Ten years of high intensity focused ultrasound treatment for prostate cancer

23 April 2006

Lyon, France. EDAP TMS S.A. (NASDAQ:EDAP), supplier of high intensity focused ultrasound treatment of localized prostate cancer, presented the 10-year Ablatherm - HIFU European experiences and a review of results of treatments dating back to 1995 on patients who had failed prior radiation therapy, at a special dedicated symposium during the European Association of Urology conference in Paris, 5-8 April.

Dr. Francois-Joseph Murat of Edouard Herriot University Hospital, Lyon, presented details of Ablatherm-HIFU results when used as salvage therapy following external beam radiation therapy failure on more than 150 patients between 1995 and 2006.

Patients fail radiotherapy treatment of localized prostate cancer at rates up to 50% and have few current treatment choices, all with significant side effects. Almost all patients are offered palliative care options — designed to reduce symptoms and slowing disease progression but not stopping the cancer — rather than curative solutions such as surgery or cryotherapy, which are difficult to use in these cases and present substantial complications making them often undesirable.

Dr. Murat's study demonstrated Ablatherm-HIFU provided a 76.5% negative biopsy rate and PSA back to normal in local tumour control with low levels of side effects, especially as compared to alternate therapy side effect rates. Control of the cancer was highly correlated to the pre-radiation cancer risk level with those patients at earlier stages showing the best outcomes.

The results also demonstrated that specific post-radiation failure protocols introduced for Ablatherm-HIFU in 2002 reduced the occurrence of fistulas to zero and lowered the occurrence of incontinence to below surgery and cryotherapy incidence rates. This confirms Ablatherm-HIFU as a preferable choice for both limiting side effects and treating the cancer itself as compared to other options with lower success rates and higher side effect occurrences.

Dr. Stefan Thuroff presented a discussion on efficacy, results and safety covering 10 years of experience based on treatments at University Hospital of Munich, Harlaching, Germany. The 10-year experience with Ablatherm-HIFU in Europe clearly demonstrates the clinical, technical and safety strength compared to other treatments. In 2006 Ablatherm-HIFU is now fully accepted as a treatment for localized prostate cancer, offering a minimally invasive solution for patients with localized prostate cancer who cannot undergo surgery or fail radiotherapy.

Over the past 10 years, EDAP has been fully dedicated to enhancing the Ablatherm-HIFU bringing average treatment times now to 95 minutes following the introduction of the advanced imaging head. Also, the company introduced nerve-sparing applications that can preserve potency in up to 85% of patients electing this option. A review of the first indication patient data including patients treated in 1996 shows incontinence in less than 2% of patients and preservation of potency in 45% of patients electing complete prostate treatment rather than nerve sparing choices, comparing very well or better against traditional care options. Dr. Thuroff's presentation reiterated negative biopsy rates from 79.4% in locally advanced prostate cancer to 93.7% in localized low to medium risk prostate cancer cases.

Dr. Gail ter Haar of the Institute for Cancer Research at the Royal Marsden NHSF Trust, Surrey, U.K., and a principal investigator of HIFU technology on a global scale, presented an outstanding review of HIFU principles and applications to date as well as a summation of HIFU technology marketed today among which the Ablatherm is a leading choice. Specifically, the Ablatherm-HIFU addresses the localized prostate cancer market with its best-in-class integrated imaging, industry-leading safety features and efficient treatment. Dr. ter Haar's presentation concluded that HIFU is becoming a choice in future therapies based on significant benefits including its minimally invasive profile, repeatability, flexibility and efficacy.

"These results confirm Ablatherm-HIFU is the most clinically advanced HIFU choice in treating localized prostate cancer with excellent success, lower side effects and better preservation of the patient's quality of life. The studies also show Ablatherm-HIFU is fully capable of providing a curative treatment choice for even patients in some of the most clinically difficult situations of recurrence post radiation, where medical professionals are often at an impasse of curative therapy," said Hugues de Bantel, CEO of EDAP. "Our dedicated symposium event was very well attended by urologists from around the world who are attracted to EDAP based on our ability to provide clinical results, complete training support and unparalleled clinical outcomes. EDAP is the only HIFU provider to have 10-year experience in localized prostate cancer treatment. Our outcomes compare well against all established therapies. Urologists and oncologists are increasingly inquiring about the option of offering Ablatherm-HIFU in their clinic after seeing these demonstrated results, something no other company can offer or represent. Our new marketing and education programs continue to grow ever more interest and demand for Ablatherm-HIFU."

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