Shares of biotechnology firm Humacyte, Inc. (HUMA) skyrocketed by a staggering 52.87% in Friday's pre-market trading session. This massive surge came after the company announced late on Thursday that the U.S. Food and Drug Administration (FDA) has granted full approval for its bioengineered human tissue product SYMVESS (acellular tissue engineered vessel-tyod).
The FDA approval allows SYMVESS to be used in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when an autologous vein graft is not feasible. This marks a significant milestone for Humacyte and the field of regenerative medicine.
SYMVESS is a first-of-its-kind, off-the-shelf implantable bioengineered human tissue that can serve as a vascular conduit for arterial replacement and repair. In clinical testing, SYMVESS demonstrated high rates of blood flow patency and low rates of complications such as amputation and infection when used for treating various traumatic arterial injuries like gunshot wounds, car accidents, and blast injuries.
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