Surmodics falls on FDA's response for vascular disease device application

SurModics

19/01/2023 13:12

** Shares of medical device coatings maker Surmodics Inc
 SRDX.O  down 13.3% to $32.38 premarket
    ** Co says it received a letter from the U.S. FDA in which
the agency "indicated" co's premarket application for peripheral
artery disease device was not currently approvable
    ** The experimental device, SurVeil Drug-Coated Balloon, is
being evaluated as a treatment for peripheral artery disease,
which causes a reduction of blood flow through arteries 
    ** FDA's letter stated that certain information within two
categories, biocompatibility and labeling, must be added by an
amendment to the company's application - SRDX
    ** Adds that the information identified by FDA would require
additional testing and analysis to put the application in
approvable form
    ** Letter did not question human clinical data submitted nor
request any further human clinical data, co says 
    ** Surmodics shares down ~17% in the past 12 months 
 (Reporting by Raghav Mahobe)
 ((Raghav.Mahobe@thomsonreuters.com;))