Drug intelligence / Profile preview

realSKIN

Development stage
Phase 3
Lead developer
Alexis Bio
Modality
Tissue Cells → Other Cell Types → Cell Therapies
Administration
Topical
01

Overview

realSKIN is a live cell xenotransplant product developed as an off-the-shelf regenerative medicine therapy for severe and extensive deep-partial and full-thickness thermal burn wounds. It is designed to provide complete and durable wound closure from a single application by promoting autologous skin regeneration, serving as an alternative to traditional autografting in patients requiring hospitalization, surgical excision, and skin grafting. realSKIN is the first live cell xenotransplant product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). The therapy is currently being evaluated in Phase 3 clinical trials for its safety, tolerability, and efficacy in burn wound management[6].

Brand names
realSKIN
Other names
realSKIN

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