Elbit Says FDA Approves INSIGHTEC's Exablate Neuro for Essential Tremor Treatment

Elbit Imaging Ltd. EMITF revealed that today that it was informed by INSIGHTEC Ltd. that the FDA has given its approval for its Exablate Neuro system for a non-invasive treatment of essential tremor (ET) in patients, who have not responded to medication. Elbit Imaging said that Exablate Neuro utilized concentrated ultrasound waves to exactly target and ablate tissue deep within the brain with no incisions or implants. The company added that the treatment was done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The company indicated that essential tremor was the most common movement disorder, and affects over 5 million people in the United States alone apart millions around the world. The company added that hand tremor was the most common symptom. However, tremors could affect the head, arms, voice, legs, and torso. Elibit statement said, "This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRI-guided Focused Ultrasound. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy." Following this, the stock traded 5.12 percent up on Tuesday.