InSightec's ExAblate Neuro Receives the Go-ahead from FDA to Begin its Pivotal
Phase III trial for Essential Tremor
TIRAT CARMEL, Israel, 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®
Neuro. This trial is intended to provide the safety and effectiveness data
about the use of ExAblate® Neuro in order to support FDA pre-marketing
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 2013.
"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
The trial is based on the safety and initial effectiveness results from 15
patients treated in FDA feasibility trial sponsored by the Focused Ultrasound
"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
+011972-4-813-1309 or +1866-435-0835
SOURCE InSightec Ltd
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