First U.S. Patient Undergoes MR-Guided Focused Ultrasound Procedure

patient to treat in the company's pivotal trial to evaluate the safety and effectiveness of the system as a pain-relieving treatment for patients with bone metastases who have failed an initial round of palliative radiation.

The ExAblate system, developed by InSightec, Ltd. (Tirat Carmel, Israel), was approved to treat women suffering from symptomatic uterine fibroids in 2004. Over 4,000 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,” said Dr. Kobi Vortman, InSightec's president and CEO. "Many patients are too weak to withstand invasive procedures to quell their pain if it persists or recurs after palliative radiation. We look forward to advancing the trial in hopes that ExAblate may provide a noninvasive, ionized radiation-free means to improve the quality of life of late-stage cancer patients.”

Bone is the third most common tissue to which cancer spreads, after the lungs and liver. Nearly 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.

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 targeted tissue to thermally ablate, or destroy it. The MRI allows the clincian to track 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 hopes to enroll patients with bone metastases who have failed palliative radiation therapy into the study, which is being conducted at 15 sites across the United States. The company is in the process of obtaining Institutional Review Board (IRB) approval from the remaining sites.

The ExAblate 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.

ExAblate is the first system to use the breakthrough MRgFUS technology that combines MRI to visualize the body anatomy, plan 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.

Approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids, 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.

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