The Braintree, Massachusetts–based company completed enrollment and follow-up for all patients in the ACCESS-PVI human clinical trial. It now expects to file an FDA 510(k) submission for the Liberty endovascular surgical robot system by the end of 2024.
Additionally, Microbot announced plans to accelerate its go-to-market strategy in advance of its regulatory submission. It expects to begin building out commercial infrastructure, which includes hiring a seasoned healthcare executive to lead sales efforts. The company earmarked this for when it earns FDA clearance, which it anticipates in the second quarter of 2025.
Microbot designed its Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians. Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.
“This is a monumental moment and a significant achievement for Microbot Medical,” said Harel Gadot, chair, CEO and president. The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalize the FDA 510(k) submission package so we can file it by the end of the year. Concurrently, we will deploy our go-to-market strategy and begin to build out a commercial infrastructure to ensure we are fully prepared to launch Liberty upon the FDA’s clearance, which we expect during 2Q 2025.”
