The U.S. Food and Drug Administration (FDA) has approved the initiation of a clinical study using the company’s MR-guided Focused Ultrasound (MRgFUS) to treat patients with Alzheimer’s disease (AD).
HAIFA, Israel and MIAMI, July 25, 2018 /PRNewswire/ — Insightec®, a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of a clinical study using the company’s MR-guided Focused Ultrasound (MRgFUS) to treat patients with Alzheimer’s disease (AD).
“It is exciting to lead this pioneering study to evaluate focused ultrasound for Alzheimer’s disease,” said Ali Rezai, MD, Executive Chair, West Virginia University Rockefeller Neuroscience Institute. “The potential for blood brain barrier (BBB) disruption to aid in the clearance of beta-amyloid holds promise for developing new and innovative treatments that are crucial in the battle against Alzheimer’s and other neurodegenerative diseases.”
The study is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of using Insightec’s Exablate Neuro low-frequency focused ultrasound to disrupt the BBB in patients diagnosed with AD.
“Insightec is spearheading clinical research by collaborating with leading researchers to advance brain health,” said Maurice R. Ferré, MD, Chief Executive Officer and Chairman of the Board of Insightec. “We remain sharply focused on making a profound impact on the health and lives of people across America and around the globe.”
An early trial using the company’s Exablate Neuro to temporarily disrupt the BBB has been completed on five patients with early stage AD at Sunnybrook Health Sciences Centre in Toronto, Canada. The results by lead investigator, Dr. Nir Lipsman, were published in Nature Communications on July 25, 2018.
Insightec® is a global medical technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company’s award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment to deliver immediate and durable tremor relief for essential tremor patients. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, Florida, with offices in Dallas, Tokyo and Shanghai.
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