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December 28, 2023
Microbot’s Liberty Robotic System Meets Objectives in Pivotal Preclinical Study
December 28, 2023—Microbot Medical Inc., a preclinical medical device company specializing in microrobotic technologies, announced the completion of its GLP pivotal preclinical study of the Liberty endovascular robotic surgical system.
The GLP study used a porcine model to perform 96 robotic navigations using the Liberty device. The study was conducted by three leading interventional radiologists under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, noted the company.
According to Microbot, target vessels with surrounding tissue were examined and evaluated microscopically after they were subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via the Liberty system.
“I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” commented Juan Diaz Cartelle, MD, Chief Medical Officer of Microbot, in the company’s press release. “This gives us confidence to move forward to the next stage of human clinical studies.”
Microbot’s CEO Harel Gadot added, “Today’s announcement marks another important milestone for the company, as we continue our transition from R&D and preclinical phase into the clinical, regulatory, and precommercial phase. We expect to submit our investigational device exemption application to the FDA soon and commence our pivotal human clinical trial, completing our transition to a clinically stage company.”
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