"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."
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 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.
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.
Jan. 15, 2022 - On Saturday, January 15, 2022, Paul Holzer and Jon 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 who was injured in the line of duty while rescuing residents from a building fire on November 6, 2021. Learn More »
From Pig to Patient: XenoTherapeutics Completes First Cohort of Patients in First US Clinical Trial of Live-Cell Xenotransplant; Evidence of Safety and Efficacy Allows for Accelerated Patient Enrollment
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. Learn More »
April 4, 2019 - XenoTherapeutics, 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. Learn More »
XenoTherapeutics Wins ABA’s Best Bioengineering Paper Award for Research on Xeno-Skin®, a Novel Xenotransplantation Treatment for Severe Burns
XenoTherapeutics to Start First Human Trial of
Xeno-Skin®, a Novel Xenotransplantation Treatment for Severe Burns
December 8, 2018 - XenoTherapeutics, 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 preparations to enroll patients for a first-in-human clinical study of Xeno-Skin® at Massachusetts General Hospital (MGH) by the end of 2018. Learn More »