The FY2026 National Defense Authorization Act (NDAA), enacted in December 2025, stated in report language that DoD should "integrate FDA-approved breakthrough vascular repair technologies in traumatic extremity arterial injury repair, providing an off-the-shelf, biologically active vascular conduit when autologous vein harvesting is not feasible." In doing so, lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered vessels to save life and limb on the battlefield. Humacyte is grateful to see Congress express even greater support for this medical innovation by designating appropriated funds to advance the goal of making this groundbreaking technology available to service members.
Humacyte's Symvess® is the only human-derived bioengineered blood vessel approved by the U.S. Food and Drug Administration (FDA).
"America's brave men and women in uniform deserve the very best care we can provide," said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. "That's why, at Humacyte, we are grateful to Congress for directing targeted federal resources for the Department of Defense to acquire biologic vascular repair technology that can be used in combat to treat and repair traumatic vascular injuries in military personnel."
"This historic, first-of-its-kind federal investment will help ensure our soldiers continue to have access to cutting-edge treatments and state-of-the-art care whenever and wherever they need it," Niklason continued. "Our product, Symvess, has already been tested on the battlefield in Ukraine, where patients with gunshots, shrapnel, blasts, and accidents were treated as part of a humanitarian program. Sixteen patients from this program followed in a retrospective, observational study had 100% survival, zero amputations and zero conduit infections despite incurring serious wartime injuries. We look forward to working with leaders in our military and the Pentagon to ensure that American service personnel will have access to this same quality of care."
For uses other than the FDA approval in the extremity vascular trauma indication, Symvess is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
INDICATION
Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: GRAFT FAILURE
Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.
CONTRAINDICATIONS
DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.
WARNINGS AND PRECAUTIONS
Graft Rupture
Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture ...
