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PRESS RELEASES

U.S. FDA Designates Alexis Bio's realSKIN

as Regenerative Medicine Advanced Therapy

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UPPER VALLEY, N.H., December 15, 2022 - (BUSINESS WIRE)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 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.

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Source: WMUR 9 ABC

MANCHESTER, N.H. - Steve DesRuisseaux, the Manchester fire captain severely burned last November while rescuing residents in a fatal apartment building fire, will return to duty June 27, seven months after suffering second and third-degree burns over more than a third of his body.

 

DesRuisseaux became engulfed in flames during a flashover while rescuing a man from the second floor of the building, Manchester Fire Battalion Chief Dave Fleury said.

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January 15, 2022On Saturday, January 15, 2022, Paul W. Holzer and Jon W. Adkins, Co-Founders of XenoTherapeutics and Alexis Bio had the honor of attending a fundraising hockey game to support the Boston Firefighters Burn Foundation and Capt. Steve DesRuisseaux of the Manchester Fire Department was injured in the line of duty while rescuing residents from a building fire on November 6, 2021.

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November 5, 2020 - XenoTherapeutics, a clinical-stage cell and gene therapy company engineering immune-compatible cells, tissues, and organs, has completed the first of two patient cohorts in the company’s Phase I clinical trial of Xeno-Skin®. As a result, the U.S. Food and Drug Administration (FDA) has agreed to permit accelerated patient enrollment; patients may now enroll in the trial’s second cohort simultaneously. No adverse events or safety issues have been observed or reported to date; in all patients, Xeno-Skin® and the human skin comparator were indistinguishable at the time of autografting.

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April 4, 2019XenoTherapeutics, Inc., a regenerative medicine company specializing in xenotransplantation, received the Burke/Yannas Award for Best Bioengineering Paper today at the 51st conference of the American Burn Association for its research of Xeno-Skin®. Co-founders Paul Holzer, CEO, and Jon Adkins, COO, accepted the award on the company’s behalf.

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XenoTherapeutics to Start First Human Trial of

Xeno-Skin®, a Novel Xenotransplantation Treatment for Severe Burns

December 8, 2018XenoTherapeutics, a life science company whose mission is to solve the global shortage of organs and tissues for transplants, announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application (IND #18194) allowing clinical studies of Xeno-Skin® to be initiated. Xeno-Skin is a first-of-its-kind xenotransplantation product, designed to provide a safe temporary coverage mechanism for patients with severe burn wounds. The company is inactive in preparations to enroll patients for a first-in-human clinical study of Xeno-Skin® at Massachusetts General Hospital (MGH) by the end of 2018.

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PUBLICATIONS
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Abstract

UPPER VALLEY, N.H., January 17, 2023 - (Xenotransplantation Journal, Volume 29, Issue 6)Surgical intervention is required to successfully treat severe, large-gap (≥4 cm) peripheral nerve injuries. However, all existing treatments have shortcomings and an alternative to the use of autologous nerves is needed. Human and porcine nerves are physiologically similar, with comparable dimensions and architecture, presence and distribution of Schwann cells, and conserved features of the extracellular matrix (ECM). We report the repair of fully transected radial nerves in 10 Rhesus Macaques using viable, whole sciatic nerve from genetically engineered (GalT-KO), designated pathogen-free (DPF) porcine donors. This resulted in the regeneration of the transected nerve, and importantly, recovery of wrist extension function, distal muscle reinnervation, and recovery of nerve conduction velocities and compound muscle action potentials similar to autologous controls. We also demonstrate the absence of immune rejection, systemic porcine cell migration, and detectable residual porcine material. Our preliminary findings support the safety and efficacy of viable porcine nerve transplants, suggest the interchangeable therapeutic use of cross-species cells, and highlight the broader clinical potential of xenotransplantation.

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