Movers and SHAKERS
The FDA Panel to Decide on Reducer Commercialization in the US
As of April 24, 2020, Noble Capital Markets research on Neovasc is published under ticker symbols (NVCN and NVCN:CA). The price target is in USD and based on ticker symbol NVCN. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target. Neovasc Inc is a specialty medical device company. The company develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina. Neovasc is developing the Tiara for the treatment of mitral valve disease. Neovasc operates its business in one segment.
Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
The FDA panel is scheduled for October 27, 2020. Neovasc submitted a premarket approval application (PMA) for the Reducer device in December 2019 seeking approval for Reducer in the U.S. for the treatment of patients suffering from refractory angina. The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will review the PMA for the Neovasc Reduce device on October 27, 2020.
What do we expect? We believe the decision from the FDA’s panel will be positive. In our view, Reducer represents a solid case based on the benefit demonstrated in patients in the clinical trials (COSIRA and REDUCER-1), the post-market studies demonstrating similar results to the clinical studies, and the strong unmet need in the refractory angina landscape ...
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