Xenograft Gains Regenerative Medicine Advanced Therapy Status

Alexis Bio and Xeno Therapeutics’ realSKIN, a xenograft cultured from live porcine skin tissue, has become the first non-autologous tissue to win the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation.

The tissue, intended for temporary wound closure, promotes skin regeneration for patients with severe burn wounds who need surgical excision and skin-grafting.

The xenograft functions as a skin barrier during healing, providing protection against infection and preventing fluid loss while the epidermis beneath it heals naturally. realSKIN obviates the need for an allograft — especially important in patients with extensive injuries to large areas of the body.

Supported by positive phase 1/2 data, the RMAT designation gives the sponsor earlier and increased interactions with the FDA, including talks about whether the product might qualify for priority review or accelerated approval.