Microbot Medical announces completion of GLP pre-clinical study

Microbot Medical announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model. The study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations. 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 Endovascular Robotic Surgical System. “Today’s announcement marks another important milestone for the Company, as we continue our transition from R&D and pre-clinical phase into the clinical, regulatory and pre-commercial phase,” commented Harel Gadot, CEO. “We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical study, completing our transition to a clinically stage company.”