EDAP TMS Gets CE Mark For Proprietary HIFU Technology

EDAP TMS S.A. announced that it has received the CE Mark for its proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of localized prostate cancer. The CE Mark is the European equivalent to an FDA approval and allows the company to market its HIFU technology utilized through the company's medical device, the Ablatherm, throughout Europe.

The Ablatherm's minimally-invasive technology utilizes a focused ultrasound beam to destroy well-defined tumors without affecting the surrounding tissue. Clinical studies show that the lower morbidity rate and the minimally invasive nature of this treatment - no incision, no needles, no radioactive seeds - makes it very acceptable to the patient and represents a valid treatment alternative for patients with localized prostate cancer, who are unsuitable for surgery.

Eric Simon, president and CEO of EDAP TMS, commented, "Receipt of the CE Mark for our HIFU technology represents a critical milestone in our effort to help treat the growing number of patients suffering from localized prostate cancer. After several years of research, development and clinical studies we are pleased to offer the European urology community the Ablatherm, which is proven to be a safe and efficient device for treating patients with prostate cancer. "

Dr. Guy Vallencien, chief of the Urology Deparment, Institut Mutualiste Montsouris,(Paris, France), added, "Studies show that HIFU technology has a proven ability to destroy cancer cells. Approval of the Ablatherm will allow urologists to further demonstrate the efficacy of this exciting technology, benefiting doctors and patients requiring a treatment alternative valued for its ease of use, repeatability and minimally invasive technique."

In addition, the company also announced that the Ablatherm will be exhibited at the second International Consultation on Prostate Cancer, sponsored by the World Health Organization, in Paris, June 27 through June 29. The event includes a symposium, chaired by Dr. Alain Le Duc of Saint Louis Hospital, Paris, who will present the latest results of several different studies performed in Europe further supporting the efficacy of HIFU technology.