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INSIGHTEC'S MRgFUS EARNS POSITIVE NICE GUIDANCE FOR TREATMENT OF ESSENTIAL TREMOR

June 21, 2018
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LONDON, ENGLAND – 20 June 2018 – INSIGHTEC®, a global medical technology innovator of incisionless surgery, announced today that The National Institute for Health and Care Excellence (NICE) issued a positive NICE guidance for unilateral MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor (ET). ET affects more than one million people in the UK and impacts their ability to perform everyday tasks due to uncontrollable shaking of their hands.

 

The Trust Imperial College Healthcare NHS Trust is the first and only site in the UK with the Exablate Neuro™ technology to treat essential tremor. To date 16 patients with ET have been treated at St. Mary's by an expert, multidisciplinary team including Professor Wladyslaw Gedroyc, Consultant Radiologist, Dr. Peter Bain, Consultant Neurologist and Professor Dipankar Nandi, Consultant Neurosurgeon.

 

"Essential tremor patients treated at St Mary's have experienced very substantial improvement in the severity of their tremor as well as their quality of life," commented Professor Dipankar Nandi, Consultant Neurosurgeon and Head of Department, St Mary's Hospital, Imperial College Healthcare NHS Trust. "In addition, the safety profile is favorable with minor, often temporary side effects experienced by this group."

 

During the treatment, ultrasound waves pass safely through the skull to ablate a tiny spot in the brain considered to be responsible for the tremor. The result is often an immediate improvement of the tremor in the treated hand. Due to the incisionless nature of focused ultrasound, there is no risk of infection and patients recover quickly.

 

"The positive NICE guidance adds to the growing body of positive health technology determinations for incisionless brain surgery using INSIGHTEC's Exablate Neuro," said Maurice R. Ferré, MD, Chief Executive Officer and Chairman of the Board of INSIGHTEC. "This is a critical step toward increased patient access to our technology around the globe.” 

 

For more information on the NICE guidance, please visit NICE.org.uk.

 

 

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.

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

 

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

 

Media Contacts:

Sp!der for INSIGHTEC

Jessica Dixon INSIGHTEC@wearespider.com 0207 403 6900

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