Insightec’s Exablate 2000 is a non-invasive system that aims focused ultrasound waves at a tumor to destroy it.For late-stage cancer patients one of the most common kinds of pain is from tumors that have spread to the bone. Current pain treatments are too limited, and options are few, because the patients are often too weak to withstand invasive procedures that quell this pain.

Now an Israeli-developed ultrasound treatment could have the answer. Exablate 2000 is a non-invasive, magnetic resonance-guided focused ultrasound surgery system that thermally ablates, or destroys, tumors inside the body. Developed by Tirat Carmel company Insightec, it has already been approved for treatment of women suffering from uterine fibroids – a pervasive condition that impacts up to 70 percent of childbearing age women and leads to serious symptoms and complications. Since 2004, when it received FDA approval, some 3,500 women around the world have undergone treatment.

Insightec expects to enroll 148 patients with bone metastases for the new clinical trial which is expected to take place at 15 centers across the US and abroad, including hospitals in Boston, Philadelphia, New York, Rochester, San Diego, Houston, Burlington, and Toronto. The company is now obtaining Institutional Review Board (IRB) approval from each of these sites.

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 percent of patients with progressive breast cancer. Most cancer patients suffer from pain and its control and management is an important goal of treatment.

Current therapy for pain control includes systemic therapy – analgesics, chemotherapy, hormonal therapy and bisphosphonates, and local treatments – radiation, surgery and more recently, radiofrequency ablation.

With Exablate, the doctor uses magnetic resonance imaging (MRI) to visualize the patient’s anatomy and then aims focused ultrasound waves at the tumor to destroy it. The MRI allows the physician to monitor and continuously adjust treatment in real time to ensure that only the tumor is treated and surrounding tissue spared. 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.

“Approval to launch our first pivotal study in oncology represents a significant milestone in our quest to expand the applications of this innovative therapy,” said Dr. Kobi Vortman, Insightec’s president and CEO.

The Exablate system has already received the European CE mark certification for pain relief of bone metastates in June last year. Clinical studies for this certification showed that most patients reported pain relief within days of treatment.

“Pain from tumors that have spread to the bone is the most common kind of pain for cancer patients,” according to Dr. Mark Hurwitz of the Dana-Farber/Brigham and Women’s Cancer Center at Harvard Medical School and president-elect of the Society for Thermal Medicine. “The Exablate treatment has shown promising efficacy and safety results in feasibility studies. We look forward to participating in this study which could provide us with a non-invasive and effective way to improve late-stage cancer patients’ quality of life.”

Insightec was founded in 1999 by Vortman and Oded Tamer. The company is headquartered near Haifa and has over 150 employees. It has invested more than $100 million in research, development, and clinical investigations. US headquarters are located in Dallas, Texas. The company is privately owned by Elbit Imaging (EMI), General Electric, Ameritech Advisors, LLC and employees.

Last month the company was selected by the World Economic Forum as a Technology Pioneer for 2008. Chosen from a pool of 273 nominees, it was picked for innovation in developing and applying technologies deemed highly transformational in the area of health.

World Economic Forum criteria for Technology Pioneers includes development of life-changing technology innovation, potential for long-term impact on business and society and demonstrated visionary leadership qualities.

“We’re pleased that the World Economic Forum has recognized Exablate’s potential with this prestigious designation,” said Vortman. “We believe this non-invasive technology has the potential to become one of the major forms of surgery within the next 20 years, helping improve millions of lives without the long hospitalizations, extended recovery times, side effects, complication risks and extensive costs associated with invasive surgery.”

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