By a News Reporter-Staff News Editor at Drug Week -- Shareholder rights law firm Robbins Arroyo LLP announces that an investor of EDAP TMS S.A. (NASDAQ: EDAP) has filed a federal securities fraud class action complaint in the U.S. District Court for the Southern District of New York. The complaint alleges that the company and certain of its officers and directors violated the Securities Exchange Act of 1934 between February 1, 2013 and July 30, 2014 (the "Class Period"). EDAP develops, produces, and markets minimally invasive medical devices for the treatment of urological diseases (see also Robbins Arroyo Llp).
EDAP Is Accused of Overstating the Safety of Ablatherm
According to the complaint, on July 28, 2014, shares of EDAP dropped over 25% to close at $3.65 following the release of a U.S. Food and Drug Administration staff report questioning whether EDAP's testing methods were adequate. Specifically, the FDA staff report listed concern with EDAP's safety and effectiveness data because it was collected by comparing patients in two separate studies instead of a head-to-head trial. To acquire their data, EDAP used a registry of patients in Europe with organ-confined prostate cancer who had used Ablatherm, a High Intensity Focused Ultrasound device, as a treatment method and a subgroup of patients in a U.S. Department of Veterans Affairs trial who underwent a surgical treatment. EDAP's data showed that after eight years, patients who used Ablatherm has a 1.1 % risk of their cancer spreading compared to 1.4% risk for those patients who underwent surgery.
The complaint further alleges that EDAP made false and/or misleading statements and failed to disclose: (i) the company was overstating the efficacy and safety of its Ablatherm trials and using faulty statistical methods and presenting misleading data; (ii) the company was understating the frequency of adverse events in its trials for Ablatherm; and (iii) as a result, the company's financial statements were materially false and misleading.
EDAP Investors Are Encouraged to Contact Shareholder Rights Law Firm Robbins Arroyo LLP
If you invested in EDAP and would like to discuss your shareholder rights, please contact attorney Darnell R. Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the information form on the firm's shareholder rights blog: www.robbinsarroyo.com/shareholders-rights-blog/edap-tms-s-a
Robbins Arroyo LLP is a nationally recognized leader in securities litigation and shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested.
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