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

SurModics

19/01/2023 15:38

(Updates)
    ** Shares of medical device coatings maker Surmodics Inc
 SRDX.O  drop ~24% to $28.55
    ** Stock set for biggest daily pct fall since November 2010,
if losses hold
    ** SRDX says it received a letter from the U.S. FDA, in
which the agency "indicated" company's premarket application for
a 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
    ** The information identified by FDA will require additional
testing and analysis to put the application in approvable form,
according to company
    ** Letter did not question human clinical data submitted nor
request any further human clinical data - company
    ** Surmodics shares fell ~32% in the past 12 months
 (Reporting by Raghav Mahobe)
 ((Raghav.Mahobe@thomsonreuters.com;))