IceCure falls as FDA denies de novo request for breast cancer treatment system

Icecure Medical

20/09/2023 13:04

** Shares of Israel-based medtech co IceCure Medical Ltd
 ICCM.O  fall 42% to 52 cents before the bell - among top pct
losers across US exchanges
    ** Co says the U.S. FDA has denied its de novo
classification request for its breast cancer treatment system
    ** Adds this has no effect on the system's FDA cleared
authorization for other indications in the U.S.; says patients
in the U.S. continue to have access to the system, ProSense, for
those treatments
    ** De Novo classification is a risk-based classification
process, which provides a marketing pathway to classify novel
medical devices
     ** Co continues its study of the system which is expected
to complete during Q1 2024
    ** ProSense applies liquid-nitrogen-based cryoablation
therapy, a process that uses extreme cold for the treatment of
tumors
    ** Up to last close, stock down ~42% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))