Healthcare Industry News:  HIFU therapy 

Devices Oncology

 News Release - February 5, 2007

British Journal of Urology Demonstrates Ablatherm Success for Late Stage Prostate Cancer Therapy

Italian Study Shows Up to 90% Efficacy at 12 Months in Stage T2b and T3 High Risk Patients

LYON, France, Feb. 5 (HSMN NewsFeed) -- EDAP TMS S.A. (Nasdaq: EDAP ), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, reports a recent publication outlines successful results achieved in an Italian study of 30 men with high-risk prostate cancer who elected to pursue Ablatherm-HIFU therapy in conjunction with LHRH hormone therapy. The peer reviewed study titled "Short-term outcome after high- intensity focused ultrasound in the treatment of patients with high-risk prostate cancer" was published last December in BJU International.

Ablatherm-HIFU is today used on a routine basis addressing patients with T1-T2 localized prostate cancer who are not candidates for surgery or who wish to avoid side effects directly linked to a prostatectomy procedure. Ablatherm is also offering an alternative to patients who failed a radiotherapy treatment where no other solution was available up to now. Some interest is arising now for using HIFU technology to address patients with high risk prostate cancer (T2b-T3), so far treated with radiotherapy sometimes associated with hormonotherapy or using surgery.

Pr. Vincenzo Ficarra, from University of Padova - Italy, working in the Urology Department directed by Pr. Walter Artibani, co-author of the publication, commented: "In our experimental study, we evaluated the potential application of HIFU and concomitant androgen ablation in a different category of patients, with high-risk prostate cancer. The aim of the study was to verify if HIFU treatment could be considered a minimally invasive alternative to the current recommended treatments for these patients."

Pr. Ficarra continued: "Prostate biopsies performed 12 months after the treatment showed 77% negative biopsies and 90% of the patients treated with HIFU and 3-monthly depot LHRH analogues preparations had undetectable PSA levels, and none had clinical progression of disease. The results of our study also demonstrated that, as in patients with low risk localized prostate cancer, HIFU was a safe treatment for this high risk population, with low complications. A complete urinary continence recovery was obtained in 93% of the cases after 12 months."

Pr. Ficarra concluded: "The results of our study showed that transrectal HIFU treatment combined with LHRH could be a good therapeutic option for patients with high-risk prostate cancer. The low complication rates, with favorable functional outcomes and particularly the promising preliminary oncological data, support the scheduling of further larger studies in such patients. HIFU provides higher safety and precision than divergent energies (cryotherapy, radiotherapy) do. In patients with a high risk for progression or with locally advanced disease, this HIFU treatment might represent a valid alternative to radiotherapy to control local tumor."

EDAP Medical Director Rafael Varona stated, "Ablatherm is already proven successful in the treatment of more than 11,500 patients with early stage localized prostate cancer for patients concerned about quality of life. This study clearly shows that there is potential for patients suffering from more advanced prostate cancers desiring the same opportunities."

Marc Oczachowski, Chief Operating Officer of EDAP TMS, commented: "Dr. Ficarra's study is aiming at enlarging indications for using HIFU in prostate cancer and offering a new therapeutic alternative to high risk cancer patients. This potentiality is interesting as it validates the successful outcomes already achieved by some Ablatherm users in addressing high risk (T2b-T3) patients. EDAP and the Ablatherm HIFU already have the most thorough and prestigious clinical base worldwide, but we continue to expand on our results with increasing success."


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 Halliburton Investor Relations at (972) 458-8000, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at and .

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.

Source: EDAP TMS

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