INSIGHTEC Receives FDA Approval to Initiate Pivotal Study of Exablate Neuro for the Treatment of Patients with Parkinson's Disease

PR70732

HAIFA, Israel, October 26, 2017 /PRNewswire=KYODO JBN/ --

    INSIGHTEC [http://www.insightec.com ], 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. Ferre 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.

    About INSIGHTEC

    INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound

(MRgFUS). The company's non-invasive platforms, Exablate and Exablate Neuro,

are proven technology based on sound clinical evidence for treating essential

tremor, painful bone metastases and uterine fibroids. The company is dedicated

to improving patient lives by collaborating with physicians, medical

institutions, academic researchers and regulatory bodies around the world.

    For more information, please visit: http://www.insightec.com.

    Media Contact:

    Michelle Barry

    Red Lorry Yellow Lorry for INSIGHTEC

    insightec@rlyl.com

    +1-(857)-217-2886

Source: INSIGHTEC