Clinical-stage biotechnology platform company Humacyte has shared results from a year-old humanitarian programme in Ukraine assessing the use of its regenerative vascular implant.
The Human Acellular Vessel (HAV) device is designed to help surgeons save lives and limbs by providing a universal implantable, bioengineered human vessel. The regenerative medicine product, lab-grown from human cells, holds the potential to replace current vascular replacement techniques and has been implemented in five Ukrainian frontline hospitals since June 2022.
Used to treat war injuries from gunshots, shrapnel and blasts, the HAV can save surgeons a patient’s time. To date the product has been used to treat 19 patients with vascular injuries and has demonstrated a high success rate. The results showed that there was a 100% limb salvage rate and a 100% patients survival rate after 30 days of treatment with no cases of infection of the HAV.
The clinical results from the year long humanitarian program were presented to the Military Health System Research Symposium (MHSRS) demonstrating its success on the frontlines. The results will also be used in Humacyte’s Biologics License Application (BLA) to the FDA, scheduled for the fourth quarter of 2023.
Speaking on the clinical results Laura Niklason, CEO of Humacyte said: “The HAV demonstrates enormous promise for treating critical injuries, both in overseas conflicts and civilian settings here at home.”
She added: “We remain dedicated to partnering with healthcare providers and regulatory authorities to make this ground breaking technology accessible to the patients and surgeons who need it most.”
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Humacyte’s existing manufacturing facilities has the capabilities to commercially produce the HAV device but has not yet received approval for sale by the any regulatory body including the FDA.
On the 26 of July Humacyte announced the completion of enrolment of its Phase 2/3 vascular trauma trial (V005) a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centres in the US and Israel.