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Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma



April 18, 2023


  • Results published in Journal of Trauma and Acute Care Surgery
  • Company also provides update on enrollment progress in Phase 2/3 vascular trauma trial

 

DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery comparing the use of its Human Acellular Vessel (HAV) to expanded polytetrafluorethylene (ePTFE) grafts for vascular repair following arterial trauma. In the preclinical study the HAV performed better than ePTFE on multiple indices.

 

In this comparative preclinical study, 36 pigs were randomly assigned to treatment groups receiving either the HAV or an ePTFE graft to reconstruct a severed iliac artery after vascular trauma. The animals were monitored for 28 days and routinely assessed for recovery of hind limb function, graft patency, and circulating biochemical markers of tissue ischemia and reperfusion injury. At the conclusion of the study, the HAV and ePTFE implants were removed and histologically evaluated for host cellular response.

 

The data observed in this preclinical study indicate that the HAV performed better than ePTFE on multiple indices, including recovery of limb function after six hours of ischemia and conduit patency. In addition, the HAV showed no incidence of infection, degradation, aneurysm or mechanical failure. Host recellularization of the HAV conduits was observed to be greater than that of ePTFE grafts.

 

If not treated quickly and correctly, vascular trauma can lead to amputation or death. The standard practice for vascular repair requires harvesting and repurposing a section of vein from another limb, a process that can be time-consuming, painful, and may lead to failure or other complications for the patient. Alternatively, synthetic grafts like ePTFE have been shown to lack positive host responses and recellularization, making ePTFE more prone to infection and hence often unsuitable for contaminated wounds.

 

“We believe the results of this study underscore the potential of the HAV to save the lives and limbs of those suffering from vascular injury and peripheral tissue ischemia,” said Rob Kirkton, Ph.D., Director of New Product Development at Humacyte and lead author of the publication.

 

Humacyte’s HAV is a universally implantable and an infection-resistant vascular conduit that is designed to avoid the difficulties and increased recovery time associated with harvesting a vein. The HAV is also designed to resist infection, making it potentially useful in contaminated wound beds or other settings at high risk for infection. Additionally, the HAV is intended to be ready off-the-shelf and available whenever surgeons need it, saving valuable time and potentially improving patient outcomes in cases requiring urgent vascular repair for both civilians and military personnel.

 

The publication of this preclinical study comes as Humacyte nears the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of vascular trauma. The primary efficacy assessment of the HAV will be based on a 30-day patency in 50 patients from the V005 trial who have vascular trauma of the extremity (excluding torso injuries and iatrogenic trauma patients). Currently, a total of 65 patients have received the HAV in the V005 trial, including 48 patients comprising the primary endpoint population. The Company plans to enroll approximately four more patients in the trial to support a Biologics License Application (BLA) filing for accelerated approval with the U.S. Food and Drug Administration (FDA). In addition, the product candidate is also being used under a humanitarian program for which 18 vascular trauma patients wounded in the ongoing conflict in Ukraine have been treated with the HAV. The HAV has accumulated over 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for hemodialysis, and peripheral artery disease.

 

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.