NEW YORK, Aug. 29, 2014 /PRNewswire/ -- Pomerantz LLP has
filed a class action lawsuit against EDAP TMS S.A. ("EDAP" or
the "Company") (NASDAQ: EDAP) 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").
If you are a shareholder who purchased EDAP securities during
the Class Period, you have until October 3,
2014 to ask the Court to appoint you as Lead Plaintiff for
the class. A copy of the Complaint can be obtained at
www.pomerantzlaw.com. To discuss this action, contact
Robert S. Willoughby at
rswilloughby@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll
free, x237. Those who inquire by e-mail are encouraged to include
their mailing address, telephone number, and number of shares
purchased.
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.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and San
Diego, is acknowledged as one of the premier firms in the
areas of corporate, securities, and antitrust class litigation.
Founded by the late Abraham L.
Pomerantz, known as the dean of the class action bar, the
Pomerantz Firm pioneered the field of securities class actions.
Today, more than 70 years later, the Pomerantz Firm continues in
the tradition he established, fighting for the rights of the
victims of securities fraud, breaches of fiduciary duty, and
corporate misconduct. The Firm has recovered numerous
multimillion-dollar damages awards on behalf of class members. See
www.pomerantzlaw.com.
CONTACT:
Robert S.
Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
SOURCE Pomerantz LLP