Neovasc Receives Approval to Proceed with Phase 2 of TIARA-II Study from Clinical Regulators in Germany and the UK
Neovasc Inc. - Common Shares (NVCN)
Last neovasc inc. - common shares earnings: 3/30 04:08 pm
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Source: PR Newswire
Successfully completed all Phase 1 requirements of TIARA-IINASDAQ, TSX: NVCN VANCOUVER, Jan 29, 2019 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that it has completed the Phase 1 requirements of the TIARA-II study required by the bi-phasic study design in both Germany and the United Kingdom and has received approval to proceed with Phase 2 of the TIARA-II study for its Tiara™ transcatheter mitral valve replacement device (the "Tiara"). This approval comes following Clinical Events Committee adjudication of adverse events, Data and Safety Monitoring Board review of the data, and Governmental regulatory and ethics committees reviews of the interim clinical report provided for 20 implanted subjects. This approval will allow the TIARA-II st
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