The U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication.

Insightec, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication. The Principal Investigator is Howard Eisenberg, MD, Professor of Neurosurgery, University of Maryland School of Medicine, and Chair, Department of Neurosurgery, Raymond K. Thompson, MD Chair in Neurosurgery, University of Maryland Medical Center in Baltimore, Maryland.

Parkinson’s disease afflicts millions of people worldwide, including approximately one million in the United States alone with 60,000 additional diagnoses each year. Treatment with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.

Exablate Neuro uses focused ultrasound to target and ablate tissue deep in the brain with no surgical incisions. MR imaging guides the treatment planning and delivers thermal feedback for real-time monitoring. For Parkinson’s disease, the lesion is made in a portion of the globus pallidus (GPi), which is known to be involved in the regulation of voluntary movement.

“INSIGHTEC remains committed to advancing research to expand indications for our incisionless focused ultrasound technology to improve patient lives,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.

Exablate Neuro became the first focused ultrasound device to receive FDA approval to treat medication-refractory essential tremor in July 2016. Today, there are more than 30 Exablate Neuro systems in 10 countries treating essential tremor patients.

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