InSightec’s ExAblate Neuro receives the FDA approval for its pivotal phase III trial for essential tremor


InSightec announced on 19 February 2013 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 Food and Drug Administration (FDA) pre-marketing approval, according to a company release.

ExAblate Neuro uses MR guided focused ultrasound therapy to provide an incision-less treatment, through the intact skull, with no ionising 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 visualisation, plan, guidance, monitoring, and control of the treatment.

The phase III study will be a multicentre, double blinded, randomised control trial, with one year follow-up. Patients who enrol in the trial will be randomised 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 Neal Kassell, founder and chairman of Focused Ultrasound Foundation. “If the pivotal trial confirms early results, it could lead to the availability of a new, non invasive treatment option.”

In December 2012 ExAblate Neuro was granted the CE mark for essential tremor, tremor dominant Parkinson’s disease, and neuropathic pain.