Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system.
The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs.
In this study, three interventional radiologists performed 96 robotic navigations using Liberty. They used the system to control various commercially available intravascular catheterization devices. They then microscopically examined and evaluated the target vessels and surrounding tissue.
Microbot Medical officials think Liberty’s remote operation could enable it to democratize endovascular interventional procedures.
“I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, chief medical officer of Braintree, Massachusetts–based Microbot Medical. “This gives us confidence to move forward to the next stage of human clinical study.”
Microbot Medical CEO Harel Gadot added in the news release that the milestone marks another step in the company’s transition from R&D and pre-clinical phases to clinical, regulatory, and pre-commercial stages. “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.”