InSightec Ltd., a privately held Israeli company partly owned by General Electric Corp., announced on Tuesday that its flagship product, the ExAblate Neuro, will enter Phase III clinical testing for essential tremor, a progressive neurological condition.

The pivotal Phase III trial will determine whether the U.S. Food and Drug Administration will support pre-market approval of the device for the condition.

ExAblate Neuro uses MR-guided focused ultrasound therapy, a non-invasive treatment performed through the skull. According to a statement from the company, ExAblate MR-guided focused ultrasound uses high-intensity ultrasound waves to destroy target tissues in the brain while the patient lies in an MR scanner to help the clinician guide and monitor the treatment.
MR-guided focused ultrasound is said to have immediate effects for a condition like essential tumor that involves ablation of a nearby part of the brain with no ionizing radiation.

The initial trials using ExAblate Neuro to treat essential tumor were conducted at the lead test site at the University of Virginia in Charlottesville in an 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 Dr. Neal Kassell in a statement. "If the pivotal trial confirms early results, it could lead to the availability of a new, noninvasive treatment option."

ExAblate Neuro is also installed in the U.S. at Brigham and Women's Hospital in Boston and the University of California, San Diego.

According to InSightec, the Phase III study will be a multi-center, double blinded randomized control trial set to begin in mid 2013. Patients who enroll in the trial will be randomized to either ExAblate treatment or no treatment and will be followed up after one year.

Treating essential tremor is just one of many uses under investigation for the ExAblate family of devices of MR-guided focused ultrasound products. In late August, InSightec got the go-ahead from the FDA to proceed with a phase I trial of a Parkinson's treatment that uses ExAblate MR-guided focused ultrasound.

Not to be confused with Parkinson's disease, essential tremor is characterized by rhythmic trembling of the hands, head, voice, legs or torso and affects over 10 million Americans, according to the American Academy of Neurology.

Other applications being studied for ExAblate MR-guided focused ultrasound include blasting cancers and bone metastases.

In December 2012, ExAblate Neuro received European CE marking for essential tremor, tremor dominant Parkinson's disease and neuropathic pain.

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