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EDAP TMS S.A. EDAP Securities Lawsuit

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Company: EDAP TMS S.A.
Ticker Symbol: EDAP
Class Period: Feb-1-13 to Jul-30-14
Date Filed: Aug-15-14
Lead Plaintiff Deadline: Oct-14-14
Court: Southern District of New York
Allegations:
Los Angeles, CA: A securities class action lawsuit has been filed against EDAP TMS S.A. ("EDAP" or the "Company") and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 14-cv-6069, is on behalf of a class consisting of all persons or entities who purchased EDAP securities 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").

Defendant EDAP TMS S.A., through its subsidiaries, designs and manufactures medical equipment. The Company develops minimally invasive therapeutic ultrasound solutions for urology, tumor removal, localized prostate cancer, and related infectious diseases. EDAP purports to serve patients and medical professionals worldwide.

The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, and failed to disclose material adverse facts about the Company's business, operations, prospects and performance. Specifically, 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. EDAP relied on a registry of patients in Europe who have used Ablatherm, and compared their data to a subgroup of patients in a U.S. Department of Veterans Affairs trial who underwent surgery called radical prostatectomy. Patients who used Ablatherm had a 1.1 percent risk of their cancer spreading after eight years, compared to a 1.4 percent risk for men who underwent surgery.

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 acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.

EDAP TMS S.A. EDAP Securities Fraud Legal Help

If you have suffered from financial losses, you may qualify for damages or remedies that may be awarded in a possible EDAP TMS S.A. securities class action lawsuit. Please click the link below to submit your complaint for a free evaluation.

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