Last updated on April 18, 2014 at 10:49 EDT

InSightec’s ExAblate Neuro Receives the Go-ahead from FDA to Begin its Pivotal Phase III trial for Essential Tremor

February 19, 2013

TIRAT CARMEL, Israel, February 19, 2013 /PRNewswire/ –

InSightec Ltd announced that it has received FDA approval to begin its pivotal Phase
III clinical trial for treatment of essential tremor using ExAblate(R) Neuro. This trial
is intended to provide the safety and effectiveness data about the use of ExAblate(R)
Neuro in order to support FDA pre-marketing approval.

ExAblate Neuro uses MR guided focused ultrasound therapy to provide an incision-less
treatment, through the intact skull, with no ionizing radiation. ExAblate MR guided
focused ultrasound (MRgFUS) uses high intensity ultrasound waves to destroy target tissue
in the brain while the patient lies in an MRI, which provides continuous visualization,
plan, guidance, monitoring, and control of the treatment.

Essential tremor is the most common movement disorder which affects millions of people
worldwide. Patients may become severely disabled and have difficulty performing everyday
tasks like drinking, eating, dressing, and writing. More than one third of patients do not
respond to medication, and may consider surgery including implantation of deep brain
stimulating electrodes or radiosurgery with ionizing radiation.

The Phase III study will be a multi-center, double blinded randomized control trial,
with one year followup. Patients who enroll in the trial will be randomized to either
ExAblate treatment or no treatment. The first patients are expected to be enrolled in mid

“We are very excited about the beginning of this pivotal trial for the ExAblate
Neuro.” said Jim Davis, CEO of InSightec. “It offers the hope of improved quality of life
for people suffering with essential tremor. Results from the early studies showed that
patients experienced immediate and durable symptom improvement.”

The trial is based on the safety and initial effectiveness results from 15 patients
treated in FDA feasibility trial sponsored by the Focused Ultrasound Foundation.

“The feasibility study results were highly encouraging. They validated the potential
of focused ultrasound to treat essential tremor patients for whom currently available
medications do not work and surgery is not an option,” said Focused Ultrasound Foundation
Chairman Neal Kassell, MD. “If the pivotal trial confirms early results, it could lead to
the availability of a new, noninvasive treatment option.”

In December 2012 ExAblate Neuro was granted the European CE marking for essential
tremor, tremor dominant Parkinson’s disease and neuropathic pain.


InSightec Ltd. is privately held by Elbit Imaging, General Electric, and MediTech
Advisors. Founded in 1999 InSightec developed ExAblate to transform MR-guided Focused
Ultrasound (MRgFUS) into a clinically viable technology. ExAblate has won several awards
for innovation and its potential to help mankind including The Wall Street Journal
Technology Innovation Awards and the European Union’s IST grand prize. TIME magazine
recently named Focused Ultrasound as “one of 50 best inventions”. For more information
please visit: us.insightec.com and clinicaltrials.gov

        Contact information:
        Lynn Golumbic
        +011972-4-813-1309 or +1866-435-0835

SOURCE InSightec Ltd

Source: PR Newswire