Insightec has received the US Food and Drug Administration (FDA) approval for the use of its Exablate Neuro platform for staged bilateral focused ultrasound treatment in patients with advanced Parkinson’s disease (PD).
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.
The expanded approval enables complete bilateral treatment, providing a new therapeutic option for people with severe motor symptoms such as rigidity, bradykinesia, and dyskinesia.
Exablate Neuro platform employs focused ultrasound to precisely target areas in the pallidothalamic tract, guided by MRI.
The procedure is non-invasive, does not require implanted hardware, and presents a lower risk profile compared to traditional surgical methods.
The new indication covers both the initial and subsequent staged procedures.
Insightec CEO and chairman Maurice Ferré said: “This milestone reflects our commitment to expanding access to safe, effective, and incisionless treatment options for people living with Parkinson’s disease.
“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 platform focuses sound waves that are safely guided by MRI to deliver treatment to patients with medication-refractory essential tremor and PD.
The FDA approval was supported by positive outcomes from a clinical trial conducted across nine centres in Asia, Europe, and the US. Full results from the study are anticipated later this year.
To date, over 25,000 patients have been treated with Exablate technology for various movement disorders at 197 centres worldwide, including 84 in the US.
Insightec plans a limited launch of the bilateral procedure in select centres during 2025, alongside efforts to establish reimbursement pathways for broader patient access.
Weill Cornell Medicine-New York Presbyterian Hospital department of neurological surgery Dr. Michael Kaplitt said: “This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson’s disease.
“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.”
Palm Beach Health Network comprehensive movement disorders center director Arif Dalvi said: “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 anaesthesia, offers new hope for persons with Parkinson’s disease.”
