EDAP Reports Publication of Long-Term Clinical Results for Largest Cohort of Ablatherm-HIFU Patients

/ Source: GlobeNewswire

LYON, France, Sept. 8, 2010 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today reported favorable clinical outcomes for patients treated with Ablatherm-HIFU. A total of 803 patients with localized prostate cancer, treated with Ablatherm-HIFU from 1993 until 2007, were reported in a study carried out by Dr. Sébastien Crouzet, Urologist at Edouard Herriot Hospital, Lyon, France. The analysis has been published electronically by the medical journal European Urology, the official scientific publication of the European Association of Urology, and will appear in an upcoming print edition of European Urology. These results were recently presented by Dr. Crouzet at the World Congress of Endourology in Chicago.

This French multi-centric study reports the largest series of patients who have been followed for the longest amount of time. The durability of efficacy outcomes of robotic Ablatherm-HIFU in the treatment of localized prostate cancer is now established out to eight years. Clinical results obtained using Ablatherm-HIFU were favorable. For a representative number of patients with a minimum of two year follow-up and a maximum of 15 years, the cancer specific survival rate and the freedom from metastatic disease rate were 99% and 97%, respectively, at eight years. In this study, the local control of the disease was achieved with an 85% rate of negative biopsies and a biochemical disease free survival rate (Phoenix criteria) of 83% in low risk cancer patients.

These results build upon those already published in 2006 from a cohort of 297 patients treated with Ablatherm-HIFU at Edouard Herriot Hospital in Lyon, France. The data clearly demonstrates efficacy and stability of Ablatherm-HIFU approach in the treatment of localized prostate cancer.

Dr. Sébastien Crouzet commented, "Ablatherm-HIFU long term results compiled in this study were very positive in terms of efficacy. The clinical outcomes clearly demonstrate stability and efficacy over time using this robotic non-operator dependant approach. Based on these positive findings, Ablatherm-HIFU should be offered to a younger and wider patient population suffering from localized prostate cancer, as it would preserve their quality of life by avoiding risk, such as incontinence and impotence."

Marc Oczachowski, EDAP's Chief Executive Officer, added, "This publication demonstrating Ablatherm-HIFU efficacy and great stability over a long term period represents a major milestone in the HIFU acceptance process as it further validates Ablatherm-HIFU role as a standard of care for the treatment of localized prostate cancer. This further validation will be a key element in helping EDAP market HIFU, create awareness among patients, drive adoption among the clinical community and increase recognition by healthcare authorities."


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 ENLIGHT U.S. clinical study. 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.

CONTACT: EDAP TMS SA Investor Relations / Legal Affairs Blandine Confort +33 4 72 15 31 72 bconfort@edap-tms.com The Ruth Group Investors: Stephanie Carrington 646-536-7017 scarrington@theruthgroup.com