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Laura Niklason, a bioengineer and anesthesiologist from Duke University, founded Humacyte, a company focused on regenerative medicine, which aims to repair or replace body parts with lab-grown tissues.
Recently, the FDA approved the company’s first product, a lab-grown blood vessel that can be used in surgeries to restore blood flow in trauma victims or those needing coronary bypasses. This approval marks a significant step forward for Humacyte and the field of regenerative medicine, which has faced challenges in turning experimental science into approved treatments.
The product, named Symvess, was developed after several iterations and rigorous testing to ensure its safety and consistent manufacturing. The approval was based on a study involving 54 patients with traumatic limb injuries, showing that the blood vessels restored blood flow in most patients, with 67% maintaining it after 30 days. However, some patients still required amputations, though Humacyte believes its vessels have lower amputation rates compared to synthetic plastic-based vessels.
Humacyte’s vessels are created by molding a biodegradable polymer into the shape of an artery and covering it with vascular cells, which are grown in a bioreactor for two months to simulate blood flow. Afterward, the cells are stripped away, leaving behind a collagen matrix that is implanted into the patient. This acellular approach is designed to reduce the chances of immune rejection by the patient’s body.
The vessels will be marketed to trauma centers that handle severe injuries like gunshot wounds or car accidents, where using a patient’s own veins is not an option. The product’s availability will initially be limited to major trauma centers, which are concentrated in urban areas. Humacyte has already prepared for commercialization with a small salesforce.
While Humacyte has not disclosed the cost of the vessels, it is expected that they will be priced higher than traditional plastic vessels. The company anticipates strong interest from the surgical community due to the innovative nature of the product. However, like any new product, there may be challenges related to its premium price.
The vessels carry some safety risks, including potential thrombosis, pain, or rupture, and the possibility of infectious disease transmission, although Humacyte believes they pose a lower infection risk than plastic vessels. Despite these concerns, the approval of Symvess is a milestone for regenerative medicine and offers a promising alternative for patients in need of blood vessel replacements.
