US FDA extends review of Humacyte's blood vessel implant (updated)

Humacyte

09/08/2024 21:24

(Adds details throughout)
       Aug 9 (Reuters) - Humacyte  HUMA.O  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)
 ((Christy.Santhosh@thomsonreuters.com))