Lawsuit filed for Investors in shares of Neovasc Inc. (NASDAQ: NVCN)

An investor, who purchased shares of Neovasc Inc. (NASDAQ: NVCN), filed a lawsuit over alleged violations of Federal Securities Laws by Neovasc Inc.

Investors who purchased shares of Neovasc Inc. (NASDAQ: NVCN) have certain options and for certain investors are short and strict deadlines running. Deadline: January 5, 2021. NASDAQ: NVCN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Canada based Neovasc Inc., a specialty medical device company, develops, manufactures, and markets medical devices for cardiovascular marketplace in Europe, the United States, and internationally.

On December 20, 2018, Neovasc Inc. filed a comprehensive Q-Sub submission to the FDA with all available evidence for its product Neovasc Reducer, including the prospective, multicenter, randomized, double-blind, sham controlled study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada (COSIRA), a multi-center, multi-country, three-arm observational post market study (REDUCER-I), and supportive safety and efficacy data from peer-reviewed journals.
On February 20, 2019, Neovasc Inc. announced that the FDA had informed Neovasc that, despite “Breakthrough Device Designation”, the FDA review team recommended collection of further pre-market blinded data prior to Pre-Market Approval submission.
On October 9, 2019, despite recommendations from the FDA to the contrary, Neovasc Inc. decided to pursue a PMA application for this Breakthrough medical device without gathering any further evidence. Thereafter, the Company made optimistic statements regarding the likelihood of approval, such as, “the Company believes 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, prior to markets opening, Neovasc Inc. announced that, although the FDA voted that the Reducer is safe when used as intended, they voted overwhelmingly against issuing a reasonable assurance of effectiveness and on whether the relative benefits outweighed the relative risks.

Shares of Neovasc Inc. (NASDAQ: NVCN) declined to as low as $0.87 per share on October 30, 2020.

The plaintiff claims that between November 1, 2019 and October 27, 2020, the Defendants failed to disclose to investors 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, 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, that blinding is critical when studying a placebo-responsive condition such as angina, that the lack of blinding assessment made the primary endpoint difficult to interpret, that, as a result of the foregoing, the FDA was reasonably likely to require additional premarket clinical data, that, as a result, the Company’s PMA for Reducer was unlikely to be approved without additional clinical data, and 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.

Those who purchased shares of Neovasc Inc. (NASDAQ: NVCN) have certain options and should contact the Shareholders Foundation.

Media Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.