Phase I Study of High Intensity Focused Ultrasound Using the Sonablate 500 in Patients with Locally Recurrent Prostate Cancer

U.S. HIFU, LLC along with trial sponsor, Focus Surgery, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted approval to initiate a clinical trial for locally recurrent prostate cancer utilizing High Intensity Focused Ultrasound (HIFU) with the Sonablate® 500. Recurrent prostate cancer is cancer that returns after the patient has received initial treatment for cancer.

The study will be conducted at Indiana University School of Medicine by principal investigators Dr. Michael Koch and Dr. Tom Gardner. A second trial site will be announced soon.

Patients who have had cancer return after receiving external beam radiation therapy (EBRT) or brachytherapy for prostate cancer are potential candidates for study enrollment. For more information about enrollment as a study subject contact U.S. HIFU at 1-888-874-4384.

HIFU with the Sonablate® 500 uses sound waves to destroy the tissue of the prostate gland by rapidly heating the targeted area in a matter of seconds. The procedure delivers HIFU energy with a transrectal ultrasound probe and is usually preformed on an out-patient basis with an epidural anesthetic.

Although still in clinical trials in the U.S., the Sonablate® 500 is already approved in many countries including Europe and Canada for the treatment of localized prostate cancer and benign prostate hyperplasia (BPH).

Prostate cancer is the most common type of non-skin cancer in American men and the second leading cause of death in men. The American Cancer Society estimates that there were about 230,900 new cases of prostate cancer in the U.S. in 2004 and that 30,000 men die from the disease each year.

Media can contact Karen Ammond, Publicist- 856-869-9403