Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, 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 intends to submit a full Premarket Approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for its Neovasc Reducer™ (“Reducer”) medical device for the treatment of refractory angina before the end of 2019.

Neovasc has been meeting with the FDA to discuss potential options to bring Reducer to the U.S. market. Following the last Sprint discussion held with the FDA on October 9, 2019 and weighing all available options a final decision was made by the Company to pursue a full PMA application for this Breakthrough medical device.

“We believe that the totality of clinical evidence from the COSIRA study, REDUCER-I European Post-Market study (with over 200 of 400 patients enrolled), and multiple independent studies published in peer-reviewed journals, will provide reasonable assurance of safety and effectiveness to support a PMA. Neovasc plans to submit the PMA application prior to the end of 2019 with a request for an Advisory Panel meeting,” said Fred Colen, President and CEO of Neovasc.

“While any pathway to U.S. market approval by the FDA carries considerable risk, we believe the full PMA application pathway brings the best chance of success within reasonable cost and time constraints.  After evaluating the different options, we concluded that the Humanitarian Use Device (“HUD”) pathway would likely not be a viable option based on the definition of an HUD device within the FDA Guidance and that the PMA pathway would be our best option to bring Reducer to the U.S. market to treat refractory angina patients.  While an additional post-market study will most likely be needed and the body of real-world evidence continues to grow, the Company believes that the clinical evidence already available will be sufficient to not further delay the availability of this Breakthrough medical device for the treatment of U.S. patients.”

Source: Company Press Release