** Shares of surgical device maker Axogen AXGN.O fall 20% to $13 premarket
** The U.S. FDA has extended the review period for company's marketing application for Avance Nerve Graft — a surgically implanted device made from human nerve tissue used to repair damaged peripheral nerves — by three months to December 5
** The extension was prompted by Axogen's submission of substantial new manufacturing and facility information, which the FDA classified as a "major amendment"
** A major amendment designation allows the FDA additional time to review the new data under its guidelines
** Company is seeking approval to transition Avance Nerve Graft from a tissue product to a biologic
** Shares down 1.3% YTD, up to last close
(Reporting by Kamal Choudhury in Bengaluru)
((Kamal.Choudhury@thomsonreuters.com))
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