Microbot Medical LIBERTY System Trial Advancing Faster Than Expected

Enrollment in Microbot Medical Inc.’s ACCESS-PVI human clinical trial for the LIBERTY Endovascular Robotic Surgical System is progressing faster than expected, and will likely be completed ahead of schedule.

According to the company, 80% of the study subjects have completed the follow up period, enabling Microbot Medical to file a 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of the year.
 
“The trial is progressing well, and I am pleased with the level of enthusiasm at all three clinical sites which has resulted in the acceleration of patient enrollment. This gives us additional confidence that we can complete the trial and submit for FDA clearance by the end of 2024,” Microbot Medical Chairman/CEO/President Harel Gadot said.

ACCESS-PVI is a prospective, multi-center, single-arm trial to evaluate the LIBERTY’s performance and safety in patients undergoing peripheral vascular interventions. The trial supports an FDA submission and subsequent commercialization.
 
Microbot Medical has successfully completed all biocompatibility tests as required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. In conjunction with the clinical trial, the company is performing additional customary bench testing, and the final results will be included in the FDA 510(k) submission.

“I applaud the entire team at Microbot Medical and the physicians participating in the study as we near the finish line. I believe their continued commitment will allow us to maintain the positive momentum over the next several weeks and allow us to achieve our near-term milestones, including the completion of the study,” Microbot Medical Chief Medical Officer Juan Diaz-Cartelle, M.D., stated.
 
Microbot Medical Inc. is a clinical- stage medical device company that specializes in transformational micro-robotic technologies to improve clinical outcomes for patients and increasing accessibility through the human 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 believes the LIBERTY System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.