Insightec announced that the U.S. Food and Drug Administration has approved the use of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease. This expanded indication covers both the initial and subsequent staged procedures, enabling comprehensive bilateral treatment for patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia who haven't found relief from medication.
The approval represents a significant advancement for the estimated 50,000+ patients who could benefit from this treatment option. Parkinson's disease is expected to affect more than 1.2 million Americans by 2030, and while medications remain the first line of treatment, many patients eventually experience side effects or diminishing efficacy.
Technology and Treatment Approach
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. The technology focuses sound waves safely guided by MRI to provide treatment without the need for surgical incision or anesthesia.
"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."
Clinical Evidence and Expert Perspectives
The clinical trial supporting this approval was conducted at nine centers across the U.S., Europe and Asia, demonstrating encouraging outcomes that played a key role in supporting FDA approval. Full results from the study are expected to be published later this year.
"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, who served as the lead investigator of the clinical trial evaluating the safety and effectiveness of the staged bilateral procedure.
Dr. Arif Dalvi, Director of the Comprehensive Movement Disorders Center at Palm Beach Health Network and top-enrolling investigator, emphasized the clinical significance: "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."
Treatment History and Future Plans
The Exablate Neuro platform has a progressive history of FDA approvals, having previously received approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant Parkinson's disease in 2018, unilateral pallidotomy for Parkinson's-related dyskinesia and motor symptoms in 2021, and staged unilateral treatment for essential tremor patients on the contralateral side.
To date, more than 25,000 patients have been treated with Insightec's Exablate technology for various movement disorder indications at 197 centers worldwide, including 84 in the U.S.
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 company, founded in Israel in 1999 and led from Miami since 2016, has secured more than $800 million in equity and debt financing since its founding, including a $150 million equity round led by Fidelity Management in 2024.
