Neovasc (NVCN) announced that Tiara Transapical system will be unable to receive European CE mark under current Medical Device Directive regulations

April 16, 2021 9:06 AM EDT

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via NewMediaWire -- Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), today announced that the Tiara Transapical system (“Tiara TA”) will be unable to receive a European CE mark under the current Medical Device Directive regulations (“MDD”) ending on May 26, 2021. The Company is collaborating with its European Notified Body (the “Notified Body”) on potential next steps.

Neovasc has been working with its Notified Body for more than a year to obtain a decision on a CE Mark for Tiara TA, including an ongoing exchange of additional information beyond the original submission. The Company has determined that it will be unable to provide the additional information required by the Notified Body, which includes further testing data, before the current MDD regulations end next month.

The MDD is set to be replaced by the newer Medical Device Regulation (“MDR”) on May 26, 2021. A CE Mark under either the MDD or MDR regulations would allow the Company to commercialize the Tiara TA system in Europe.

“We are disappointed that the MDD regulations are going to be replaced before we are able to gain CE Mark approval for the Tiara TA system,” said Fred Colen, Chief Executive Officer Neovasc. “We believe that the Tiara valve has shown to be a remarkable device and we are pleased with the safety and efficacy profile the device has displayed in clinical trials to date. Our team has worked tirelessly, and we believe we have made meaningful progress with our notified body during COVID-19 lockdowns to advance the approval process, but we have run out of time to complete the review before the transition to MDR next month, our previously announced target date for a CE mark decision.”

The Company expects to provide an update at, or around, the upcoming Q1 2021 Earnings Call scheduled for early May.

The transition from MDD to MDR does not impact the Tiara transfemoral program (“Tiara TF”). The Company has always anticipated that Tiara TF’s CE Mark submission would be assessed under MDR.



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