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Insightec Announces FDA Approval of Staged Bilateral Focused Ultrasound Treatment for Parkinson's Disease

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News provided by

INSIGHTEC

Jul 08, 2025, 08:45 ET

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Expanded indication of incisionless Exablate Neuro platform offers new hope for 50,000+ patients

HAIFA, Israel and MIAMI, July 8, 2025 /CNW/ -- Insightec, a global healthcare innovator dedicated to using focused ultrasound to transform patient care, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease (PD).

This new indication covers both the initial and the subsequent staged procedure, enabling comprehensive bilateral treatment. This provides an expanded therapeutic option for patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia due to PD who haven't found relief from medication.

"This milestone reflects our commitment to expanding access to safe, effective, and incisionless treatment options for people living with Parkinson's disease," said Maurice R. Ferré, MD, CEO and Chairman of Insightec. "With this new indication, we're advancing care for movement disorders and opening the door to life-changing treatment for those who need it now and in the years ahead."

Exablate Neuro uses focused ultrasound to precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The procedure is incisionless, does not require implanted hardware, and offers a lower risk profile compared to traditional surgical interventions.

"This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson's disease," said Dr. Michael Kaplitt, Department of Neurological Surgery, Weill Cornell Medicine-New York Presbyterian Hospital.  "As the lead investigator of the clinical trial evaluating the safety and effectiveness of the staged bilateral procedure with the Exablate system, I'm encouraged by the results and am excited about what it offers my patients."  

The clinical trial, conducted at nine centers across the U.S., Europe and Asia, demonstrated encouraging outcomes that played a key role in supporting FDA approval. Full results from the study are expected to be published later this year.

PD is expected to affect more than 1.2M Americans by 2030. While medications remain the first line of treatment, many patients eventually experience side effects or diminishing efficacy, prompting the need for additional treatment options. Insightec plans a limited launch of the bilateral procedure in select centers during 2025, along with ongoing efforts to establish routine reimbursement pathways to ensure broader patient access.

"The ability of MR-guided focused ultrasound to precisely target both sides of the brain and improve disabling symptoms, without the need for a surgical incision or anesthesia, offers new hope for persons with Parkinson's disease," said Dr. Arif Dalvi, Director, Comprehensive Movement Disorders Center, Palm Beach Health Network and top-enrolling investigator.

The Exablate Neuro platform previously received FDA approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant PD in 2018, unilateral pallidotomy for Parkinson's-related dyskinesia and motor symptoms in 2021 and staged unilateral treatment for ET patients on for the contralateral (second) side.

To date, more than 25,000 patients have been treated with Insightec's Exablate technology for a variety of movement disorder indications at 197 centers worldwide, including 84 in the U.S.

For full safety information on the treatment please visit https://insightec.com/safety-information/.  

In addition to receiving research support, Drs. Kaplitt and Dalvi are or have been paid Insightec consultants.

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 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, with offices in Dallas, Shanghai, and Tokyo.

*For detailed country specific indications visit https://insightec.com/regulatory-approvals/ 

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.

Logo - https://mma.prnewswire.com/media/2726209/Insightec_Logo.jpg

SOURCE INSIGHTEC

Insightec Media Contact: G&S Business Communications for Insightec, Marjani Williams, [email protected], (312) 648-6700, ext.2108

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INSIGHTEC

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