Australia's Hydrix hits over 9-year low after failing to get TGA nod

Hydrix

15/02/2023 04:00

** Shares of medical devices technology co Hydrix Ltd
 HYD.AX  slide as much as 23.1% to A$0.045, their lowest since
Nov. 11, 2013
    ** Co says it has been advised by the Therapeutic Goods
Administration (TGA) that its current application for regulatory
approval to distribute the Angel Medical Systems' Guardian in
Australia is not going to be accepted
    ** Guardian is a real-time heart attack alert system
    ** Says TGA granted it until time until Feb. 27 to co to
consider its response 
    ** Adds that co is seeking clarification from TGA, and will
evaluate alternate pathways and options available to seek
approval
    ** More than 2.6 mln shares change hands, 23.4 times the
30-day average of 112,056 shares
    ** As of last close, stock up 14.7% this year
 (Reporting by Himanshi Akhand in Bengaluru)
 ((Himanshi.Akhand@thomsonreuters.com;))