Germany is latest - and largest - European country to enable substantial access to focused ultrasound, offering new hope of relief for those suffering with movement disorders

BERLIN, March 4, 2024 /PRNewswire/ -- Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial MR-guided focused ultrasound (MRgFUS) has been granted NUB status 1 for the treatment of essential tremor (ET) in Germany. This significant milestone is set to improve patient access to cutting-edge essential tremor treatments within the German healthcare system.

The Germany Institute for Hospital Remuneration's decision to award NUB status 1 aligns with the Federal Joint Committee's (G-BA) recognition of MRgFUS therapy for ET treatment in 2021[1]. Effective immediately, approved hospitals can negotiate add-on payment within the German national reimbursement system, showcasing the country's commitment to providing innovative solutions.

"Essential tremor, a prevalent movement disorder, affects a substantial part - between 510.000 [2] and 750.000 [3] people - of the German population," says Professor Dr. Günther Deuschl, neurologist at the University Hospital UKSH in Kiel. "While medication can work, some are drug refractory patients who have moderate to severe ET. In these cases, surgery could be the only option."

According to Professor Dr. Helmers, neurosurgeon at the University Hospital UKSH in Kiel, transcranial MRgFUS is a well-established, incisionless surgical procedure than can be offered to patients with drug-resistant essential tremor. "Ultrasound technology delivers targeted therapy to ablate the brain tissue that causes abnormal movements," she says. "Guided by MRI to identify the specific area of the brain, neurosurgeons benefit from real-time monitoring during the procedure."

The decision has major implications for many. "This is a momentous achievement for Insightec and, most importantly, for all the eligible German patients who, until now, had limited access to focused ultrasound treatment for essential tremor," Giuseppe Carbone, vice president of Insightec Europe. "We are proud to bring our innovative solution to Germany and join the efforts of the global community working toward better patient outcomes."

Aymeric Leruste, global head of value and access strategy at Insightec, emphasizes the crucial role that the NUB decision plays in securing the financial viability of offering these essential treatments within the healthcare system. "We are fortunate to finalize the process that started in 2021 when the G-BA first recognized the therapy," he adds.

About Insightec

Insightec is a global healthcare company creating the next generation of patient care by realizing 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 tremor-dominant Parkinson's disease as well as treatment of medication-refractory moderate to severe motor complications of Parkinson's disease as an adjunct to Parkinson's disease medication treatment.

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, with offices in Dallas, Shanghai, and Tokyo.

Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.

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.

[1] https://www.g-drg.de/content/download/13626/file/Aufstellung_Informationen_NUB_DRG_2024.pdf

[2] Song P et al. Global Health Epidemiology Reference Group (GHERG). The global prevalence of essential tremor, with emphasis on age and sex: A meta-analysis. J Glob Health 2021;11:04029.

[3] Deuschl G., Schwingenschuh P. et al., Tremor, S2k-Leitlinie, 2022; in: Deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie. Online: www.dgn.org/leitlinien

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