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COMUNICADO: INSIGHTEC MR-GUIDED FOCUSED ULTRASOUND TECHNOLOGY RECOMMENDED FOR NATIONAL COVERAGE FOR DUTCH PATIENTS LIVING WITH ESSEN

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COMUNICADO: INSIGHTEC MR-GUIDED FOCUSED ULTRASOUND TECHNOLOGY RECOMMENDED FOR NATIONAL COVERAGE FOR DUTCH PATIENTS LIVING WITH ESSEN

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The Netherlands is the latest European country to recommend national coverage for the treatment of essential tremor with focused ultrasound.

AMSTERDAM, Jan. 29, 2024 /PRNewswire/ -- Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) to have MR-guided focused ultrasound (MRgFUS) reimbursed for people suffering from essential tremor (ET). This recommendation is a pivotal moment, paving the way for nation-wide access to focused ultrasound treatment for essential tremor.

Released to the public on the public on December 18, 2023, the ZIN recommendation concludes that MRgFUS (also called high-intensity focused ultrasound, or HIFU) which was pioneered by Insightec, is an effective treatment for patients with moderate to severe medication-refractory essential tremor who are not suitable for deep brain stimulation. It also concludes that these patients should therefore be included in the national basic health insurance package, which would guarantee patient access to the therapy. The report was produced following a request submitted by Amsterdam UMC in early 2023 with the support of Dutch medical societies, including the Dutch Association for Neurosurgery (NVvN) and the Dutch Association for Neurology (NVN).

"This is an important day not only for us at Insightec, but also for over 17 million Dutch residents who could not have access to focused ultrasound treatment for essential tremor so far," says Maurice Ferré, M.D., CEO and chairman of the board of Insightec. "We are delighted to welcome the Netherlands in the growing club of countries that secure patient access to MRgFUS."

According to an Insightec study, patients experienced significant reductions in upper limb tremor, tremor-related disability, and quality of life. The most common intraprocedural adverse events included dizziness, headache, nausea, and vomiting, which all resolved. Post-procedural adverse events included paraesthesia and gait disturbance, which were often transient or resolved within 12 months.[2]

About MRgFUS. MR-guided focused ultrasound (MRgFUS), an effective, non-invasive treatment option for essential tremor. MRgFUS uses specialised ultrasound technology to deliver targeted brain therapy without an incision to ablate the brain tissue that causes abnormal movements. Guided by MRI to target the specific area of the brain, neurosurgeons benefit from real-time, detailed images of the brain for precise localisation and monitoring during the procedure.

About Essential Tremor. Essential tremor (ET) is the most common movement disorder[3]. It is characterized by an isolated upper limb action tremor of at least three years' duration without other neurological signs, although some patients may exhibit a range of other symptoms and signs.

[1] https://www.zorginstituutnederland.nl/publicaties/standpunten/2023/12/12/standpunt-hifu[2] MSAC Public Summary Document. Application No. 1614 – Magnetic resonance-guided focused ultrasound for the treatment of medically refractory essential tremor. Insightec Ltd. Available at http://www.msac.gov.au/internet/msac/publishing.nsf/Content/17E39DC9F1DE6FB4CA25850B00045325/$File/1614 Final PSD - Mar-Apr 2021_redacted.pdf (accessed August 2023)[3] Louis ED, McCreary M. How Common is Essential Tremor? Update on the Worldwide Prevalence of Essential Tremor. Tremor and Other Hyperkinetic Movements. 2021; 11(1): 28, pp. 1–14. DOI: https://doi.org/10.5334/tohm.632

About Insightec

Insightec is a global healthcare company creating the next generation of patient care by realising the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson's Disease. 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, USA, with additional offices in Dallas, Shanghai, and Tokyo.

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.

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