INSIGHTEC RECEIVES FDA APPROVAL TO BEGIN PHASE I PARKINSON’S TRIAL
Tirat Carmel, Israel (August 20, 2012). 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.