Benzinga | Nov 16, 2021 07:39AM EST

Humacyte Presents Preclinical Results Of Small-Diameter HAV For Use As A BTT Shunt In Pediatric Heart Disease At American Heart Association's Scientific Sessions 2021

Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced positive results from a preclinical study of the small-diameter (3.5mm) HAV in a primate model simulating pediatric heart disease were presented at the American Heart Association's (AHA) Scientific Sessions 2021.

In this initial preclinical study, five non-immunosuppressed juvenile primates were surgically implanted with the 3.5mm diameter HAVs as modified Blalock-Taussig-Thomas shunts (mBTTs). The mBTT shunt operation is used as an initial stage of some pediatric surgical procedures to repair severe congenital heart defects. The 3.5mm HAVs were implanted into primates as mBTT shunts using standard surgical techniques, and the animals were studied for three to six months. Each of the HAVs remained patent during the study and exhibited repopulation with vascular cells. Two of the primates showed a stronger xenogeneic response to the human HAV material, an often expected outcome when implanting human tissue into animals, that resulted in mid-graft dilatations. The presentation was made at the AHA meeting by Humacyte Senior Preclinical Scientist Kevin Nash, Ph.D.

The 3.5mm diameter HAV has smaller product dimensions but is manufactured using a similar process as Humacyte's 6mm HAV system currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease. The production of the functional 3.5mm HAV is indicative of the potentially broad application of Humacyte's proprietary bioengineered tissue platform and manufacturing processes. Preclinical testing of the 3.5mm HAV is also underway in adult primates, and these preclinical studies are designed to support the future advancement of the HAV into adult human studies in Coronary Artery Bypass Grafting (CABG).

"Exploring the potential use of the HAV in cardiac surgical procedures represents a logical expansion of Humacyte's bioengineered vascular platform. Our HAVs are being tested in high-fidelity primate models of human heart disease, progressing our off-the-shelf regenerative medicine technology beyond the three vascular indications currently being evaluated in clinical trials," said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. "We have observed that HAVs repopulate with the patient's own cells to become living vascular tissues. This data demonstrates the potential of the small diameter HAV to remodel and regenerate in a similar way to become a living cardiovascular tissue, expanding the possibilities of the HAV platform, and potentially providing small diameter HAVs in the future as off-the-shelf options to improve outcomes in cardiac bypass surgery."