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

Food and Healthcare Press Releases Friday October 27, 2017 07:36
HAIFA, Israel--27 Oct--PRNewswire/InfoQuest

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. 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

Latest Press Release

Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

- FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer - First regulatory designation for M7824 following recent presentation of first clinical data in BTC - BTC is a group of rare, aggressive...

Merck in Agreement With Cyclica for AI-augmented Screening Platform to Expand Research Capabilities

- Agreement to screen discovery and early development compounds using artificial intelligence and computational biophysics - Cloud-based in silico platform that screens small molecules to determine polypharmacological profiles - Evaluation to include...

Vitality-linked Insurers to Get 100 million People 20% More Active by 2025

Building on the results of the largest behaviour change study on physical activity, Vitality and its global network of insurers have collectively committed to improving the health of millions over the next seven years. This is in line with the World...

World Congress of Cardiology Cardiovascular Health 2018 Opens in Dubai

- Professor David Wood, President of the World Heart Federation, welcomes more than 5000 cardiologists, doctors, nurses, and health and policy experts from around the world to Dubai for WCC 2018 at a time when the opportunities for a sustainable impact...

Data Presented at 2nd Healthy Lung Summit 2018 to Demonstrate Impact of AstraZeneca#s Healthy Lung Partnership Programme

Deepening commitment to drive improvements for patients with respiratory disease across Asia, AstraZeneca with Business Sweden, The Swedish Trade & Invest Council in Taiwan, hosts the second Healthy Lung Summit, ahead of the 2018 Asia Pacific Society...

Related Topics