The results from the GLP pre-clinical study, which was conducted as per the US Food and Drug Administration (FDA) guidelines for planning, controlling, monitoring, and reporting, will support IDE submission to the FDA to commence a human clinical study
LIBERTY is a disposable advanced surgical robot. (Credit: Piron Guillaume on Unsplash)
US-based medical device company Microbot Medical has announced positive results for its LIBERTY endovascular robotic surgical system from GLP pre-clinical study.
The study was conducted as per the US Food and Drug Administration (FDA) guidelines for planning, controlling, monitoring, and reporting, using a porcine model.
Its results will support IDE submission to the FDA to commence a human clinical study.
Last month, Microbot announced that three interventional radiologists conducted the study using the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 procedures.
In the study, target vessels with surrounding tissue were examined and evaluated microscopically after they were subjected to procedures using a range of commercially available intravascular catheterisation devices controlled and manipulated through the LIBERTY system.
Microbot Medical chief medical officer Juan Diaz Cartelle said: “I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study. This gives us confidence to move forward to the next stage of human clinical studies.”
Microbot Medical CEO Harel Gadot said: “Today’s announcement marks another important milestone for the company, as we continue our transition from the R&D and pre-clinical phase into the clinical, regulatory and pre-commercial phase.
“We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical trial, completing our transition to a clinically stage company.”
Microbot Medical is a pre-clinical medical device company specialising in micro-robotic technologies to improve clinical outcomes for patients.
Its LIBERTY endovascular robotic surgical system is a fully disposable advanced surgical robot with remote operation capabilities to streamline endovascular procedures.
Designed based on feedback from the hands-on experience of physicians, the surgical system aims to improve the way surgical robotics are being used in endovascular procedures.
The system eliminates the need for large, cumbersome and expensive capital equipment.
In 2022, Microbot secured a design patent allowance from the US Patent and Trademark Office (USPTO), covering the interface design of a remote controller for its LIBERTY Robotic System.