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EDAP Outlines Significant Participation at 2013 American Urological Association Annual Meeting



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.com
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