Humacyte, a biotechnology company specialising in bioengineered human tissues, has received full approval from the US Food and Drug Administration (FDA) for SYMVESS.
The product, which is a bioengineered vascular conduit, is designed for adult patients with extremity arterial injuries. It is particularly intended to be used in cases requiring immediate revascularisation to prevent limb loss when autologous vein grafts are not an option.
The approval follows Humacyte’s submission of a biologic licence application (BLA), which incorporated clinical data from its V005 pivotal Phase 2/3 trial. It also included real-world evidence from the use of SYMVESS in conflict settings, including wartime injuries in Ukraine.
The vascular conduit was used to treat traumatic injuries such as car accidents, gunshot wounds, and blasts across various settings. These included Level 1 Trauma Centres in the US and Israel, as well as hospitals near conflict zones in Ukraine.
SYMVESS, also known as ATEV, represents the first bioengineered human tissue product of its kind. This off-the-shelf arterial replacement eliminates the need to harvest veins from patients, a process that can be invasive and time-intensive.
By providing a readily available alternative, SYMVESS reduces surgical time and avoids complications associated with vein harvesting, enabling faster and potentially safer vascular repairs.
Data from clinical studies demonstrated promising outcomes for SYMVESS, with high rates of patency, which refers to maintained blood flow, and low rates of infection and amputation.
The findings confirmed SYMVESS’s efficacy in restoring blood flow in patients with severe injuries, positioning it as a viable alternative to autologous vein grafts.
Arterial trauma is a significant medical challenge in both civilian and military contexts. In civilian settings, such injuries often result from road accidents, industrial mishaps, and gun violence.
While autologous vein grafts are a preferred method for vascular repair, they are not always feasible, especially in cases where veins are damaged or unavailable. According to Humacyte, SYMVESS provides an alternative that can be implanted without additional surgical procedures, making it suitable for urgent cases where time is critical.
The FDA granted regenerative medicine advanced therapy (RMAT) designation for the SYMVESS trauma programme in May 2023. Humacyte filed its BLA in December 2023 and received priority review status from the FDA in February 2024.
