MUNICH, Germany, Sept. 12, 2023 /PRNewswire/ -- Insightec, a global healthcare company specializing in magnetic resonance guided focused ultrasound (MRgFUS), today announced that it has received another brand approval CE for the treatment of essential tremor using its Exablate Neuro platform.

Essential tremor typically affects both sides of the body, and this new CE mark approval will allow suitable patients to receive treatment on the contralateral side at least nine months after the first, potentially relieving tremor on both sides. of the body. Approximately 60 million people worldwide suffer from essential tremor, which is frequently misdiagnosed as Parkinson's disease, making it the most common motor disorder in the world.

Treatment effectiveness. The Insightec-sponsored study included patients from a multicenter randomized clinical trial for unilateral treatment who qualified for the bilateral procedure. Study data demonstrated a highly significant reduction in tremor after treatment of the contralateral side. These results were immediate and sustained, at least over a six-month follow-up, consistent with the first-side treatment results. Additionally, there was a significant improvement in functional disability, suggesting that there is a clinically significant effect on activities of daily living, such as eating, drinking, and writing. Most adverse effects were mild, with a profile similar to the treatment on the contralateral side.

"This CE Mark approval is a very important milestone for us and demonstrates our unwavering commitment to expanding treatment options that can improve the quality of life for people suffering from essential tremor," said Maurice R. Ferré, MD, CEO and Chairman of the Board of Directors of Insightec. «Many patients, who have benefited from tremor reduction with treatment on the first side, have requested treatment on the contralateral side. This approval opens the way for them to receive it.

“Since its approval in the United States, patients and doctors in Europe have been eagerly awaiting its availability,” explained Giuseppe Carbone, Insightec Vice President, Europe. "With this approval, patients can potentially avoid having to choose which side they want to receive treatment for." “It is very exciting to be able to offer the complete treatment and allow people who suffer from essential tremor to feel whole.”

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About Insightec

Insightec is a global healthcare company creating the next generation of patient care by harnessing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to deliver treatment to patients with drug-resistant essential tremor and Parkinson's disease. There is ongoing research for future applications in the field of neuroscience, in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, and has offices in Munich, Dallas, Shanghai, and Tokyo.

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Forward-looking statements:

This document contains forward-looking statements regarding, among others, plans, expectations and future events. In some cases, forward-looking statements can be identified by the use of the following words: "may", "could", "will", "would", "could", "should", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "project", "potential", "promise", "continue", "permanent," or the negative of the previous terms. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ from those expressed or implied in the statements. All forward-looking statements are based on information available to Insightec as of the date of the statement. All written or oral forward-looking statements attributable to Insightec are subject to this cautionary statement. Insightec undertakes no obligation to update or revise any forward-looking statements to reflect changes in circumstances or Insightec's expectations.

“Exablate” and “Exablate Neuro”, as well as the “INSIGHTEC” logo, alone or in conjunction with the word “Insightec”, are protected trademarks of Insightec.

Insightec media contact:Andrea Montaroloandrea.montarolo@eurosagency.eu 32 492 27 24 87

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