15 December 2022 - Alexis Bio today announced that realSKIN is the first live cell xenotransplant product to be designated as a regenerative medicine advanced therapy by the US FDA. 

The company's investigational therapy is currently under evaluation in a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of realSKIN to provide complete and durable wound closure from a single application, by promoting autologous skin regeneration of severe and extensive deep-partial and full-thickness thermal burn wounds requiring hospitalisation, surgical excision, and skin grafting for which auto-grafting is clinically indicated.

Read Alexis Bio press release