Microbot Medical Inc. has received the histopathology report from the European-based MedTech research laboratory that performed the animal study for the LIBERTY Robotic System in October 2022.
During the animal study, the physicians conducted 63 navigations to the targeted sites using the investigational LIBERTY Robotic System and performed an equal number of procedures manually. The LIBERTY Robotic System received overwhelmingly positive feedback from participating physicians, and there were no observable immediate intraoperative adverse events, or harm, to the test subjects.
The new data from the report, which included histopathology data (the microscopic examination of tissue to study the manifestations of disease), exhibited equivocal results which were identified as related to unusual physiological animal responses in both manual and robotic test groups.
The Company believes the results of the study allow it to move forward and focus on the next phases to ultimately include a U.S.-based pivotal pre-clinical study.
The Company, together with its regulatory experts and consultants, believe a larger sample size and robust data generated by this study will advance the company’s efforts towards the submission of Investigational Device Exemption (IDE) with U.S. Food and Drug Administration (FDA).
Source: Microbot Medical