- Four scientific sessions highlighting HIFU outcomes for treatment of prostate cancer
- One AUA accepted poster presentation highlighting Sonolith lithotripter and its exclusive ultrasound Visio Track ® localization system
- EDAP attending the FDA Public Workshop on prostate cancer clinical trial design issues
Date/Time: Monday, May 6, 3:30 pmPoster 1355 - Oncological Results of 723 Patients Treated with Radical Prostatectomy or High Intensity Focused Ultrasound Between 2000 and 2005 in the Same Department This comparative study followed a large group of men from a single institution. It showed that 9 years after treatment there was no difference in overall survival rate or the cancer specific survival rate between radical prostatectomy and HIFU. Date/Time: Tuesday, May 7, 8:00 am Poster 1496 - HIFU treatment outcomes for localized prostate cancer from the first European centers The objective of this study, which included 2,162 patients, was to report the outcomes of patients that have been treated in the first European HIFU centers that adopted HIFU. The biochemical survival rate achieved with HIFU at 10 year was encouraging and negative biopsy rates were high across all risk groups. Ablatherm ® HIFU treatment appears as a valuable therapy for long term prostate cancer control. Date/Time: Tuesday, May 7, 8:00 am Poster 1534 - New ultrasound stone locking system in extracorporeal lithotripsy: decreased duration of fluoroscopy and radiation doses The objective of this study was to demonstrate a decrease in the use of fluoroscopy to locate kidney stones for extracorporeal shock wave lithotripsy through the use of a 3D ultrasound stone locking system. EDAP's stone locking system Visio Track ® reduced fluoroscopy in first group of patients, which decreased the amount of radiation used during treatment reducing radiation exposure of treated patients. About EDAP TMS SA EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment., Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com. Forward-Looking Statements In addition to historical information, this press release may contain forward-looking statements that involve risks and uncertainties. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 firstname.lastname@example.org Investors: Stephanie Carrington The Ruth Group 646-536-7017 email@example.com