The Shareholders Foundation announces that an investor, who purchased shares of EDAP TMS S.A. (ADR) (NASDAQ:EDAP), filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by EDAP TMS S.A. (ADR) in connection with certain allegedly false and misleading statements made between February 1, 2013 and July 30, 2014.
Investors who purchased shares EDAP TMS S.A. (ADR) (NASDAQ:EDAP) have certain options and for certain investors are short and strict deadlines running. Deadline: October 3, 2014. NASDAQ:EDAP investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of purchasers of EDAP TMS S.A. (ADR) (NASDAQ:EDAP) common shares between February 1, 2013 and July 30, 2014, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that between February 1, 2013 and July 30, 2014 Defendants made allegedly false and/or misleading statements and/or failed to disclose that EDAP TMS S.A. was overstating the efficacy and safety of its Ablatherm trials by using faulty statistical methods and presenting misleading data, that EDAP TMS S.A. was understating the frequency of adverse events in its trials for Ablatherm including erectile dysfunction, urinary incontinence, and urethral and bowel injury, and that as a result of the above, the Company’s financial statements were materially false and misleading at all relevant times.
EDAP TMS S.A. reported that its annual Total Revenue declined from $26.07 million in 2012 to $24.07 million in 2013 while its Net Loss declined from $7.48 million in 2012 to $5.04 million in 2013. Shares of EDAP TMS S.A. (ADR) (NASDAQ:EDAP) grew from $2.46 per share in September 2013 to as high as $5.97 per share in early July 2014.
Then 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 July 30, 2014, EDAP TMS S.A. announced an update on the FDA Advisory Committee Meeting on Ablatherm-HIFU for the Treatment of Prostate Cancer.
Shares of EDAP TMS S.A. (ADR) (NASDAQ:EDAP) declined from almost $6 per share in early July 2014 to $1.82 per share on July 31, 2014.
Then on August 5, 2014, EDAP TMS S.A. provided comments on the recent Gastroenterology and Urology Devices Panel (GUDP) vote on the safety, efficacy and risk/benefit ratio for the use of its Ablatherm-HIFU device for treatment of low-risk, localized prostate cancer.
Shares of EDAP TMS S.A. (ADR) (NASDAQ:EDAP) declined to as low as $1.38 per share on August 8, 2014.
On August 19, 2014, NASDAQ:EDAP shares closed at $1.67 per share.
Those who purchased shares of EDAP TMS S.A. (ADR) (NASDAQ:EDAP) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com