U.S. FDA Designates Alexis Bio's realSKIN™ as Regenerative Medicine Advanced Therapy


Alexis Bio, a private regenerative medicine company, today announced that realSKIN is the first live cell xenotransplant product to be designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (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 hospitalization, surgical excision, and skin grafting for which autografting is clinically indicated.

"We are very pleased the FDA has determined that realSKIN meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval," said Paul W. Holzer, Chief Executive Officer. "This provides the potential to bring a much-needed therapeutic option to patients even sooner than originally planned."

The RMAT designation allows for earlier and increased interactions with the FDA, including discussions of whether priority review and/or accelerated approval would be appropriate based on surrogate or intermediate endpoints that would be reasonably likely to predict long-term clinical benefit; or reliance upon data obtained from a meaningful number of sites. Once approved, when appropriate, the FDA can require various post-approval commitments.

"RMAT designation of realSKIN speaks to the strength of the clinical data generated during the prior clinical study," said Jon W. Adkins, CEO of Xeno Therapeutics Foundation "Alexis Bio and XenoTherapeutics are committed to developing advanced regenerative medicine therapies such as realSKIN for patients with serious conditions."

About Serious Thermal Burn Injuries
Deep partial-thickness and full-thickness burns are complex skin injuries requiring hospitalization, specialized treatment, and weeks if not months in which to recover. Traditionally, treatment for this serious burn condition has been limited to surgically removing more of a patient's own skin. realSKIN intends to demonstrate that a single application from a live biotherapeutic, non-human skin transplant can reduce and/or eliminate the need for this painful, expensive surgery.

About realSKIN
realSKIN is a non-autologous, living skin transplant with a five-year shelf life that is cleared by the FDA for investigational use to treat large surface severe burns with mixed depths that often include or progress to full-thickness burn indications. This burn product intends to provide definitive to durable wound closure within 90 days of a single application.

About Alexis Bio
Alexis Bio is an FDA Phase III clinical stage regenerative medicine company targeting live biotherapeutic solutions. The company is focused on off-the-shelf, acute regenerative medicine therapies that replace lost or damaged cells, tissues, proteins and organs.

About XenoTherapeutics Foundation
XenoTherapeutics Foundation a not-for-profit 501(c)(3) dedicated to advancing the science of xenotransplantation through education, research, development, and clinical testing toward a practical therapeutic use for the public benefit. XenoTherapeutics is the clinical sponsor for realSKIN (NCT03695939).

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