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InSightec Receives FDA Approval to Begin Phase I Parkinson's Trial


8/20/2012 10:50:06 AM

TIRAT CARMEL, Israel, August 20, 2012 /PRNewswire/ --

InSightec 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® Neuro 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, 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 tremor.

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 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
lynng@insightec.com


SOURCE InSightec Ltd



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