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 and Pfizer Provide Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

Merck and Pfizer Inc. (NYSE: PFE) today announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab* to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after...

PharmaMar Licenses Fully Synthetic Marine-derived Payloads to Seattle Genetics for Use in Drug Conjugates

PharmaMar (MCE: PHM) has announced today the signing of an exclusive licensing agreement with Seattle Genetics Inc. (SGEN: NASDAQ GS) under which Seattle Genetics receives exclusive worldwide rights to certain PharmaMar proprietary molecules for the...

After multiple failed procedures at other medical institutions, Colorado man successfully treated for Atrial Fibrillation at Texas Cardiac Arrhythmia Institute at St. David#s Medical Center

"I was thinking I was on top of the world," Wiseman said. "I was keeping myself in shape. I was taking care of myself mentally and physically. My relationship was solid." Then, during a routine medical exam while serving in the military in California,...

World#s Leading Health Organizations Release Third Edition of Widely Used Resource on Family Planning

Global Handbook Gives Health-Care Providers Accurate and Practical Guidance for Counseling Clients Family planning is considered a development "best buy" and a life-saving intervention for millions of women and girls. Crucial to the success of family...

ไฟเซอร์ ประเทศไทย สนับสนุนงานประชุมวิชาการด้านโรคมะเร็ง

แผนกมะเร็งวิทยาของบริษัท ไฟเซอร์ (ประเทศไทย) จำกัด (Pfizer Oncology) ให้การสนับสนุนการจัดงานประชุมวิชาการ 'The 5th Ramathibodi-Mayo Clinic Joint Conference: Best Practice in Oncology 2018' ช่วง Lunch Symposium' ในหัวข้อ Continuum of care for ALK positive...

Related Topics