Microbot Medical, the developer of the Liberty robotic system, the first single-use endovascular robotic system, has received the histopathology report from the research laboratory that performed the animal study for the Liberty robotic system in October 2022. The company also reports that it has initiated preparations for potential first-in-human cases using the robotic system in Brazil.
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, 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 USA-based pivotal preclinical 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 US Food and Drug Administration (FDA).
Microbot Medical has also shared in a press release that it has initiated preparations for potential first-in-human cases in Brazil, by engaging with interventional radiologist Francisco Cesar Carnevale (University of São Paulo, São Paulo, Brazil). This collaboration is expected to support the company’s intention to conduct a FIH clinical trial in Brazil as part of its ongoing clinical and regulatory efforts.
“Following the successful usage of the LIBERTY system in over 100 preclinical catheterisation procedures, and the value the key opinion leaders that have performed those cases see in the Liberty system, the engagement with Prof Carnevale to perform the first clinical cases represents a major step as we aim to continue our efforts toward regulatory approvals and commercialisation,” commented Harel Gadot, chairman, CEO and president of Microbot Medical. “Parallel to working in our main target markets for our innovative robotic system, like the USA and Europe, we are constantly seeking additional collaboration and key opinion leaders, who wish to benefit their patients and the healthcare provider in their respective markets.”
The potential clinical cases are expected to commence upon completion of the verification and validation process of the Liberty robotic system, as well as obtaining the necessary regulatory approvals to perform those cases.