InVivo Therapeutics soars as its preclinical module gets FDA's nod

InVivo Therapeutics Holdings

13/07/2021 17:11

** Shares of medical equipment maker  NVIV.O  up as much as
13.76% at $0.77 
    ** FDA approves co's preclinical module, first of the three
individual modules, for its humanitarian device exemption (HDE)
application  urn:newsml:reuters.com:*:nBwb4xFsma
    ** HDE enables the development of medical devices intended
to treat or diagnose a disease or condition affecting fewer than
4,000 people a year in the United States. To receive approval, a
company must demonstrate the safety and probable benefit of the
device
    ** Acceptance of the module indicates that FDA has completed
its review of this module of the HDE and has no outstanding
questions- NVIV
    ** Co says review of the remaining two HDE modules, when
complete, will be required prior to a final approval decision
    ** Stock was down ~5% YTD, as of last close
    

 (Reporting by Rithika Krishna in Bengaluru)
 ((Rithika.Krishna@thomsonreuters.com;))