Neovasc (NSDQ:NVCN) said today that it won regulatory and ethics committee approval for a clinical trial of its Tiara replacement heart valve in Italy that it plans to use to back a bid for CE Mark approval in the European Union.
Vancouver-based Neovasc said the 115-patient Tiara II study is designed to evaluate safety and effectiveness using a transapical approach for implantation of the valve. The 1st site for the study is expected to sign on before the end of the year, with patient enrollment slated for early 2017 and approvals in other jurisdictions on tap.
“We have been very encouraged by the results to date with the Tiara device,” CEO Alexei Marko said in prepared remarks. “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.”
A Massachusetts federal jury in May awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device. Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014. That pushed NVCN shares down some -75% and prompted shareholder Sergio Grobler to file a purported class action lawsuit against Neovasc on behalf of Neovasc stock owners who bought from Neovasc’s January 2015 initial public offering to the date of the May 19 verdict. (The judge overseeing the CardiAQ Valve suit against Neovasc later added $21 million in damages for willfulness).