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FDA granted full approval for SYMVESS™ (acellular tissue engineered vessel-tyod). This approval authorizes its use in adults as a vascular conduit for extremity arterial injuries requiring urgent revascularization to prevent imminent limb loss, particularly when autologous vein grafts are not feasible.
– SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair –
– In clinical testing SYMVESS was observed to have high rates of patency, or blood flow,
and low rates of amputation and infection –
– Highly experienced sales team already recruited and trained in preparation for commercial launch –
DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has granted a full approval for SYMVESS (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members.” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “SYMVESS approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of SYMVESS, and we have recruited and trained a terrific team to execute on our sales and marketing missions.”
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