Microbot’s Liberty Robotic System to Be Studied in FDA-Approved IDE Pivotal Trial

June 11, 2024—Microbot Medical Inc. recently announced it received FDA approval to proceed with the pivotal clinical trial as part of its investigational device exemption (IDE) application for its Liberty endovascular robotic surgical system. The study will be conducted in the United States to support a future 510(k) submission.

The company advised that it has signed a clinical trial service agreement with a leading academic medical center. Additionally, it is in the process of engaging additional leading centers to participate in the trial.

In parallel to commencing the pivotal human clinical trial, Microbot is completing its biocompatibility tests as required by its IDE application.

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

According to Microbot, the investigational Liberty system aims to improve the way surgical robotics are used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment while reducing radiation exposure and physician strain.

“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive preclinical studies and tests, reinforces our confidence in our innovative technology,” commented Harel Gadot, Microbot’s CEO, President, and Chairman, in the press release. “It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the United States and other regions across the globe.”