Prospective, multicenter study is the first to systematically evaluate staged, bilateral MRgFUS in Parkinson’s disease, showing 66.8% improvement in motor complications and substantial reduction in the proportion of patients experiencing dyskinesia at three months

MIAMI and HAIFA, Israel, June 18, 2026 /PRNewswire/ — Insightec, a global healthcare company dedicated to using MR-guided focused ultrasound (MRgFUS) to transform patient care, today announced the publication of pivotal Parkinson’s disease (PD) clinical trial results in The Lancet Neurology. Using Insightec’s Exablate® Neuro system, this prospective, multicenter study evaluated staged bilateral MRgFUS treatment for Parkinson’s disease and demonstrates that the incisionless procedure produces substantial and durable improvements in disabling motor symptoms, with benefits appearing within one month and sustained through 12 months.  

In this study, patient-reported time spent experiencing dyskinesia, the uncontrolled, involuntary movements that can severely affect quality of life, fell from approximately 75% of waking hours at baseline to just 14% following the second-side procedure. Overall motor complications improved by 66.8% three months after bilateral treatment, with benefits sustained through follow-up at 12 months.

“For people living with Parkinson’s disease, the impact on daily life can be devastating and surgical options have been limited for far too long,” said Arif Dalvi, MD, Director, Comprehensive Movement Disorders Center, Palm Beach Health Network, and top-enrolling investigator of the study. “This study gives us the evidence-based guidance we’ve been waiting for, demonstrating that focused ultrasound treatment can deliver meaningful, lasting relief for Parkinson’s that builds with each procedure. Importantly, it expands the role of this treatment beyond tremor, to address the motor fluctuations and involuntary movements that make daily life so difficult in later-stage Parkinson’s.”

The prospective, multicenter trial enrolled 54 patients at nine investigational centers (six in the U.S., two in Spain and one in Taiwan) and treated between July 2021 and November 2023. Patients underwent a unilateral MRgFUS procedure followed by a second-side procedure at least six months later, using Insightec’s Exablate Neuro system. The staged bilateral approach, treating one side of the brain first and the other at a later date, allowed researchers to systematically evaluate both the incremental and cumulative effects of bilateral treatment. Improvements in symptoms were seen within one month of treatment and maintained through the duration of the study (over 2 years from first side treatment). Most adverse events were mild to moderate; speech and gait effects were more frequent following second-side treatment, highlighting the importance of patient selection.

Key study findings:

• Motor complications improved by 66.8% at three months after bilateral treatment, with benefits sustained through follow-up.
• Primary motor endpoint improved 32.6% at 3 months after second-side treatment.
• Patient-reported time with dyskinesia fell from roughly 75% at baseline to 14% after second-side treatment.
• Mild to severe time spent in the OFF state, which refers to periods when a patient’s medications are not working optimally, fell roughly 50%.

“This study is the next chapter in our commitment to expanding access to safe, effective, and incisionless treatment for people living with Parkinson’s disease,” said Maurice R. Ferré, MD, CEO and Chairman of Insightec. “MR-guided focused ultrasound has already changed the lives of thousands of patients, and peer-reviewed evidence like this brings us closer to making it available to the many more who need it now and in the years ahead.”

Insightec’s Exablate Neuro platform received U.S. Food and Drug Administration approval in July 2025 for staged bilateral pallidothalamic tractotomy treatment in patients with advanced symptoms of PD, expanding access to care for the estimated 1.2 million Americans living with the disease by 2030.

To date, more than 30,000 patients have been treated with Insightec’s Exablate technology for a variety of movement disorder indications at 214 centers worldwide, including 104 in the U.S.

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

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, Texas; Frankfurt, Germany; Shanghai; and Tokyo.

Follow us on LinkedIn, Facebook, Instagram, YouTube and X or visit insightec.com for more information. *For detailed country specific indications visit https://insightec.com/regulatory-approvals/.

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.

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SOURCE Insightec