MR-guided ultrasound developer Insightec has received investigational device exemptions from the U.S. Food and Drug Administration (FDA) for new applications of its Exablate Neuro system in clinical trials.
One study will evaluate the use of Exablate Neuro to treat patients with primary non-small cell lung cancer that has metastasized to the brain in conjunction with Keytruda, a humanized antibody immunotherapy. Exablate Neuro could be used to open up the blood-brain barrier to make immunotherapy agents like Keytruda more effective.
The other study will explore the use of Exablate Neuro in conjunction with liquid biopsy for recurrence monitoring of patients with primary brain cancer. Liquid biopsy is a new approach for noninvasive cancer subtyping, treatment selection, monitoring residual disease, and early identification of treatment responders versus nonresponders.
Exablate Neuro uses low-intensity focused ultrasound to increase the permeability of the blood-brain barrier and allow passage of region-specific biomarkers to enable noninvasive liquid biopsy in brain tumors.
The device received FDA approval for use in treating medication-refractory essential tremor in 2016, and in 2018 for tremor-dominant Parkinson's disease.
