InSightec Treats First Prostate Cancer Patients in Clinical Trials

August 31, 2010

ExAblate® MR guided Focused Ultrasound System is being used for the first time for Non-invasive Treatment of Prostate Cancer - Seven Patients with Prostate Confined Low Risk Cancer Treated in Clinical Trials

TIRAT CARMEL, Israel (August 31st , 2010) – InSightec Ltd., the global leader in MR guided focused ultrasound technology and the only company to receive FDA approval for its ExAblate® system for treating uterine fibroids, announced today that its ExAblate® system has been used for the first time for the treatment of prostate cancer patients. Seven patients with localized low-risk prostate cancer were treated worldwide so far. The patients were treated at two leading medical centers: the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia, and at the National Cancer Centre at the Singapore General Hospital, Singapore.

Prostate cancer is one of the most commonly diagnosed cancers among men. According to the American Cancer Society 217,730 new cases of prostate cancer will be diagnosed in the US in 2010; and 900,000 new cases diagnosed globally, according to the World Health Organization. The annual spending in G7 countries (US, UK, France, Italy, Germany, Spain and Japan) is estimated at 15 Billion Dollars. Treatment options include prostatectomy (surgical removal of the prostate gland), radiation therapy, brachytherapy (implantation of radioactive seeds), and cryotherapy. Ultrasound guided high intensity focused ultrasound (HIFU) has also been used, outside the US, to treat prostate cancer.

“Unfortunately current treatment alternatives are accompanied by relatively high levels of adverse events which significantly impact the quality of life of prostate cancer patients. The most common are incontinence and impotence”, says Dr. Kobi Vortman, President and CEO of InSightec. “Due to the introduction of PSA screening tests, prostate cancer is diagnosed at an earlier age thereby increasing the necessity for a treatment option that minimizes adverse events. The ExAblate prostate system has been designed to provide effective treatments while minimizing the debilitating side-effects caused by damage to functional areas of the prostate and neurovascular bundles, thus the system is expected to enable patients to return to normal life within a day or two while maintaining their quality of life.”

The ExAblate system, which has been in clinical use for the treatment of uterine fibroids globally and bone metastases outside of the US, is an Image Guided, Non-invasive, Robotic Acoustic Surgery system integrating real time magnetic resonance imaging to visualize the tumor, surrounding tissue and the energy delivery path together with high intensity focused ultrasound beam which is delivered with millimeter precision to destroy the cancerous tumor without damaging surrounding tissue, which is the cause of most complications. The use of real-time 3D MR thermometry provides accurate closed-loop monitoring of the treatment outcome and ability to adjust the treatment according to specific patient physiology, in real time.

"Current treatment options for low risk prostate cancer patients have shown limited success in preserving potency and continence functions. We believe that with the ExAblate non-invasive procedure we stand a better chance of minimizing life time morbidity without compromising life expectancy", says Associate Professor Christopher Cheng, Head & Senior Consultant, Department of Urology Singapore General Hospital, Singapore.

In the prostate cancer therapy application the major expected benefits of the ExAblate treatment are:
• Low complication rate
• Non-invasive treatment, patients back to their life within a day or two
• Non-ionized radiation
• Single session therapy
• Real time MR thermometry monitoring that is used to control treatment outcome during treatment

“We are very pleased to have been the first facility to adopt the ExAblate system for Phase 1 prostate cancer clinical trials.” said principle investigator Professor S.V. Kanaev, Chairman of Radiation Oncology, N.N Petrov Research Institute of Oncology. “We have had excellent results with ExAblate in treating patients suffering from bone metastases and we believe it has tremendous potential in treating prostate cancer patients with a low complication rate. We and our patients have been very pleased with the results achieved to date.”

InSightec will shortly be expanding the prostate clinical trials to additional leading sites globally.

About InSightec
InSightec Ltd. is a privately-held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/

About ExAblate®
ExAblate is an Image Guided, Non-invasive, Robotic Acoustic Surgery system. The ExAblate system is the first to use the MR guided focused ultrasound technology that combines MRI – to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time – and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is treated and surrounding non targeted tissue is spared. The ExAblate system was approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids. Over 6,000 women have been treated worldwide to date with excellent results. ExAblate® 2000 received the European CE Mark for pain palliation of bone metastases in June 2007 and for Adenomyosis in June 2010.


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