A Swiss Team Uses Transcranial MR-Guided Focused Ultrasound to Treat Patients With...

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 /PRNewswire/ -- 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 tumor 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 tumors, 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 $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 which appeared in the Neue Zurcher
Zeitung.
Media Contact:

Hollister Hovey
Lazar Partners
+1-646-871-8482
hhovey@lazarpartners.com

SOURCE InSightec Ltd.

Hollister Hovey, Lazar Partners, +1-646-871-8482, hhovey@lazarpartners.com