BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces an investigation on behalf of Neovasc, Inc (“Neovasc” or the “Company”) (NASDAQ: NVCN) investors concerning the Company’s possible violations of federal securities laws.
Neovasc’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, the Company announced that, despite “Breakthrough Device Designation”, the FDA review team recommended collection of further pre-market blinded data prior to Pre-Market Approval (“PMA”) submission.
On November 1, 2019, Neovasc announced that it would submit a PMA application for the Reducer without gathering further evidence, against the FDA’s recommendation. The Company 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, Neovasc announced that an FDA advisory committee voted overwhelmingly against issuing a reasonable assurance of effectiveness and on whether the relative benefits outweighed the relative risks. The panel echoed concerns previously raised by the FDA about the lack of sufficient data.
On this news, the Company’s share price fell $0.77, or 42%, to close at $1.06 per share on October 28, 2020, thereby injuring investors.
If you purchased Neovasc securities, have information or 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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
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