EDAP's Ablatherm-HIFU Demonstrates Long-Term Efficacy and Safety Over Fourteen-Year Period

EDAP's Ablatherm-HIFU Demonstrates Long-Term Efficacy and Safety Over
Fourteen-Year Period

Longest Retrospective Study of HIFU Patients to Date Published Confirms
Benefits of Treatment

LYON, France, Feb. 8, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today new data
demonstrating the safety and long-term efficacy of Ablatherm-HIFU, an
ultrasound guided HIFU device for the treatment of localized prostate cancer.
The data was electronically published in January 2013 by the British Journal
of Urology, International.

Roman Ganzer, M.D., Primary Investigator and Associate Professor of Urology at
the University of Regensburg in Germany, summarized, "We studied a large
consecutive patient series that underwent primary HIFU for localized prostate
cancer, gathering data over the longest follow-up period in current
literature, with data extending out to 14 years. Our results improve the
understanding of the long term cancer control of HIFU as a primary therapy for
prostate cancer as well as the morbidity associated with the procedure. The
study solidifies the fact that HIFU is a safe and effective therapeutic option
for patients with localized prostate cancer of low and intermediate risk
profile.The morbidity experienced by patients was reasonable and,
specifically, the rate of serious side effects such as recto-urethral fistulae
is very low."

The study, titled "Fourteen-year oncological and functional outcomes of
high-intensity focused ultrasound in localized prostate cancer," was a
fourteen year retrospective single-center study of 538 patients with localized
prostate cancer who underwent primary Ablatherm-HIFU for clinically localized
prostate cancer between November 1997 and September 2009 at the University
Hospital of Regensburg (Germany).The study had a mean follow-up of 8.1 years
and a range of up to 14 years.The findings included favorable oncological
outcomes with biochemical disease-free survival rates at five and 10 years of
88% and 71% for low risk patients and 83% and 63% for intermediate risk
patients, respectively.

John Rewcastle, Ph.D., Medical Director of EDAP TMS, remarked, "This is a
landmark publication as it contains a report of 10 year biochemical outcomes
with follow-up extending to 14 years.The biochemical disease free survival
rates are comparable with those reported following other prostate cancer
treatments and this is balanced with an attractive morbidity profile. This
represents the longest follow-up of any series to date, and validates the
outcomes of Ablatherm-HIFU as first line, whole gland treatment for prostate

About Ablatherm-HIFU

Ablatherm-HIFU is an ultrasound guided HIFU device for the treatment of
organ-confined prostate cancer. The device consists of a treatment module, a
control table with a computer and a computer screen, and a diagnostic
ultrasound device connected to the treatment module. After insertion of an
endorectal probe, the physician visualizes the prostate and defines the area
to be treated. The computer automatically calculates the optimum treatment
distribution of lesions. During the treatment, the transducer automatically
moves and fires at each predefined lesion until the entire area has been
treated, while controlling and imaging the treatment in real time due to its
integrated imaging system. Cell destruction by HIFU is accomplished by a
combination of thermal and cavitation effects caused by focused application of
piezoelectric-generated high-intensity ultrasound. The procedure is performed
under general or spinal anesthesia.

Ablatherm-HIFU is cleared for distribution in the European Union, South Korea,
Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico,
Argentina, Brazil and Russia. As of December 31, 2012, more than 32,000
prostate cancer treatments successfully performed clinical outside the U.S.
with Ablatherm-HIFU and results have been published in 60 peer-reviewed
scientific publications.


EDAP TMS SA develops and markets Ablatherm(R), the most advanced and
clinically proven choice 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. Approved in Europe as a treatment for prostate cancer,
Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing
evaluation in a multi-center U.S. Phase II/III clinical trial under an
Investigational Device Exemption (IDE) granted by the FDA, the ENLIGHT U.S.
clinical study. The Company also is developing this technology for the
potential treatment of certain other types of tumors. EDAP TMS SA also
produces and commercializes medical equipment (the Sonolith(R) 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
         Stephanie Carrington
         The Ruth Group
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