NEW YORK, NY / ACCESSWIRE / December 23, 2020 / Pomerantz LLP announces that a class action lawsuit has been filed against Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ:NVCN) and certain of its officers. The class action, filed in United States District Court for the Southern District of New York, and docketed under 20-cv-09948, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise acquired Neovasc securities between October 10, 2018 and October 27, 2020, inclusive (the "Class Period"). Plaintiff pursues claims against the Defendants under the Securities Exchange Act of 1934 (the "Exchange Act").
If you are a shareholder who purchased Neovasc securities during the Class Period, you have until January 5, 2021, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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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.
In December 2018, the Company filed a Q-Sub submission to the U.S. Food and Drug Administration ("FDA") that contained safety and efficacy results from Neovasc's clinical studies, as well as supporting data from peer-reviewed journals.
On February 20, 2019, Neovasc announced that, despite "Breakthrough Device Designation," the FDA review team recommended that the Company collect further pre-market blinded data prior to submitting a Pre-Market Approval ("PMA") application.
On November 1, 2019, the Company announced that it would submit a PMA application for the Reducer without gathering further evidence, against the FDA's recommendation. Neovasc claimed 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."
The complaint 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 that: (i) Neovasc had overstated the viability of U.S. approval of the Reducer based on its "Breakthrough Device Designation" and prior studies supporting the Reducer's efficacy and safety; (ii) the results of Neovasc's clinical studies used to support approval for the Reducer in the U.S. 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; (iii) 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; (iv) blinding is critical when studying a placebo-responsive condition such as angina; (v) the lack of blinding assessment made the primary endpoint difficult to interpret; (vi) as a result of the foregoing, the FDA was reasonably likely to require additional premarket clinical data; (vii) as a result, the Company's PMA for Reducer was unlikely to be approved without additional clinical data; and (viii) 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.
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 common share price fell $0.77 per share, or 42%, to close at $1.06 per share on October 28, 2020, on unusually heavy trading volume.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
SOURCE: Pomerantz LLP