Microbot Medical Announces FDA Submission For The Commercialization Of The LIBERTY Endovascular Robotic System; FDA 510(k) Clearance Anticipated During Q2 2025

FDA 510(k) Submission Follows the Successful Completion of the Pivotal Human Clinical Trial

FDA 510(k) Clearance Anticipated During the Second Quarter of 2025

Company Preparing to Commence Commercialization Following FDA 510(k) Clearance

BRAINTREE, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative single use LIBERTY® Endovascular Robotic System, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for LIBERTY®. LIBERTY® is the world's first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of its multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions.

The Company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.