Microbot Begins Site Selection for Liberty Robotic System Pivotal Trial

June 20, 2024—Microbot Medical Inc. announced an agreement with Brigham and Women’s Hospital (BWH) in Boston, Massachusetts, for BWH to serve as an investigational site for the company’s pivotal trial of the Liberty endovascular robotic surgical system.

Microbot completed a site initiation visit to train the BWH clinical staff in the study protocols and delivered a shipment of Liberty investigational units to BWH, noted the press release.

Dmitry Rabkin, MD, will lead the study for the site as Principal Investigator at BWH. Dr. Rabkin is Assistant Chief of the Division of Angiography & Interventional Radiology at BWH.

“We are excited to participate in the clinical evaluation of this innovative technology,” commented Dr. Rabkin in Microbot’s press release.

Harel Gadot, CEO, President, and Chairman of Microbot Medical, stated, “We are pleased to work with Dr. Rabkin and the team at BWH on this clinical study. We believe their commitment to research and the advancement of science makes them an ideal clinical study site.”

Earlier this month, the company announced it received FDA approval to proceed with the pivotal clinical trial as part of its investigational device exemption (IDE) application for the Liberty system. The study will be conducted in the United States to support a future 510(k) submission.

The company advised that in addition to this first clinical trial service agreement with BWH, it is in the process of engaging other leading centers to participate in the trial. In parallel to commencing the pivotal clinical trial, Microbot is completing its biocompatibility tests as required by its IDE application.

According to the company, the remote operation of its investigational Liberty endovascular robotic surgical system is intended to eliminate the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain.

In December 2023, Microbot announced the completion of its GLP pivotal preclinical study of the Liberty system, which used a porcine model to perform 96 robotic navigations. The study was conducted by three leading interventional radiologists under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting.