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Case Status:    DISMISSED    
On or around 10/08/2015 (Date of order of final judgment)

Filing Date: August 04, 2014

According to the law firm press release, 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.

On September 14, 2015, the Court issued an Order granting Defendants' motion to dismiss.

COMPANY INFORMATION:

Sector: Healthcare
Industry: Medical Equipment & Supplies
Headquarters: France

SECURITIES INFORMATION:

Ticker Symbol: EDAP
Company Market: NASDAQ
Market Status: Public (Listed)

About the Company & Securities Data


"Company" information provides the industry and sector classification and headquarters state for the primary company-defendant in the litigation. In general, "Securities" information provides the ticker symbol, market, and market status for the underlying securities at issue in the litigation.

In most cases, the primary company-defendant actually issued the securities that are the subject of the litigation, and the securities information and company information relate to the same entity. In a small subset of cases, however, the primary company-defendant is not the issuer (for example, cases against third party brokers/dealers), and the securities information and company information do not relate to the same entity.
COURT: S.D. New York
DOCKET #: 14-CV-06069
JUDGE: Hon. Lorna G. Schofield
DATE FILED: 08/04/2014
CLASS PERIOD START: 02/01/2013
CLASS PERIOD END: 07/30/2014
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Bronstein, Gewirtz & Grossman, LLC (New York)
    60 East 42nd Street - Suite 4600, Bronstein, Gewirtz & Grossman, LLC (New York), NY 10165
    212.697.6484 212.697.7296 · info@bgandg.com
  2. Pomerantz LLP (New York)
    600 Third Avenue, Pomerantz LLP (New York), NY 10016
    212.661.1100 212.661.8665 · info@pomerantzlaw.com/
No Document Title Filing Date
COURT: S.D. New York
DOCKET #: 14-CV-06069
JUDGE: Hon. Lorna G. Schofield
DATE FILED: 12/22/2014
CLASS PERIOD START: 02/01/2013
CLASS PERIOD END: 07/30/2014
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Bronstein, Gewirtz & Grossman, LLC (New York)
    60 East 42nd Street - Suite 4600, Bronstein, Gewirtz & Grossman, LLC (New York), NY 10165
    212.697.6484 212.697.7296 · info@bgandg.com
  2. Pomerantz LLP (New York)
    600 Third Avenue, Pomerantz LLP (New York), NY 10016
    212.661.1100 212.661.8665 · info@pomerantzlaw.com/
No Document Title Filing Date