NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of investors that purchased Neovasc, Inc. (NASDAQ: NVCN) securities between October 10, 2018 and October 27, 2020 (the “Class Period”). Investors have until January 5, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Click here to participate in the action.
Neovasc is a specialty medical device company that develops, manufactures and markets products for cardiovascular diseases, including the Tiara technology and the Reducer. The Company’s Reducer is a medical device that treats refractory angina by altering blood flow in the heart’s circulatory system.
On October 28, 2020, before the market opened, the Company announced that an FDA advisory panel voted overwhelmingly against the safety and effectiveness of the Reducer. The panel noted concerns with the Company’s clinical data, including “that the lack of blinding assessment made the primary endpoint difficult to interpret.” As a result, the panel reached a consensus “that additional premarket randomized clinical data was necessary.”
On this news, the Company’s share price fell $0.77, or 42%, to close at $1.06 per share on October 28, 2020.
The complaint, filed on November 5, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the results of COSIRA, Neovasc’s clinical study for the Reducer, contained imbalances in missing information present in the control group versus the treatment group, including significant missing information for secondary endpoints but none for the primary endpoint; (2) that the imbalance in missing information indicated that control subjects were aware of their treatment assignment (not blinded) and less inclined to participate in additional data collection; (3) that blinding is critical when studying a placebo-responsive condition such as angina; (4) that the lack of blinding assessment made the primary endpoint difficult to interpret; (5) that, as a result of the foregoing, the FDA was reasonably likely to require additional premarket clinical data; (6) that, as a result, the Company’s PMA for Reducer was unlikely to be approved without additional clinical data; and (7) that, as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
If you purchased Neovasc securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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