Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro study

Insightec today touted results from a pivotal study of its Exablate Neuro system, which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor score at 3 months.

Data from the study were published today in the New England Journal of Medicine.

“MRI imaging and thermometry provide a high level of control during focused ultrasound thalamotomy. Importantly, before treatment, adjustments can be made based on intraoperative imaging and clinical feedback from the patient, contributing to a safe procedure,” primary study author Dr. W. Elias of the University of Virginia said in a press release.

The 76-patient study looked to evaluate the safety and efficacy of the device to treat essential tremor in patients who were unresponsive to medication, and data from the study was submitted to the FDA as the company seeks approval. If won, the approval would the the 1st for a focused ultrasound device designed to treat essential tremor.

“The robust study findings showed that focused ultrasound safely improved hand tremor in patients with refractory tremor by precisely targeting and ablating deep brain tissue without surgical incisions, thus minimizing risk of infection, bleeding or other complications sometimes seen in surgical operations,” tremor research group prez Dr. William Ondo said in a prepared statement.

Patients in the Exablate Neuro cohort reported a reduction of nearly 50% on the Clinical Rating Scale for Tremor parts A and B at 3 months, moving from an initial mean score of 18.1±4.8 which was reduced to 9.6±5.1 at 3 months. Patients in the sham cohort of the trial showed no change in ratings, Insightec reported.

“We are pleased with the results of this pivotal study that addresses a major issue for the five million Americans and millions more worldwide that suffer from this debilitating disease. With this positive data and the subsequent FDA approval of the Exablate Neuro system, patients can be treated and return to performing everyday tasks with greater ease and enjoy a better quality of life,” CEO Dr. Maurice Ferré said in a prepared statement.

Exablate Neuro patients in the trial reported a 63.4% reduction in tremor amplitude which maintained up to a 1-year follow up, while total disability scores were improved by 68% on average. Quality of life assessments showed a 51% improvement overall at 12 months for treated patients.

The majority of adverse events were transient, minimal or unrelated to the Exablate Neuro procedure, Insightec said. Funding for the study was provided by the Focused Ultrasound Foundation, US-Israel Binational Industry R&D and INSIGHTEC.

Earlier this month, Insightec said it inked a collaborative strategic deal with Siemens Healthineers (NYSE:SI) to develop compatibility between Insightec’s Exablate Neuro system and Siemens Magnetom Aera and Skyra 1.5 Tesla and 3T clinical MRI systems.

The companies said the agreement will expand Siemens diagnostic imaging portfolio and will allow existing and future Siemens MRI customers access to the Exablate Neuro system.

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