A Swiss Team Uses Transcranial MR-Guided Focused Ultrasound to Treat Patients With Functional Brain Disorders

    - Ten-Patient Feasibility Study Shows Safety and Potential for Non-
    Invasive Deep Brain Ablation

    TIRAT CARMEL, Israel, July 14 /CNW/ - InSightec Ltd. today announced that
a team at the University Children's Hospital Zurich has completed a
feasibility study testing the use of non-invasive transcranial MR-guided
focused ultrasound surgery (MRgFUS) for the treatment of neuropathic pain. Ten
adult patients diagnosed with chronic neuropathic pain successfully underwent
non-invasive deep brain ablation surgery (central lateral thalamotomy) with
transcranial MRgFUS and showed improvement in pain scores and reduction of
pain medication with no adverse effects at three months follow-up. This is the
first study in the world to test non-invasive transcranial focused ultrasound
as a treatment modality for functional brain disorders.
    "This study showed that we can perform successful operations in the depth
of the brain without opening the cranium or physically penetrating the brain
with medical tools, something that appeared to be unimaginable only a few
years ago," said Daniel Jeanmonod, neurosurgeon at the University of Zurich.
"By eliminating any physical penetration into the brain, we hope to duplicate
the therapeutic effects of invasive deep brain ablation without the side
effects for a wider group of patients."
    Neurosurgeons currently treat patients with functional neurological
disorders such as neuropathic pain or Parkinson's disease by inserting a tiny
probe through the cranium and brain to reach and ablate damaged tissue.
    "The more traditional invasive treatment works to alleviate pain and
other symptoms, however it exposes the patient to complications, including
infections, bleeding and damage to surrounding brain tissue," Dr. Jeanmonod
explained. "Also, only patients whose target tissue lies in the clear path of
the probe are eligible for the invasive procedure," he said.
    "We now have early clinical evidence suggesting that transcranial MRgFUS
provides a safe and effective way to non-invasively ablate tissue deep within
the brain," said Ernst Martin, M.D., Director of the Magnetic Resonance Center
at the University Children's Hospital Zurich. "While we need to monitor these
patients further, we are very encouraged by the results to date and look
forward to continuing our research. A non-invasive treatment that reduces the
risk of infection and bleeding will fill an unmet need for many patients who
currently have run out of treatment options or are unwilling to undergo
invasive brain surgery because of the risks associated with it."
    One patient in the study suffered nerve damage from a spinal tumour that
led to severe pain and cramps in his right arm. The pain persisted for years
and the patient ultimately reported depression and suicidal thoughts because
of his condition. Immediately after receiving transcranial MRgFUS treatment on
his brain, he reported that the pain had disappeared. A short time later he
was able to resume normal activities that his neuropathic pain had prevented
him from doing, such as gardening and outings in the country with his family.
    The Swiss research team is planning a larger study for functional brain
disorders and expands its clinical research to movement disorders, such as
Parkinson's disease and tremor, and to other functional neurological disorders
later this year. Additional sites in North America are also expected to
initiate clinical research programs in functional brain disorders with
transcranial MRgFUS later this year.

    About ExAblate(R) 4000

    ExAblate is the first system 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 target brain tissue non-invasively. MR thermometry
allows the physician to control and adjust the treatment in real time to
ensure that the targeted area is fully treated and surrounding tissue is
spared. The ExAblate 4000 is a platform for a variety of transcranial
indications, such as brain tumours, functional neurosurgery, stroke and
targeted drug delivery.
    The ExAblate(R) 2000, based on the same technology, was approved by the
U.S. Food and Drug Administration in 2004 as a treatment for symptomatic
uterine fibroids. 5,000 women have been treated worldwide to date. ExAblate
2000 received the European CE Mark certification for pain palliation of bone
metastases in June 2007.

    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
US$150 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

    For more information, read the article
(http://www.nzz.ch/nachrichten/wissenschaft/operieren_ohne_skalpell_1.278089
8.html) which appeared in the Neue Zurcher Zeitung.
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this hyperlink into your Internet browser's URL address field. Remove the
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For further information: Media contact: Hollister Hovey, Lazar Partners,
(646) 871-8482, hhovey@lazarpartners.com