(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 20% 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 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.
(Reporting by Christy Santhosh; Editing by Shilpi Majumdar)
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