InSightec Starts Pivotal Study of ExAblate(R) to Treat Pain Caused by Bone Metastases

TIRAT CARMEL, Israel, December 17 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemptions (IDE) application that allows the company to launch a Phase 3 pivotal study to determine if its ExAblate(R) incisionless surgery system can safely and effectively reduce the pain associated with bone metastases in patients who have failed to respond to radiation therapy.

The non-invasive, ionized radiation-free magnetic resonance-guided focused ultrasound (MRgFUS) system was approved to treat women suffering from symptomatic uterine fibroids in 2004. Over 3,500 women have already undergone treatment with ExAblate worldwide.

"Pain from tumors that have spread to the bone is the most common kind of pain for cancer patients," notes Dr. Mark Hurwitz of the Dana-Farber/Brigham & Women's Cancer Center at Harvard Medical School and President-Elect of the Society for Thermal Medicine. "While maintaining quality of life for patients with advanced cancer is a top priority, current palliative treatments have several limitations. When pain persists or recurs after palliative radiation, options are often limited as, many patients are too weak to withstand invasive procedures to quell their pain. The ExAblate treatment has shown promising efficacy and safety results in feasibility studies. We look forward to participating in this pivotal study which could provide us with a non-invasive and effective way to improve late-stage cancer patients' quality of life."

Bone is the third most common tissue to which cancer spreads, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases and in breast cancer, bone is the second most common site of metastatic spread, affecting 90% of patients with progressive breast cancer. Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.

Current treatment options for pain control consist of systemic therapy (analgesics, chemotherapy, hormonal therapy and bisphosphonates) and local treatments (radiation, surgery and more recently, Radio Frequency Ablation (RFA)).

Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the tumor to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion. Due to the high acoustic absorption and low thermal conductivity of the bone cortex, it is possible to use a low level of energy and still achieve a localized heating effect while minimizing damage to adjacent tissue.

InSightec expects to enroll 148 subjects with bone metastases who did not respond to radiation treatments into the study, which is expected to take place at 15 centers throughout the U.S. and internationally. The company is in the process of obtaining Institutional Review Board (IRB) approval from each of these sites; including Brigham & Women's Hospital in Boston, Fox Chase Cancer Center in Philadelphia, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College in New York, Mount Sinai in Toronto; the Lahey Clinic in Burlington, Mass.; the Mayo Clinic in Rochester, Minn.; the University of California, San Diego Medical Center in San Diego, Calif.; and Houston Methodist in HoustonTexas.

The ExAblate(R) 2000 system received the European CE Mark certification for pain palliation of bone metastases in June. In clinical studies, which supported the CE mark, the majority of patients reported pain relief within days of treatment.

"We believe ExAblate could pave the way for a new era of incisionless surgery in a range of disease states. Our goal is to help improve millions of lives without the side effects, long hospitalizations, extensive costs, complication risks and long recovery times associated with invasive surgery," said Dr. Kobi Vortman, InSightec's president and CEO. "Approval to launch our first pivotal study in oncology represents a significant milestone in our quest to expand the applications of this innovative therapy. We believe this procedure can alleviate the patient's pain, has the potential to lower reliance on analgesics and provide patients with the opportunity for improved quality of life."

About ExAblate(R) 2000

The ExAblate(r) is the first system to use the breakthrough MRgFUS 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 fully treated and surrounding tissue is spared. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies grand prize, The Wall Street Journal's 2004 Technology Innovation Awards, Advanced Imaging's 2005 Solutions of the Year, the Red Herring 100 Europe 2007 Award and currently one of the World Economic Forum Technology Pioneer 2008.

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 150 employees and has invested more than $100 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

    
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    InSightec Ltd.
    Tel: +972-4-813-1313
    Email: info@insightec.com
    http://www.insightec.com

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