HIFU Technology

High Intensity Focused Ultrasound (now called HIFU) was first used in 1987 to determine if it could be used to ablate or destroy prostate tissue. HIFU is similar to the light passing through a magnifying glass to a sharp focal spot a predetermined distance away from the lens.

Similar to the magnifying lens, the ultrasound energy is focused through a transducer lens to a set distance (3.0cm or 4.0cm) from the transducer face. Converging ultrasound energy waves of high intensity generate tremendous energy increases in the focal spot driving temperatures up to 70 -100 o C in less than one second. The tissue is destroyed within 3 seconds and the energy is turned off. The system then begins to overlap these focal spots on each other back and forth throughout the prostate until the entire gland is destroyed.

The process can take between 1-3 hours depending on the size of the prostate. The tissue is destroyed by thermal damage, or ablation. The dead tissue then sloughs out through urination and through the absorption of fluid and tissue by the body. The energy is transmitted through a unique transrectal probe that both images and provides the therapy in a single lens. This allows the doctor to have real-time control over the treatment, and the confidence that what he is seeing is being destroyed.

HIFU energy is clean, precise, repeatable therapy for prostate diseases. There is no bloodloss, no hospital stay required, one-visit treatment (unless retreatment required), and has minimal long term side effects.

Therapeutic Benefits	HIFU	Radiation Therapy	Brachy Therapy	Surgery
Minimally Invasive	Yes	Yes	Yes	No
Early Feedback	Yes	No	No	Yes
Quality of Life	High	Medium	Medium	Low
Precise	Yes	No	Yes	Yes
Repeatable	Yes	No	No	No
Low Complications	Yes	No	Yes	No
Bloodloss	No	No	No	Yes

Prostate Cancer - Over 1,200 patients have been treated at 32 sites worldwide for localized prostate cancer with the Sonablate® 500. Follow-up of over 180 patients reveals:

Clinical Results
181 Patients:	21 mos. (Mean Follow Up Period)
ASTRO Success:	94% (For Pre-PSA < 10ng/ml) 86% (For Pre-PSA < 20ng/ml)
Complications:	0.6% Incontinence 20% Impotence (25% of these recovered with Viagra™)
Results at JEE 2004 Prostate Cancer Symposium, Dr. T. Uchida, Tokai University

Prostate cancer clinical studies are complete in Japan , and ready to begin Phase II/III in the U.S. The device has CE Mark approval in Europe for the treatment of prostate diseases.

Benign Prostatic Hyperplasia - As an outpatient procedure, BPH (benign prostatic hyperplasia) patients obtained 72% improvement in symptom scores and flow rate improvements of 52%, without long-term complications. The treatment requires only 30-60 minutes to perform, and has been used for the treatment of over 1,500 BPH patients. The procedure is approved in Japan and in Europe under CE Mark.

Developed in close partnership with Indiana University Medical Center over the past 10 years, over 70 doctors around the world have used the Sonablate® system for the treatment of prostate cancer and BPH. Over 800 patients have been treated for prostate cancer using the Sonablate® and over 1,600 patients for symptomatic relief from BPH (benign prostatic hyperplasia).