November 6, 2020 - An investor in shares of Neovasc Inc. (NASDAQ: NVCN) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Neovasc Inc. in connection with certain allegedly false and misleading statements made between November 1, 2019 and October 27, 2020.

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.

According to the complaint the plaintiff alleges on behalf of purchasers of Neovasc Inc. (NASDAQ: NVCN) common shares between November 1, 2019 and October 27, 2020, that the defendants violated Federal Securities Laws. More specifically, 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.