Haifa, Israel – January 23, 2020 – Insightec, a global medical technology innovator of incisionless surgery, has received a Pre-Market Approval (PMA) for its Exablate Neuro (Device name: MR guided Focused Ultrasound Surgery system – ExAblate 4000, Approval number: 22800BZI00040000) from the Japanese Ministry of Health Labor and Welfare (MHLW). The approval for Exablate Neuro now extends to targeting the thalamus for treating Tremor-dominant Parkinson’s Disease, and the Globus pallidum for treating advanced Parkinson’s Disease patients suffering from mobility, rigidity, or dyskinesia symptoms.

“This approval adds focused ultrasound as an incisionless surgical option to treat Parkinson’s disease,” commented Professor Takaomi Taira, Director of Stereotactic and Functional Neurosurgery, Department of Neurosurgery, Tokyo Women’s Medical University (TWMU), Tokyo, Japan. “Parkinson’s patients now will be able to choose a less invasive treatment option.”

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment has less risk of surgical site infection (SSI) and is less invasive compared to existing invasive surgical procedures, as the treatment does not require skull perforation or implanted devices. There are 10 Exablate Neuro treatment centers in Japan currently treating essential tremor patients.

The Exablate Neuro device received approval by MHLW for the treatment of medication- refractory essential tremor in December 2016, and has National Health Insurance coverage since June 2019.

Parkinson’s disease (PD) is a progressive neurodegenerative disorder with a decrease of dopamine neuron cells in the substantia nigra. The number of PD patients in Japan is about 120,000, based on the survey by MHLW in 2013. Parkinson’s disease is classified as a designated intractable disease for additional financial support by the government.

Tremor, rigidity, slowness of movement and postural instability are the cardinal features of PD. When medication is not fully effective, stereotactic surgical treatments can be considered. Exablate Neuro is one of the surgical treatment options.

“Expanding the approved clinical indication to include Parkinson’s disease is a major milestone signaling adoption of focused ultrasound treatment in Japan.” said Yair Bauer, Country Manager, INSIGHTEC Japan.

“We are very pleased with what this news means – advancing treatments for more patients, through more applications for focused ultrasound in Japan,” commented Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. “Additional clinical applications contribute to the momentum around the world to move focused ultrasound toward a standard of care.”

 

About INSIGHTEC Japan K.K.

INSIGHTEC Japan K.K. is a subsidiary of INSIGHTEC LTD. The company is the regulatory market approval holder of Exablate Neuro (ExAblate 4000) and its distributor in Japan. Founded in 2005, its mission is to provide incisionless treatments for neurosurgery indications, in order to significantly improve the quality of life for patients in Japan.

 

About Insightec

Insightec® is a global medical technology innovator transforming patient lives through Incisionless Neurosurgery using MR-guided focused ultrasound. The company’s award-winning Exablate® Neuro is used by neurosurgeons 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 our website (http://www.insightec.co.jp), and Facebook page (www.facebook.com/INSIGHTEC.MRgFUS)

 

Media Contact

Yuichiro Koba – Marketing Manager, INSIGHTEC Japan K.K.
Email: jp_info@insightec.com Tel: 042-649-9761 Fax: 042-649-1015

 

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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