Titan Medical down on delay in surgical system trial application

Conavi Medical

11/11/2021 17:33

** U.S.-listed shares of Canadian medical device maker
 TMDI.O  down 24.5% to $1.23
    ** Co says it requires "additional time and work" before
filing an IDE application with U.S. FDA for its Enos surgical
system  urn:newsml:reuters.com:*:nBw5p4Q0Ya
    ** An IDE is a regulatory submission that permits clinical
investigation of devices
    ** Co says decision based on recent discussions with FDA,
manufacturer on supply chain of components, and product and
software testing
    ** ** TMDI now expects to file application in Q1 of 2023,
nearly a year later than earlier forecast of Q1 of 2022, and
anticipates receiving a response in first half of 2023
    ** Expects to begin clinical study in 2024 and commercial
launch of Enos system is currently expected in early 2025

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))