NEW YORK–(BUSINESS WIRE)–Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Neovasc Inc. (NASDAQ: NVCN) resulting from allegations that Neovasc may have issued materially misleading business information to the investing public.
On December 20, 2018, Neovasc 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, the Company 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, the Company 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 November 28, 2020, prior to markets opening, Neovasc 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.
On this news, stock prices dropped from closing at $1.83 on October 27, 2020 to open at $1.10 on October 28, 2020. The shares closed at $1.06 that day.
Rosen Law Firm is preparing a securities lawsuit on behalf of Neovasc shareholders. If you purchased securities of Neovasc please visit the firm’s website at http://www.rosenlegal.com/cases-register-1976.html to join the securities action. You may also contact Phillip Kim of Rosen Law Firm toll free at 866-767-3653 or via email at email@example.com or firstname.lastname@example.org.
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Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.
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