Humacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel™ (HAV™)
The publication, titled Biological Mechanisms of Infection Resistance in Tissue Engineered Blood Vessels Compared to Synthetic ePTFE Grafts, combined histological evaluation of the HAV and ePTFE explants from both preclinical and clinical studies as well as in vitro experiments assessing the viability and function of human neutrophils on these materials. Neutrophils are a critical cell type for host defense against infection. Data analyzed from a comparative clinical trial demonstrated that the HAV had a significantly lower infection rate than ePTFE grafts. A biological rationale for this finding was then shown through explant histopathology and cell experiments which demonstrated that the HAV, but not ePTFE grafts, supported neutrophil viability and function. These results continue to build upon the functional benefits of HAV biocompatibility which has been previously observed to permit adaptive host vascular remodeling and now host immune activity for infection resistance.
“This study further supports that the HAV has the potential to serve as a breakthrough treatment to save the lives and limbs of patients suffering from a wide range of medical conditions, from trauma to peripheral artery disease,” said Dr.
Vascular graft infection represents a significant clinical and economic burden in
The HAV has accumulated over 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, 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.
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; the outcome of our ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial, including determination of trial size, and the scope of any approved indication for our HAVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that
Source: Humacyte, Inc.