LOS ANGELES–(BUSINESS WIRE)–Glancy Prongay & Murray LLP (“GPM”) announces that it has filed a class action lawsuit in the United States District Court for the Southern District of New York captioned Gonzalez v. Neovasc Inc., et al., (Case No. 1:20-cv-09313) on behalf of persons and entities that purchased or otherwise acquired Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN) securities between November 1, 2019 and October 27, 2020, inclusive (the “Class Period”). Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
Investors are hereby notified that they have until 60 days from this notice to move the Court to serve as lead plaintiff in this action.
If you suffered a loss on your Neovasc investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/neovasc-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at firstname.lastname@example.org or visit our website at www.glancylaw.com to learn more about your rights.
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.”
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, on unusually heavy trading volume.
The complaint filed in this class action 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 or otherwise acquired the Neovasc securities during the Class Period, you may move the Court no later than 60 days from this notice to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to email@example.com, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.
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