— VHA implanted in nearly 500 patients with over 1,000 patient-years of follow-up to date, for the treatment of peripheral arterial disease, arteriovenous access for hemodialysis and trauma –
— Immediately available HAV, if approved, would represent significant and innovative advances in vascular repair and replacement conduits —
DURHAM, NC, June 29, 2022 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues at commercial scale , announced today that an analysis of the potential of the human acellular vessel (HAV) to expand vascular surgical treatment options has been published online in the Journal of the American Medical Association (JAMA) complementary review Operation.
Humacyte’s HAVs are replacement vessels designed to be durable, infection-resistant, and ready-to-use to address long-standing limitations in vascular tissue repair and replacement. VHA is currently being evaluated in late-stage clinical trials in vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease (PAD). To date, VHA has been implanted in nearly 500 patients, with more than 1,000 patient-years of follow-up in seven clinical trials, including 31 cases conducted under an authorized Expanded Access Program (EAP) of the United States Food and Drug Administration (FDA).
The JAMA surgery The manuscript, titled “The Human Acellular Vessel (HAV) for Vascular Reconstruction and Bypass,” reviews the clinical need for improved options for vascular reconstruction and bypass conduits, and the potential advantages of HAV over existing approaches. .
“The current standard of care for vascular reconstruction or bypass procedures requiring a replacement vessel often involves autologous vein harvesting, which is associated with wound complications, or the use of a synthetic vascular conduit, which demonstrated unfavorable conformance to native vessels,” said Todd E. Rasmussen, MD, FACS, (Col, ret. USAF MC), manuscript co-author, professor, and vice chair for education in the Department of Surgery. and Senior Associate Consultant in the Division of Vascular and Endovascular Surgery at Mayo Clinic. “While there have been tremendous advances in vascular surgery over the past few decades, HAV represents the first recent innovation of a biological vascular conduit that has the potential to significantly impact the clinical care of diseases. vascular and trauma. Further clinical evaluation of the efficacy and durability of HAV is warranted and ongoing. Dr. Rasmussen has treated nearly 20 HAV patients through the EAP and through his leadership of ongoing clinical trials.
The JAMA Surgery The manuscript also highlights clinical data supporting the broad use of HAV in vascular surgery settings in the future. This includes a Phase 2 trial of HAV in patients with PAD, with no HAV-related infections, structural failures or amputations reported to date. Durability as a dialysis conduit has also been observed, with HAV tolerating and healing repeated needle sticks over time.
“Favorable data from multiple clinical trials and our surgical experience have indicated that HAV represents a promising alternative avenue for regenerative medicine with favorable biological properties, including durability and low risk of infection, with broad application,” said first author Alexis L. Lauria, MD, Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center in Bethesda, Md.
The results of the first case series of compassionate use of HAV for the treatment of critical limb ischemia were also recently published online in the Annals of Vascular Surgery. The manuscript, titled “Preliminary Experience with the Human Acellular Vessel: A Descriptive Case Series Detailing Early Use of a Bioengineered Blood Vessel for Arterial Repair,” reports early results of HAV implantation in eight patients with complex limb ischemia and limited vascular conduit options that may have otherwise faced amputation, under an FDA-cleared EAP. The VHA remained patent in five patients who received lower extremity bypasses at an average of 11.4 months (range 4-20 months). The findings were presented by Alexander Kersey, MD, of the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS).
“Inadequate blood flow can quickly deteriorate into a possible limb loss scenario without proper vascular conduit replacement to restore circulation,” Dr. Kersey said. “The case series demonstrated that VHA remained patented and infection-free and continued to work in patients with complex revascularization situations, further reinforcing the potential of VHA to expand limb salvage opportunities in vascular trauma and reconstruction. .”
“The JAMA surgery and Annals of Vascular Surgery These publications underscore the innovative nature of our bioengineered HAV, its potential advantages over current approaches, and the clinical advances we have made,” said Laura Niklason, MD, Ph.D., President and CEO of Humacyte. “We look forward to continuing to build on this solid set of data supporting the versatility and potential of HAV to improve clinical care that saves lives and limbs.”
HAV is an investigational product and has not been approved for sale by the FDA or any other international regulatory agency.
Human Acellular Vessels (HAV) are off-the-shelf, experimentally designed replacement vessels originally developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations of vascular tissue repair and replacement – it can be manufactured on a commercial scale, it eliminates the need to harvest a vessel from a patient, and clinical evidence suggests it is non-immunogenic and resistant to infection, and can grow into durable living tissue. VHA is currently being evaluated in two Phase 3 trials in arteriovenous access and one Phase 2/3 trial in vascular trauma, and has been used in nearly 500 patient implantations. Humacyte’s 6mm HAV for AV access to perform hemodialysis was the first product to receive Advanced Regenerative Medicine Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), and also received Fast Track designation from the FDA. HAV has received priority designation for the treatment of vascular trauma by the United States Secretary of Defense.
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue and organ systems designed to improve patient lives and transform practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. The initial opportunity for Humacyte, a human acellular vessel (HAV) portfolio, is currently in late-stage clinical trials targeting multiple vascular applications including vascular trauma repair, arteriovenous access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafting, pediatric cardiac surgery, treatment of type 1 diabetes, and multiple new cell and tissue applications. Humacyte’s 6mm HAV for arteriovenous (AV) access to perform hemodialysis was the first product candidate to receive Advanced Regenerative Medicine Therapy (RMAT) designation from the FDA, and also received the FDA Fast Track designation. HAV has received priority designation for the treatment of vascular trauma by the United States Secretary of Defense. For more information, visit www.Humacyte.com.