FDA approves pivotal trial for Insightec’s Exablate Neuro in Parkinson’s

Insightec said today that it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease.

Haifa, Israel-based Insightec said the the study will evaluate using Exablate Neuro’s MR-guided focused ultrasound to ablate portions of the globus pallidus in the brain, which helps regulate voluntary movement. The trial, led by principal investigator Dr. Howard Eisenberg of the University of Maryland, aims to treat dyskinesia in patients with advanced Parkinson’s who have not responded to medication.

“Insightec remains committed to advancing research to expand indications for our incision-less focused ultrasound technology to improve patient lives,” chairman & CEO Dr. Maurice R. Ferré, who led Mako Surgical until its $1.7 billion acquisition by Stryker (NYSE:SYK), said in prepared remarks.

The pivotal study, estimated to enroll 116 patients, is slated to start in January 2018 with final data for the primary outcome due by the end of 2019, according to ClinicalTrials.gov. The primary outcome is change in the Unified Dyskinesia Rating Scale at three months, with a secondary endpoint of severity of peri-operative device- and procedure-related complications.

The company won pre-market approval from the FDA for Exablate Neuro in June 2016 for treating essential tremor in patients who don’t respond to drug therapy. Insightec applied for pre-market approval for the Exablate Neuro treatment in October 2015.