InSightec Receives FDA Approval to Begin Phase I Parkinson’s Trial
TIRAT CARMEL, Israel, August 20, 2012 /PRNewswire/ –
InSightec [http://www.insightec.com ] Ltd, the global leader in MR guided Focused
Ultrasound (MRgFUS), announced that it has received approval from the US Food and Drug
Administration (FDA) to begin a Phase I clinical trial evaluating the use of its
ExAblate(R) Neuro [http://www.insightec.com/ExAblate-Neuro.html ] system for the treatment
of patients with tremor dominant Parkinson’s Disease.
Thirty patients who suffer from medication-resistant tremor of Parkinson’s Disease
will be treated in a randomized control trial and followed up for one year.
ExAblate Neuro [http://www.insightec.com/ExAblate-Neuro.html ], pioneered by
InSightec, combines high intensity focused ultrasound for deep accurate lesioning of the
brain, with continuous real-time 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.
The trial will be sponsored in collaboration with the Focused Ultrasound Foundation of
Charlottesville, Virginia. The Foundation has established a brain program to define and
help implement a comprehensive R&D roadmap for brain applications with MRgFUS.
Lead investigator is Dr. Jeff Elias, MD, Director of Stereotactic and Functional
Neurosurgery and Associate Professor of Neurological Surgery and Neurology, University of
Virginia, Charlottesville, Va. Dr. Elias was recently the principal investigator of a
Phase I trial evaluating the use of the ExAblate Neuro for the treatment of essential
InSightec [http://www.insightec.com ] Ltd. is privately held by Elbit Imaging, General
Electric, and MediTech Advisors. Founded in 1999 over $150 million have been invested in
technical and clinical R&D to develop ExAblate transforming 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”.
Media Contact: Lynn Golumbic, InSightec Ltd. +972-4-813-1368 email@example.com
SOURCE InSightec Ltd