Microbot Medical’s Liberty Robot Study Draws to a Close

Microbot Medical Inc. has successfully completed enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial, which examined the performance of the company’s LIBERTY Endovascular Robotic Surgical System.

Consequently, Microbot Medical remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of the year.

“We are very pleased with the performance of LIBERTY throughout the study,” Microbot Medical Chief Medical Officer Juan Diaz-Cartelle, M.D., said. “We want to thank all our investigators for their commitment to the trial. We expect to share the results of the clinical trial with the medical community and the public at a conference in early 2025.”

The company is now accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including hiring a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance (expected during Q2 2025).

“This is a monumental moment and a significant achievement for Microbot Medical,” Chairman/CEO/President Harel Gadot stated. “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.

ACCESS-PVI is a prospective, multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY Endovascular Robotic Surgical System in patients undergoing peripheral vascular interventions. The trial will support the FDA 510(k) submission and subsequent commercialization.

Microbot Medical Inc. is a clinical-stage medical device company specializing in transformational micro-robotic technologies, attempting to improve clinical outcomes for patients and increase accessibility through the body’s natural and artificial lumens.

The Investigational LIBERTY Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company claims LIBERTY’s remote operation can potentially be the first system to democratize endovascular interventional procedures.