Humacyte Secures FDA Approval for SYMVESS™ in Treating Vascular Trauma

Humacyte, Inc., a leading biotechnology platform firm, has received full approval from the U.S. Food and Drug Administration (FDA) for its groundbreaking product, SYMVESS. This acellular tissue-engineered vessel is designed to serve as a universally implantable vascular conduit for adults facing extremity arterial injuries that necessitate urgent revascularization to prevent limb loss, especially when autologous vein grafts are not feasible.

SYMVESS represents a significant innovation in the treatment of arterial injuries, leveraging Humacyte's cutting-edge bioengineering technology. With its introduction, patients who have suffered arterial injuries now have access to a new, transformative treatment option that promises high rates of patency and lower incidences of amputation and infection.

The approval of SYMVESS marks a pivotal moment for Humacyte and the broader field of regenerative medicine. This development underscores the company’s commitment to advancing bioengineering solutions and addressing clinical needs that have seen little innovation for decades. Humacyte is poised to launch SYMVESS commercially, supported by a highly skilled sales team ready to bring this product to the market.

Clinical experts have hailed SYMVESS as a technological breakthrough that stands to revolutionize trauma care. Dr. Charles J. Fox of the University of Maryland Capital Region, who participated in the V005 clinical trial, praised the product for its infection resistance and ability to integrate into native arteries. This innovation is expected to significantly enhance the quality of trauma care worldwide.

SYMVESS, known for its availability and ease of use, eliminates the need for additional surgical procedures to harvest veins from already-injured patients. Its off-the-shelf availability makes it an efficient solution, reducing the time required to restore blood flow after an injury. Clinical studies of SYMVESS, including the pivotal V005 Phase 2/3 trial and real-world applications in conflict zones such as Ukraine, have demonstrated its effectiveness in treating various traumatic injuries. Notably, the product has been successfully used in severe cases resulting from accidents, gunshot wounds, and other forms of trauma, both in the U.S. and internationally.

The FDA’s approval process, which concluded after a thorough review, also highlights the strategic advancements made by Humacyte. The company's Biologic License Application was submitted in December 2023, with the FDA granting a Priority Review earlier in February 2024. This thorough evaluation reflects the potential impact SYMVESS could have on improving outcomes for patients with complex vascular injuries.

SYMVESS is specifically indicated for use in adults as a vascular conduit when rapid revascularization is critical to avoid imminent limb loss, and when autologous vein grafts are not an option. Despite the promising benefits, healthcare providers and patients are advised to be aware of the potential risks associated with SYMVESS, such as graft rupture and anastomotic failure, as well as the need for ongoing antiplatelet therapy to prevent thrombosis.

Humacyte’s achievement in securing FDA approval for SYMVESS underscores its dedication to developing bioengineered human tissues that can transform medical practice and improve patient outcomes. With several other products in late-stage clinical trials, including those targeting vascular trauma repair and peripheral artery disease, Humacyte continues to lead in the innovation of tissue-engineered medical solutions.