Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against EDAP TMS S.A.

EDAP is a holding company and is responsible for providing common services to its subsidiaries, including preparation and consolidation of the financial statements for the group, complying with the requirements of various regulatory agencies and maintaining the listing of its publicly held securities and, in conjunction with its Board of Directors, directing the overall strategy of its group.  The Complaint alleges that throughout the Class Period, defendants made materially false and misleading statements, and omitted materially adverse facts, about the Company's business, operations and prospects.  Specifically, the Complaint alleges that the defendants concealed from the investing public that: (1) the Company was overstating the efficacy and safety of its Ablatherm trials by using faulty statistical methods and presenting misleading data; (2) 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 (3) as a result of the above, the Company's financial statements were materially false and misleading at all relevant times.  As a result of defendants' alleged false and misleading statements, the Company's stock traded at artificially inflated prices during the Class Period. 

According to the Complaint, 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 ("GUDP") meeting (the "FDA Staff Report").  In the FDA Staff Report, the FDA questioned whether EDAP's methods for testing the device were adequate.  The FDA Staff Report also noted the high rates of adverse events associated with Ablatherm, including erectile dysfunction and urinary incontinence, clinically significant rates of stricture, urethral injury and bowel injury, which the Company had not properly presented in a clinically meaningful way.

Then, on July 30, 2014, the Company issued a press release and filed a Form 6-K with the SEC, providing an update on the FDA Advisory Committee Meeting on Ablatherm.  According to the press release, the GUDP voted 3 yes, 5 no with 1 abstention on the question of safety, 9 no on the question of efficacy, and 8 no with 1 abstention for the risk/benefit ratio for the use of its Ablatherm-HIFU device for the treatment of low-risk, localized prostate cancer. 

On this news, shares in EDAP plummeted more than 43%, closing at $1.92 per share on July 31, 2014, on unusually heavy trading volume.         

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.  In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class.  Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff.  Any member of the proposed class may move the court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.

While Rigrodsky & Long, P.A. did not file the Complaint in this matter, the firm, with offices in Wilmington, Delaware and Garden City, New York, regularly litigates securities class, derivative and direct actions, shareholder rights litigation and corporate governance litigation, including claims for breach of fiduciary duty and proxy violations in the Delaware Court of Chancery and in state and federal courts throughout the United States.

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CONTACT: 

Rigrodsky & Long, P.A.
Timothy J. MacFall, Esquire
Peter Allocco
(888) 969-4242
(516) 683-3516
Fax: (302) 654-7530
info@rl-legal.com 
http://www.rigrodskylong.com

SOURCE Rigrodsky & Long, P.A.