EDAP Ablatherm-HIFU Presents at American Urology Association Accelerates US Study Enrollment

Planet edap Inc.
May 23,2007

EDAP Ablatherm-HIFU Presents at American Urology Association Accelerates US Study Enrollment

EDAP Ablatherm-HIFU Presents at American Urology Association Accelerates US Study EnrollmentLYON, France, May 23 /PRNewswire-FirstCall/ -- EDAP TMS S.A. (Nasdaq: EDAP), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, reports the continuing advancement of its clinical trial and education programs at the American Urology Association Congress in Anaheim May 19-22, 2007. EDAP's booth was well attended with inquiries about its Ablatherm-HIFU line for localized prostate cancer, currently in US clinical trials, and its well established lithotripsy business which unveiled the next generation lithotripter intended for European and USA sales.

"We received very strong interest from the urology community in both our newly unveiled Sonolith I-sys and the Ablatherm-HIFU's continuing strong clinical results," said Marc Oczachowski, CEO of EDAP. "The S.I-sys received high marks for its features and ease of use. With more than 25 years in the urology market, EDAP is a well known name. The S.I-sys will begin European delivery in September of this year. This device is designed to address the high demand needs of lithotripsy centers and support broader awareness of EDAP."

As announced previously, EDAP will accelerate its ongoing US clinical trial of the Ablatherm-HIFU device with strong awareness and outreach under its direction with full ownership of the study. Based on strong results recently released in Europe showing sustainable outcomes at 8 years and growing US interest in the clinical program by urologists, EDAP is currently fielding several inquiries from centers wishing to join the study and deploying greater resources to the clinical program. EDAP hosted its first investigator meeting since assuming full control of the study with strong support and commitment from the centers.

EDAP's participation in the AUA event included poster presentations on:

  • EDAP's ongoing long term clinical success including a video presentation of outcomes from the first 10 years of Ablatherm-HIFU therapy in Germany, attended by more than 300 urologists,


  • a cost comparison concluding Ablatherm-HIFU can be lower in cost than six common therapies such as robotic surgery, external radiation or brachytherapy, and


  • preliminary outcomes in a study of Ablatherm combined with hormone and radiation therapies for metastatic cancers and use of Ablatherm-HIFU as a documented salvage therapy option of proven success.

"EDAP continues the advancement of HIFU therapy in localized prostate cancer," said Oczachowski. "With the strong enthusiasm of our US clinical centers to conduct the Ablatherm US study more rapidly, we have every expectation of success in bringing Ablatherm-HIFU to American patients seeking high quality of life as well as effective treatment. Many of the best centers in the US have contacted EDAP with interest in joining the study as additional sites, and we are presently discussing options with them as well as securing the necessary approvals. In the interim, we continue to educate urologists on our study as well as the ideal indications making Ablatherm an established consideration for patients with localized prostate cancer."

The Ablatherm-HIFU Phases II/III clinical study is currently enrolling men diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer. HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue. Details of the study and background on Ablatherm-HIFU can be found online at www.clinicaltrials.gov by searching for "Ablatherm." The therapy generally requires one session of two to three hours and a minimum of recuperative time. Ablatherm-HIFU is proven effective comparable to other standard nonsurgical treatments of localized prostate cancer, but often with lower side effects. The highly robotized procedure offers clear statistically predictive outcomes without any impasse to future care if it should be required. Ablatherm is also the HIFU system with proven dedicated protocols for treatment of recurrent prostate cancer following failed radiation therapy.

About EDAP TMS S.A.

EDAP TMS S.A. 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. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).

For more information on the Company, contact Magnolia Investor Relations at (972) 801-4900, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at http://www.edap-tms.com and http://www.hifu-planet.com.

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In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties 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. Ablatherm- HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United States.

CONTACT:   EDAP TMS S.A.               Magnolia Investor Relations
           Blandine Confort            Matt Kreps
           +33 4 78 26 40 46           972 801 4900

SOURCE EDAP TMS S.A.