Key points from article :
Humacyte's Human Acellular Vessel (HAV) outperformed synthetic grafts in patency, amputation and infection rates in a phase 2/3 trial.
The HAVs are bioengineered, regenerative human tissues that could be used off-the-shelf to treat traumatic injuries.
The trial enrolled 69 patients in the US and Israel who had arterial injuries caused by gunshots, workplace injuries, car accidents and other traumatic events.
After 30 days, secondary patency rates reached 90.2% for the extremity injury group and just under 90% for the total participant pool.
Amputation rates were 10% for both the extremity-only and total study groups, compared to 20.6% in the synthetic graft benchmark data.
The company aims to submit a Biologics License Application (BLA) to the FDA for the use of HAVs in extremity vascular repair following traumatic injuries.