US FDA extends review of Humacyte's blood vessel implant

[August 12, 2024]  (Reuters) - Humacyte said on Friday the U.S. health regulator has extended review of the company's implant that can act as a replacement for an injured or damaged blood vessel, sending its shares down more than 15% after the bell.

The Food and Drug Administration needed additional time to complete its review and did not disclose a new decision date, the company said. The agency was set to announce its decision on Aug. 10.

The implant, known as Human Acellular Vessel (HAV), is made of biologically engineered human tissue that is universally implantable and resists the possibility of infection.

HAV can be used to treat patients with injured blood vessels who do not have a synthetic blood vessel prescribed to them or cannot use a healthy vein from the body as replacement.

The company estimates that 10,000 to 30,000 patients get affected with blood vessel injuries annually in the United States.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Its application to the FDA was based on a mid- to late-stage study, where HAV showed higher rates of blood flow and lower rates of infection compared to synthetic implants.

(Reporting by Christy Santhosh; Editing by Shilpi Majumdar)

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