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Devices Neurology FDA

 News Release - November 3, 2021

Insightec Announces FDA Approval of Exablate Neuro for the Treatment of Parkinson's Disease

The device is indicated for unilateral pallidotomy for medication-refractory patients with moderate to severe motor complications

MIAMI, Nov. 3, 2021 -- (Healthcare Sales & Marketing Network) -- Insightec®, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the U.S. Food and Drug Administration (FDA) has approved the Exablate® Neuro for treating advanced Parkinson's Disease patients suffering from mobility, rigidity, or dyskinesia symptoms.

The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus (GPi) during a pallidotomy. The treatment is incisionless, does not require brain implants, and has less risk of infection than invasive surgery.

"Movement disorder neurologists now can offer their Parkinson's patients a less invasive surgical option as part of their treatment plan," Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.

"This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson's disease," added Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.

Parkinson's disease (PD), a neurodegenerative disorder, affects an estimated one million patients in the United States. Tremor, rigidity, slow movement (bradykinesia), and postural instability are the cardinal features of PD. When medication induces side effects or is not well tolerated, surgical treatments, such as Focused Ultrasound, may be considered.

"This expanded approval of clinical indications to treat Parkinson's Disease signifies the growing understanding and acceptance of Focused Ultrasound as an effective treatment modality," commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors. "More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions."

The Exablate Neuro device received approval by the FDA for the treatment of medication-refractory Essential Tremor in 2016 and for Tremor-dominant Parkinson's Disease in 2018. There are currently 37 medical centers in the United States using the Insightec Exablate Neuro device to treat patients with medication-refractory Essential Tremor and Tremor-dominant Parkinson's Disease.

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. 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.

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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.


Source: Insightec

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