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Investing.com -- Anteris Technologies Global Corp. (NASDAQ:AVR) stock surged 87% in after-hours trading Monday following the announcement that the company has enrolled and successfully treated the first patients in its global pivotal trial for the DurAVR® Transcatheter Heart Valve (THV).
The procedures, part of the company’s PARADIGM Trial for patients with severe calcific aortic stenosis, were performed by Prof. Dr. Ole De Backer at Copenhagen University Hospital in Denmark. The trial aims to provide comparative evidence across all surgical risk groups for the company’s heart valve technology.
"With the first patients now randomized in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR® THV toward commercialisation, expanding treatment options for aortic stenosis patients," said Anteris Chief Medical Officer, Chris Meduri, M.D.
The PARADIGM Trial builds on Anteris’ existing clinical data from 130 patients previously treated with the DurAVR® THV system, including first-time aortic stenosis cases, valve-in-valve patients, and complex anatomies such as bicuspid aortic valve patients.
The company plans to expand the trial to additional sites across the United States, Europe, and Canada. Management expects strong investigator interest to support efficient recruitment and timely advancement of the study.
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