Neovasc Inc. Class Action Lawsuit

34 days left to seek lead plaintiff status

Case Summary

Company Name
Neovasc Inc.
Stock Symbol
Class Period
November 1, 2019 to October 27, 2020
Motion Deadline
January 5, 2021
Southern District of New York

The Neovasc Inc. class action lawsuit charges Neovasc and certain of its executives with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers or acquirers of Neovasc securities between November 1, 2019 and October 27, 2020, inclusive (the “Class Period”).  The Neovasc class action lawsuit was commenced on November 5, 2020 in the Southern District of New York and is captioned Gonzalez v. Neovasc Inc., No. 20-cv-9313.

Neovasc is a specialty medical device company that develops, manufactures and markets products for cardiovascular diseases, including the Tiara technology and the Reducer.  Neovasc’s Reducer is a medical device that treats refractory angina by altering blood flow in the heart’s circulatory system.  In December 2018, Neovasc 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 had recommended that Neovasc collect further pre-market blinded data prior to submitting a Pre-Market Approval (“PMA”) application.  However, on November 1, 2019, Neovasc 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 Neovasc class action lawsuit alleges that, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) the results of COSIRA, Neovasc’s clinical study for the Reducer, contained an imbalance 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) the imbalance in missing information indicated that control subjects were aware of their treatment assignment (i.e., the study was not blinded, which is critical when studying a placebo-responsive condition such as angina) and less inclined to participate in additional data collection; (3) the lack of blinding assessment made the primary endpoint difficult to interpret; (4) as a result, the FDA was reasonably likely to require additional pre-market clinical data and Neovasc’s PMA for Reducer was unlikely to be approved without this additional clinical data; and (5) as a result of the foregoing, defendants’ positive statements about Neovasc’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

On October 28, 2020, before the market opened, Neovasc announced that an FDA advisory panel had voted overwhelmingly against the safety and effectiveness of the Reducer.  The panel noted concerns with Neovasc’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, Neovasc’s share price fell more than 42%, damaging investors.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Neovasc securities during the Class Period to seek appointment as lead plaintiff in the Neovasc class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the Neovasc class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the Neovasc class action lawsuit.  An investor’s ability to share in any potential future recovery of the Neovasc class action lawsuit is not dependent upon serving as lead plaintiff.  If you wish to serve as lead plaintiff of the Neovasc class action lawsuit or have questions concerning your rights regarding the Neovasc class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at jsanchez@rgrdlaw.com.  Lead plaintiff motions for the Neovasc class action lawsuit must be filed with the court no later than January 5, 2021.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation.  With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history.  For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements.  Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims.  Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide.  Robbins Geller attorneys are consistently recognized by courts, professional organizations and the media as leading lawyers in the industry.

Class Period: November 1, 2019 - October 27, 2020
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