Insightec’s Exablate Neuro System Designated an FDA Breakthrough Device

Insightec’s Exablate Neuro system has been designated a Breakthrough Device by the FDA for treatment of primary nonsmall-cell lung cancer (NSCLC) that has metastasized to the brain in conjunction with the standard of care, Merck’s Keytruda (pembrolizumab).

The device uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants.

It has also received FDA approval to be studied in a pivotal clinical trial for NSCLC and in a separate trial for enhanced efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer.

The NSCLC study will assess the clinical benefit of using noninvasive, low-intensity focused ultrasound combined with systemic immunotherapy in the treatment of patients with brain metastases from lung cancer, the company said.

The Exablate Neuro system is already FDA-approved for the treatment of medication-refractory essential tremor and Parkinson's Disease.