EDAP's Ablatherm-HIFU Offers Reliable Therapy for Localized Prostate Cancer

EDAP's Ablatherm-HIFU Offers Reliable Therapy for Localized Prostate Cancer

Munich Study Concludes 15 Year Outcome Data May Warrant Closing of
Investigational Phase for HIFU

LYON, France, Feb. 22, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today new long term data
demonstrating high rates of both cancer-specific survival, and freedom from
salvage therapy for patients treated with high-intensity focused ultrasound
(HIFU) therapy. The study was performed by Drs. Stefan Thürroff and Christian
Chaussy and evaluated the cancer control and morbidity of HIFU, in combination
with transurethral resection of the prostate prior to treatment, over a 15
year period. The study was electronically published in February 2013 by the
Journal of Urology, the Official Journal of the American Urological
Association.

The study, titled "Evolution and outcomes of 3 MHz High intensity focused
ultrasound therapy for localized prostate cancer over 15 years," examined 704
patients treated from 1995 to the end of 2009 at the Munich-Harlaching Clinic
located in Munich, Germany. Within the study population, 78.5% of men had
intermediate- or high-risk disease. Data showed a cancer-specific survival
rate after treatment of 99% and a metastasis-free survival rate of 95%. The
salvage treatment-free rates were 98% for low-risk, 72% for intermediate-risk,
and 68% for high-risk disease. The overall survival of the patients in the
study did not differ across risk groups and was identical to current local
(Bavarian) population survival statistics.

Stefan Thüroff, M.D., Primary Investigator and Vice Chairman of the Department
of Urology at the Harlaching Clinic, said, "These study results show that HIFU
offers men with localized prostate cancer a standardized, reliable therapy
with a low rate of perioperative co-morbidity and an absence of serious
morbidity. Importantly, we found that salvage therapy was not required by 98%
of low-risk patients. This outcome is extremely important from the perspective
of the patient, and clearly demonstrates the extent of cancer control afforded
by HIFU therapy."

Dr. Thüroff concluded, "HIFU has remained investigational because the
published research on the therapy has not yet reached sufficient maturity to
be considered definitive. The authors of this study concur that the collected
data of 15 year outcomes may warrant the possible closing of the
investigational phase of whole gland HIFU. The confidence this study provides
in the ability to ablate prostate cancer may also encourage the use of focal
therapy."

John Rewcastle, Ph.D., Medical Director of EDAP-TMS, commented, "This is an
extremely important publication as it not only further establishes the safety,
efficacy, and long term durability of HIFU as a prostate cancer treatment, it
also demonstrates reproducibility. Cancer control outcomes are similar to
those recently published by a separate German research group that reported
outcomes over a 14 year period. Importantly, within this larger and longer
independent study, prostate cancer did not appear to reduce the life
expectancy of those men diagnosed with the disease who underwent HIFU.
Impressively, this was achieved with less than 2% of low-risk patients seeking
salvage treatment and in absence of serious morbidity. This is an impressive
further validation of Ablatherm-HIFU as treatment for prostate cancer."

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 have been successfully performed in clinics outside
the U.S. with Ablatherm-HIFU and results have been published in 60
peer-reviewed scientific publications.

About EDAP TMS SA

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
         bconfort@edap-tms.com
        
         Investors:
         Stephanie Carrington
         The Ruth Group
         646-536-7017
         scarrington@theruthgroup.com
 
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