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Last updated on April 17, 2014 at 10:34 EDT

Enrollment in First MRgFUS Essential Tremor Feasibility Trial Completed

January 3, 2012

TIRAT CARMEL, Israel, January 3, 2012 /PRNewswire/ –

InSightec Ltd, the global leader in MR guided Focused Ultrasound (MRgFUS) therapy,
announced today that it has completed enrollment in the world’s first feasibility study
[http://www.clinicaltrials.gov/ct2/show/NCT01304758?term=ExAblate&rank=4 ] evaluating the
use of MRgFUS for treatment of Essential [http://www.insightec.com/Essential_Tremor.html ]
Tremor, using ExAblate(R) Neuro at University of Virginia
[http://www.medicine.virginia.edu/clinical/departments/radonc/focused-ultrasound/technology ]
, Charlottesville, Virginia.

Fifteen patients underwent a non-invasive ExAblate treatment to evaluate safety and
initial effectiveness of this investigational device. Most patients, who suffered for at
least 10 years, experienced tremor improvement and no severe adverse events. They are
being followed up for three months. Patient videos can be viewed here:
http://bit.ly/sRpXno , http://bit.ly/tWaOl3

ExAblate Neuro, pioneered by InSightec, combines high intensity focused ultrasound for
deep accurate lesioning of the brain, with continuous realtime MR guidance for visualizing
brain anatomy, planning and monitoring treatment and outcome. The lesioning is performed
through an intact skull with no incisions or ionizing radiation.

Additional research using MRgFUS for chronic neuropathic pain
[http://www.insightec.com/Neuropathic_Pain.html ],targeted drug delivery
[http://www.insightec.com/Brain_Preclinical_research.html ], and sonothrombolysis for acute
ischemic stroke [http://www.insightec.com/Brain_Preclinical_research.html ] is described
in the January issue of Neurosurgical Focus [http://thejns.org/toc/foc/current ] devoted
to MR guided focused ultrasound applications for central nervous system disorders.

“The safety profile of ExAblate Neuro and initial clinical efficacy are extremely
encouraging” said Dr. Jeff Elias, principal investigator, Director of Stereotactic and
Functional Neurosurgery and Associate Professor of Neurological Surgery and Neurology,
UVA. Dr. Elias presented interim results at the European MRgFUS symposium in Rome
(http://bit.ly/sVntp3) and at the Congress of Neurological Surgery in Wash DC.

Essential tremor, a very common movement disorder, affects millions of people
worldwide. They have difficulty performing everyday tasks like drinking, eating, dressing,
and writing. One third do not respond to medication, and may consider surgery. These have
well recognized risks: high doses of ionizing radiation, complications and side effects
from invasive surgery.

MRgFUS was investigated as an alternative for these medically refractory patients.

“ExAblate Neuro, the only MRgFUS brain system in clinical use, has demonstrated the
ability to ablate targets deep in the brain with high precision. Encouraging initial
results provide hope that this treatment could become a significant addition for treating
neurological disorders”, said Eyal Zadicario, VP of R&D and Director of InSightec’s Neuro
program. “InSightec is expanding its Neuro research, to include brain tumors, stroke and
targeted drug delivery.”

About InSightec

InSightec Ltd. is privately held by Elbit Imaging, General Electric, and MediTech
Advisors. Founded in 1999 over $150 million have been invested in clinical and technical
R&D to develop ExAblate using MR guided Focused Ultrasound into a clinically viable
technology. ExAblate has won several awards for innovation and its potential to help
mankind including the Wall St. Journal Technology Innovation Awards and the European
Union’s IST grand prize. TIME magazine recently named Focused Ultrasound as “one of 50
best inventions”.

Dr. Yoav Medan, InSightec’s Chief Systems Architect, presented MRgFUS at TEDMED
[http://www.insightec.com/tedmed.html ] 2011. (http://bit.ly/sII9CT)

        Media Contact:
        Lynn Golumbic
        +972-4-813-1380
        lynng@insightec.com

SOURCE InSightec Ltd


Source: PR Newswire