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). 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 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-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 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.