Healthcare Industry News:  Magnetic Resonance guided Focused Ultrasound 

Devices Surgery

 News Release - May 31, 2006

First North American Patient Undergoes MR Guided Focused Ultrasound Surgery to Ease Pain From Bone Metastases

ExAblate(R) 2000 Currently FDA Approved to Treat Uterine Fibroids

HAIFA, Israel, May 31 (HSMN NewsFeed) -- InSightec Ltd. today announced that doctors from the Mount Sinai Hospital and University Health Network (UHN) Joint Department of Medical Imaging in Toronto, Ontario, Canada, have performed North America's first non-invasive surgery using Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) to alleviate pain from bone metastases. The procedure was conducted as a part of a feasibility study being sponsored by InSightec to evaluate the safety and effectiveness of MRgFUS at easing pain caused by bone metastases in patients for whom other available treatment options are neither effective nor feasible.

Bone is the third most common organ to which cancer metastasizes, after the lungs and liver. In breast cancer, bone is the second most common site of metastatic spread, with bone metastases found in 90% of patients dying of breast cancer. Breast and prostate cancer metastasize to bone most frequently, reflecting the high incidence of both of these cancers, as well as their prolonged clinical course.

Pain from bone metastases is the most common cause of cancer pain. 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).

"MRgFUS treatment may offer patients a new hope when other treatment options are not possible or effective, and we look forward to monitoring our first patient's progress and enrolling others," said David Gianfelice, M.D. Associate Professor Abdominal/Interventional Radiology UHN/MSH.

Using the ExAblate 2000 system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's bone 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 prevent him/her from moving around during the procedure. 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 without damaging adjacent tissue.

The patient who was treated suffered from lymphoma and prostate cancer. Prior to treatment he scored 4 on the VAS (Visual Analog Scale), a pain questionnaire used to monitor changes in pain levels and assess the efficacy of pain management.

After treatment the patient returned home. Within 2 days of treatment the patient stopped taking all pain medication and his pain score dropped to 2 on the VAS.

The Mount Sinai - UHN study is being conducted in parallel with similar studies being conducted at Sheba Medical Center in Tel HaShomer, Israel and Charite hospital in Berlin, Germany. To date 17 patients have been treated.

About ExAblate 2000

The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved system to use the breakthrough MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate tissue. MR thermal feedback, 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 received FDA approval for the treatment of symptomatic uterine fibroids in October 2004.

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 Award, and Advanced Imaging's 2005 Solutions of the Year.

About InSightec

InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, private investors 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 130 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:

Source: InSightec

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