Regenerative Medicine Firm Humacyte's Bioengineered Tissue Shows Promise In Trauma Injuries

Humacyte Inc HUMA released topline results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair, showing that the HAV had higher rates of patency and lower rates of amputation and infection than historic synthetic graft benchmarks.

Humacyte plans to file a Biologics License Application for vascular trauma with the FDA during Q4 of 2023.

The V005 trial was a single-arm study conducted in the U.S. and Israel in patients with arterial injuries resulting from gunshots, workplace injuries, car accidents, or other traumatic events. 

Patients enrolled in the 69-subject study did not have the standard of care, saphenous vein, available to use as a bypass graft. 

The principal means of evaluation was comparability of secondary patency (blood flow) at 30 days, with primary patency (blood flow without intervention) also evaluated. 

Secondary comparisons comprised improvement in rates of amputation and rates of infection at 30 days. 

The principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2% for the extremity patients (89.9% for total patients) compared to 81.1% historically reported for synthetic grafts. 

Primary patency for total HAV and extremity patients was 81.2% and 84.3%, respectively. 

However, no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications.

For the secondary comparison of amputation rates, the HAV improved with a rate of 9.8% for extremity patients (10.1% for total patients) compared to 20.6% historically reported for synthetic grafts. 

For the secondary comparison of infection rate, the HAV improved, with a rate of 2.0% for the extremity patients (2.9% for the total patients) compared to 8.9% historically reported for synthetic grafts. 

There were no unexpected safety signals for the HAV in this study. 

Price Action: HUMA shares are up 8.11% at $4.00 on the last check Tuesday.