Neovasc (NVCN) Receives Approval to Initiate TIARA II CE Mark Study in Italy

November 28, 2016 7:03 AM EST
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Neovasc Inc. (NASDAQ: NVCN) received both regulatory and ethics committee approval to initiate the Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA II) in Italy. TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara™ Transcatheter Mitral Valve with the Tiara™ Transapical Delivery System (Tiara™).

With these critical approvals now in place, it is expected that the first Italian TIARA II clinical study site will be initiated before year end, with first enrollment anticipated early in the new year. Approvals in additional geographies are expected in the first quarter of 2017.

"We have been very encouraged by the results to date with the Tiara device," stated Alexei Marko, Neovasc CEO. "Tiara has been successfully implanted in a wide range of patients including those with prosthetic aortic valves in place (both tissue and mechanical valves) and those with prior mitral valve surgical repairs, including mitral rings. With this approval, we look forward to beginning our CE mark study which offers a less invasive treatment option for patients determined to be high risk for surgery, suffering from severe MR, and to eventually have Tiara available as a treatment option for clinical use to treat this devastating disease."

It is expected that data from this study will be used to file for CE Mark approval for Tiara™. CE Mark is the European Union (EU) regulatory approval to commercialize a medical device. Receiving the CE Mark demonstrates that a product has been assessed by the EU authorities and conforms to the European essential requirements for safety and performance.



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