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EDAP Outlines Significant Participation at 2013 American Urological Association Annual Meeting

  • 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

LYON, France, May 1, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced its participation at the American Urological Association (AUA) 2013 Annual Meeting, held in San Diego on May 4-8, 2013. EDAP will showcase its device portfolio at AUA booth #2845, and the Sonolith i-move will be available for live demonstrations. The Company's HIFU and lithotripsy data will be highlighted in five posters during the AUA scientific session.

EDAP plans to attend the FDA Public Workshop entitled "Clinical Trial Design Issues – Drug and Device Development for Localized Prostate Cancer" that will be held on Sunday, May 5. The workshop will focus on trial design issues related to the development of new therapies for localized prostate cancer including patient selection, comparators, and study endpoints.

Scientific Session Highlights

Date/Time: Monday, May 6, 1:00 pm

Poster 1205: Age stratified outcomes after primary HIFU for organ localized prostate cancer in the series of 5206 patients – This multinational study included 5206 patients from the @-Registry (the online Ablatherm Treatment database) and found similar negative biopsy rates, higher biochemical survivals and lower morbidity for men < 70 years. HIFU had already been recognized as a therapeutic option in patients over 70 years old with 10 years life expectancy and this study demonstrates positive results in a younger population. HIFU therefore appears as a valuable therapeutic option for prostate cancer control independent of age.

Date/Time: Monday, May 6, 1:00 pm

Poster 1206 - Biochemical survival and Morbidity of High Intensity Focused Ultrasound (HIFU) as a Primary Monotherapy for Low-Risk Localized Prostate Cancer: Outcomes from the @-Registry following the ENLIGHT Trial inclusion criteria

The objective of this study was to report the biochemical and biopsy outcomes along with the morbidity of a population of low risk localized prostate cancer patients who meet the the FDA trial inclusion criteria. With a follow-up extending to 18 years, only 8.7% of patients received salvage treatment after HIFU. HIFU achieved good biochemical control at 10 years of follow-up for low risk cancer patients and negative biopsy rates were high. Ablatherm® HIFU treatment appears as a valuable and safe therapy for long term low risk prostate cancer treatment.

Date/Time: Monday, May 6, 3:30 pm

Poster 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 bconfort@edap-tms.com Investors: Stephanie Carrington The Ruth Group 646-536-7017 scarrington@theruthgroup.comSource:EDAP TMS SA