and outer epidermis-like layers. It comprises a living dermal matrix containing dermal fibroblasts and is overlaid with human epidermal cells. Designed for topical application, it c...
