Healthcare Industry News:  HIFU therapy 

Devices Oncology

 News Release - February 27, 2006

EDAP Reports Significant Growth in Canada

Toronto Clinic Treatments Growing; Successful Treatment of Recurrent Prostate Cancer After Radiotherapy Failures

LYON, France, Feb. 27 (HSMN NewsFeed) -- EDAP TMS S.A. (Nasdaq: EDAP ), the global leader in high intensity focused ultrasound treatment of localized prostate cancer, today announced significant growth in treatment rates and continuing successful outcomes at the Don Mills Surgical Unit in Toronto, Ontario, Canada. North American patients preferring a proven minimally invasive treatment choice have been able to seek AblathermŽ-HIFU treatment for localized prostate cancer at the Toronto clinic since April of 2005. The treatment is fully approved in Canada, Europe and a number of other countries worldwide following extensive testing and treatment experience.

Recent results show high patient satisfaction, minimal impacts on the patient's quality of life compared to other treatment options, and increasing awareness and interest in Ablatherm-HIFU treatment. The clinic's Web site at includes details of the treatment and allows patients to request further information.

"We are seeing an increased level of interest in Ablatherm-HIFU treatment as more people are becoming aware of this preferable option," said Dr. William Orovan, an MD Anderson trained uro-oncologist who is Chairman of the Department of Surgery at McMaster University and who practices urology in the Toronto area. "Many patients throughout North America inquire seeking the best course of treatment. A growing number of them are electing to pursue HIFU once they learn of its proven clinical success established over several trials at multiple sites. These patients often object to traditional surgery or radiation, which require significant recovery time and have high a risk of side effects."

The Toronto clinic is using EDAP's advanced imaging head, which allows the doctor to both image and treat simultaneously, reducing total treatment time and further enhancing accuracy and efficacy.

Dr. Orovan continued, "With the new integrated imaging system, Ablatherm treatment is now averaging less than two hours per patient. Patients are resting comfortably the evening after their treatment, feeling no pain, and with only limited adjustment to their lifestyle for a brief period. Total patient satisfaction with the treatment experience and outcome is extremely high, and we will be presenting results of our experiences to date at several urology conferences in the upcoming months."

Prostate cancer is the leading cancer among North American men with more than 250,000 new cases diagnosed in North America each year. Increasing awareness and testing is leading to a larger percentage of early detection while the disease is still localized making HIFU therapy a viable treatment choice.

Additionally, the Toronto clinic is offering Ablatherm-HIFU treatment to patients suffering from a recurrence of prostate cancer after prior radiation treatment. While studies show a wide range of results, recurrence following radiation treatment can be as high as 45 percent. Such patients have limited options for further treatment as they usually cannot be re-irradiated or have health concerns precluding other invasive methods. Ablatherm-HIFU is shown to be successful in European studies of re-treatment cases for locally recurrent prostate cancer.

"The Ablatherm provides a specialized protocol for treating patients who fail a prior radiation treatment program," said Dr. Orovan. "The prostate has reduced blood flow and different tissue characteristics, which are fully accounted for in the re-treatment protocol, allowing us to safely and effectively treat these patients without additional radiation or surgery while still leaving any other channel of treatment available to the patient if his cancer is particularly aggressive. Many of these patients were at a therapeutic impasse prior to learning about Ablatherm-HIFU, and we are pleased to offer them an effective treatment choice."

Ablatherm-HIFU has more than eight years of patient follow-up data including multi-center studies demonstrating highly reproducible outcomes at various sites. Ablatherm-HIFU technology was developed and perfected in Europe with more than 9,000 clinical treatments to date. European studies have shown that as a curative option Ablatherm-HIFU has had success rates up to 93 percent with up to five years of follow-up. Ablatherm-HIFU can be repeated and does not exclude patients from undergoing other treatment options if their cancer recurs. While the technology does not currently have United States FDA approval, clinical trials are beginning.

Ablatherm-HIFU is a non-invasive, precise and targeted procedure that delivers a beam of high intensity focused ultrasound to the prostate. Under spinal anesthesia, the Ablatherm-HIFU probe is placed into the rectum through which the focused ultrasound waves are directed into the cancerous prostate tissue without damage to the intervening tissue. This causes a rapid rise in temperature inside the prostate cells to 85 degrees Celsius destroying the cancerous cells. The procedure is completed in approximately two hours without blood loss or exposure to radiation.

"The outcomes at the Toronto clinic are an ongoing demonstration of the efficacy and safety of Ablatherm-HIFU in treating localized prostate cancer for patients seeking an effective solution, which will not force them to make significant compromises in their quality of life," said Hugues de Bantel, Chief Executive Officer of EDAP TMS. "The Ablatherm is enjoying rapid acceptance and growth in a number of locations worldwide, especially in European countries where we have established widespread clinical credibility through the demonstration of this technology over many years. Once both patients and their urologists learn of this treatment option it becomes an attractive and, in many cases preferable, choice for both first-indication therapy and re-treatment in cases of recurrence."


EDAP TMS S.A. develops and markets AblathermŽ, 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. The company is also developing this technology for the 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 the Investor Relations Dept. by phone at +33 4 78 26 40 46, or see the Company's Web site at: .

About Don Mills Surgical Unit

Don Mills Surgical Unit is licensed under the Private Hospitals Act by the Government of Ontario and is where AblathermŽ-High Intensity Focused Ultrasound treatment for localized prostate cancer is available. Further information can be found at .

This press release contains, in addition to historical information, 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 the 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 not yet FDA approved or marketed in the United States.

Source: EDAP TMS

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