According to the Complaint, Neovasc Inc. 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.

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, the Complaint alleges 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.

On January 26, 2021, the Court issued an Order consolidating cases and appointing Lead Plaintiff and Counsel. Lead Plaintiff filed a consolidated amended Complaint on March 19. Defendants filed a Motion to Dismiss the consolidated amended Complaint on August 9.

On February 1, 2022, the Court issued an Order granting Defendants' Motion to Dismiss. The case was dismissed with prejudice without leave to amend, and the Clerk of the Court was directed to close the case.

On February 22, 2022, Plaintiff filed a notice appealing the Court's Dismissal Order. The Court of Appeals affirmed the District Court's ruling on April 3, 2023.