Insightec continues to lead the Focused Ultrasound market with new FDA approval of five-year data demonstrating efficacy for Essential Tremor, without progressive or delayed complications

• Significant and sustained tremor improvement at five years
• No new adverse events related to the procedure were reported from the 12-month timeframe to the last follow up at five years
• Participants reported overall improvement in quality-of-life measures with no progressive or delayed complications
• A clinically meaningful 73.1% improvement in tremor severity, consistent with previously published data
• Study results published in Journal of Neurosurgery, following the original 2016 paper in New England Journal of Medicine

HAIFA, Israel and MIAMI, July 20, 2023 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using focused ultrasound (FUS) technology to transform patient care, today announced FDA approval of the five-year study endpoint for the largest prospective long-term, follow-up study of unilateral MR-guided focused ultrasound (MRgFUS) surgery (thalamotomy) for essential tremor (ET) to date. The data shows sustained and significant tremor improvement at five years with an overall improvement in quality-of-life measures and without any progressive or delayed complications. The study also confirms the long-term efficacy of the procedure for sufferers of ET, and follows the recent FDA approval of use of the technology to treat the second side tremor of appropriate patients. Insightec's Focused Ultrasound technology has been used to perform over 11,000 procedures worldwide.

"The FDA approval validates the years of work that we have invested into using Focused Ultrasound as a front-line therapy for ET," said Maurice R. Ferré, MD, CEO and the Chairman of the Board of Directors at Insightec. "It also substantiates that using MR-guided focused ultrasound to treat essential tremor is safe and effective, as well as long-lasting. We look forward to making further progress in finding more uses for focused ultrasound and building on the success of the treatment of essential tremor." 

The randomized, controlled, multi-center study describes the long-term safety and efficacy of unilateral MRgFUS thalamotomy for the treatment of medication-refractory essential tremor using the Exablate System. 

The data showed the durability of tremor reduction in patients' (n=40) treated hand, which remained significantly improved at five years. This 73.1% improvement in tremor severity (CRST Part A) is considered clinically meaningful and is consistent with previously published data from this cohort. 

Importantly, quality of life (QUEST) and functional disability (CRST Part C) also remained sustained from baseline. In addition, no new adverse events related to the procedure were reported from the 12-month timepoint to the last follow-up at 5 years.  

"Being part of the clinical study 7 years ago was life changing," says Alexandra Lebenthal, a clinical trial Focused Ultrasound patient from 2016. "I have been able to focus on life and my career every day without needing to work around and hide my tremor. I'm looking forward to having my other hand treated soon."

About Insightec 

Insightec is a global healthcare company dedicated to using focused ultrasound technology to transform patient care. The company's Exablate platforms focus sound waves, safely guided by MRI, to provide tremor treatment to patients with a variety of conditions, including medication-refractory Essential Tremor, Parkinson's Disease, and prostate disease. Insightec is working in partnership with leading academic and medical institutions on research for future applications in the neuroscience space and beyond. Insightec is headquartered in Haifa, Israel and Miami, Florida, with offices in Dallas, Texas, Shanghai, China and Tokyo, Japan. 

For more information, visit www.insightec.com, or Facebook, LinkedIn and Twitter. 

Forward-looking Statements: 

This document contains forward-looking statements regarding, among other things, plans, expectations, and future events. 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. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. Any forward-looking statement is based on information available to Insightec as of the date of the statement. All written or oral forward-looking statements attributable to Insightec are qualified by this caution. Insightec does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Insightec's expectations. 

"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. 

Insightec Media Contact: 
G&S Business Communications for Insightec 
Marjani Williams 
mwilliams@gscommunications.com  
(312) 648-6700, ext.2108 

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SOURCE Insightec