EDAP Adds World Renowned Cancer Center for Phase II/III Ablatherm-HIFU Clinical Trial

* Reuters is not responsible for the content in this press release.

Thu Apr 10, 2008 9:00am EDT

LYON, France, April 10, 2008 (PRIME NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today that it has received
Institutional Review Board (IRB) approval for Memorial Sloan-Kettering Cancer
Center in New York City to participate in EDAP's ongoing Phase II/III clinical
trial of Ablatherm(r)-High Intensity Focused Ultrasound (HIFU). The trial
compares the outcomes of Ablatherm and Cryotherapy for the treatment of low-risk
prostate cancer. This IRB approval brings the total number of active sites in
the trial to 10 HIFU sites and 6 Cryotherapy sites.

"This clinical trial will evaluate the safety and efficacy of HIFU for the
treatment of prostate cancer," said Dr. James Eastham, Attending Surgeon in the
Urology Service at Memorial Sloan-Kettering. "Results from Europe have been
encouraging, and it is hoped that they will be substantiated by this study and
help further define the role of the procedure both within the United States and
around the world."

John Rewcastle, Ph.D., Medical Director of EDAP TMS, commented, "Memorial
Sloan-Kettering is one of the most respected and active prostate cancer
treatment sites in the world. Their participation in the ENLIGHT study
represents a significant milestone for EDAP as accrual is expected to rapidly
progress due to the large prostate cancer patient population in Manhattan and
the surrounding boroughs."

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are extremely
pleased to add a world premier center like Memorial Sloan-Kettering to
participate in the prospective non-inferiority trial evaluating Ablatherm-HIFU
versus Cryotherapy. As a major U.S. leader in the treatment of prostate cancer,
Memorial Sloan-Kettering further validates the potential of our non-invasive
approach to treating localized prostate cancers and adds credibility to our
technology overall. We believe that the quality of participating sites in this
trial enhances EDAP's profile among urologists, which is supported by the
continued momentum for our patient awareness trial program to accelerate our
screening and recruitment of patients."

About the Study

The prospective non-inferiority study is designed to evaluate the safety and
efficacy of EDAP's Ablatherm-HIFU system versus Cryotherapy for the treatment of
low-risk, localized prostate cancer. The clinical trial is currently enrolling
men over age 60 diagnosed with clinical stage T1a, b, or c or T2a localized
prostate cancer. The primary outcome measure of the trial will be a
statistically significant reduction and stability of the prostate-specific
antigen (PSA) throughout a 24-month follow-up period. Details of the study and
background on Ablatherm-HIFU can be found online at www.ClinicalTrials.gov by
searching for "Ablatherm."

About EDAP TMS SA

EDAP TMS SA develops and markets Ablatherm, 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 multicenter U.S.
Phase II/III clinical trial under an Investigational Device Exemption granted by
the FDA. 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 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, http://www.hifu-planet.com or
http://www.urotoday.com

-0-
CONTACT: EDAP TMS SA
         Investor Relations / Legal Affairs:
         Blandine Confort
         +33 4 72 15 31 72
         bconfort@edap-tms.com

         The Ruth Group
         Investors:
         R.J. Pellegrino
         646-536-7009
         rpellegrino@theruthgroup.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.