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.

About Insightec

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.

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. INSIGHTEC intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond INSIGHTEC’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. INSIGHTEC does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“Exablate,” “Exablate Neuro,” and “Neuravive” as well as the “INSIGHTEC” logo, whether standing alone or in connection with the word “INSIGHTEC” are protected trademarks of INSIGHTEC


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