NEW YORK–(BUSINESS WIRE)–Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Neovasc, Inc. (NASDAQ: NVCN) on behalf of Neovasc stockholders. Our investigation concerns whether Neovasc has violated the federal securities laws and/or engaged in other unlawful business practices.
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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, the company’s stock price dropped from closing at $1.83 per share on October 27, 2020, to close at $1.06 per share on October 28, 2020.
If you purchased or otherwise acquired Neovasc shares and suffered a loss, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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