NEW YORK, Aug. 5, 2014 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York, on behalf of all persons who purchased or otherwise acquired the securities of EDAP TMS S.A. ("EDAP" or the "Company") (Nasdaq:EDAP) during the period between February 1, 2013 and July 30, 2014, inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934 (the "Exchange Act").
The Complaint alleges that during the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company was overstating the efficacy and safety of its Ablatherm trials by using faulty statistical methods and presenting misleading data; (ii) the Company was understating the frequency of adverse events in its trials for Ablatherm including erectile dysfunction, urinary incontinence, and urethral and bowel injury; and (iii) as a result of the above, the Company's financial statements were materially false and misleading at all relevant times.
On July 28, 2014, a U.S. Food and Drug Administration ("FDA") staff report was released in anticipation of a July 30, 2014 meeting of the Gastroenterology and Urology Devices Panel Advisory Committee meeting (the "FDA Staff Report"). In the FDA Staff Report, the FDA questioned whether EDAP's methods for testing the device were adequate. Specifically, FDA staff questioned EDAP's safety and effectiveness data because the Company compared patients in two different studies to gather evidence, rather than a head-to-head trial.
On the news, EDAP stock fell $1.23 in unusually heavy volume, or over 25%, to close at $3.65 on July 28, 2014.
If you wish to serve as lead plaintiff, you must move the Court no later than October 3, 2014. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, or to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at firstname.lastname@example.org or email@example.com.
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Source:Gainey McKenna& Egleston