Neovasc Announces Progress on COSIRA-II Clinical Trial

Provided By Globe Newswire

Last update: Nov 28, 2022

VANCOUVER and MINNEAPOLIS, Nov. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced an update on the COSIRA-II Clinical Trial (“Trial”) status. COSIRA-II is the U.S. Investigational Device Exemption (“IDE”) pivotal clinical trial the Company is executing for the Neovasc Reducer™ (“Reducer”) towards an approval decision for the device in the United States. The Trial will randomize approximately 380 patients at up to 50 sites in North America. To date, 55 patients have been enrolled at 17 active sites. The Company has undertaken several initiatives to further accelerate enrollment in the Trial, including machine learning technology, expanding the field clinical team, and initiating enrollments in Canada. Neovasc aims to complete randomization in the first half of 2024.