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Humacyte Announces Publication Highlighting the First Use of the Human Acellular Vessel (HAV™) as Arterial Bypass Conduit for Replacement of Infected Prosthetic Graft
-- Vanderbilt University Medical Center patient received the HAV under the U.S. Food and Drug Administration’s (FDA) Expanded Access Program (EAP) in April
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Vanderbilt University Medical Center patient received the HAV under the U.S. Food and Drug Administration’s (FDA) Expanded Access Program (EAP) in April 2019 -- -- After replacement, the patient resumed regular physical activity with no signs of infection of the HAV implant observed -- -- Published in Journal of Vascular Surgery: Cases, Innovations and Techniques -- -- HAV used in 20 EAP cases to date, for treatment of severe vascular disease and trauma -- DURHAM, N.C., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that results from a case study of a patient who received the human acellular vessel (HAV) as a replacement for an infected synthetic iliofemoral bypass graft have been published online in the Journal of Vascular Surgery: Cases, Innovations and Techniques (JVSCIT). The manuscript, entitled “Surgical management of an infected external iliac artery interposition graft with a bioengineered human acellular vessel,” reports the first use of the HAV in the treatment of a patient with an infected prosthetic vascular graft, a procedure performed in April 2019 under an expanded access use authorized by the FDA. The case report describes a 42-year-old female patient with a medical history of a right external iliac artery endofibrosis (EIAE) who had ipsilateral claudication and a persistently infected synthetic iliofemoral bypass graft replaced with a bioengineered HAV. Twenty-two months post-implantation, the patient demonstrated significant clinical improvement and had resumed regular physical activity. In addition, no signs of infection of the HAV implant have been observed. The patient’s story can be viewed here: https://www.youtube.com/watch?v=-bRPYKzO5B8. “Very few techniques exist that provide durable long-term or permanent solutions to vascular reconstruction,” said Thomas Naslund, M.D., of Vanderbilt University Medical Center and co-author on the case study. “The potential of the investigational HAV to populate with the patient's own cells and become a part of the patient's own DNA and own tissue, and thereby be durable over time and free from complications that threaten other types of conduits, warrants further evaluation as a replacement for infected sy...