Microbot Medical Inc. (NASDAQ: MBOT) has announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its LIBERTY Endovascular Robotic System. This marks a significant milestone for the company as it transitions towards commercialization. The company anticipates potential FDA clearance during the second quarter of 2025, paving the way for a U.S. commercial launch shortly thereafter.
The LIBERTY system is designed as a single-use, fully disposable robotic system intended for endovascular procedures. A key feature of the system is its potential to reduce radiation exposure to physicians and staff through remote control operation, while also improving ergonomics and reducing physical strain on healthcare providers.
ACCESS-PVI Trial Results
The 510(k) submission is supported by the successful completion of the ACCESS-PVI pivotal human clinical trial. This multi-center, single-arm trial evaluated the performance and safety of the LIBERTY system in patients undergoing peripheral vascular interventions. The trial was conducted across three leading medical centers in the U.S.: Miami Baptist (Miami, FL), Memorial Sloan Kettering (NYC, NY), and Brigham & Women’s (Boston, MA).
Francois Cornelis, MD, PhD, FCIRSE, from Memorial Sloan Kettering Cancer Center, will present the ACCESS-PVI trial data at the Society of Interventional Radiology (SIR) annual meeting on April 2, 2025, in Nashville, TN. The presentation, titled "Remote-controlled endovascular navigation with a miniature, single-use, robotic system. Results of the ACCESS-PVI trial," will highlight the potential benefits of the LIBERTY system to the interventional radiology community.
Strategic Initiatives and Collaborations
Microbot Medical has also focused on establishing pre-commercial infrastructures and executing strategic initiatives to support future growth. This includes receiving ISO 13485 certification for its quality management system, initiating inventory build-up, and completing Phase 1 and Phase 2 of a telesurgery collaboration with Corewell Health. Furthermore, the company has entered into an agreement with Emory University to collaborate on the development of autonomous robotics.
Market Opportunity
With over 2 million peripheral vascular procedures performed annually in the U.S., Microbot Medical believes that LIBERTY is positioned to redefine the peripheral endovascular space by offering the world’s first commercially available single-use robotic system. The company aims to eliminate traditional barriers to accessing advanced robotic systems, potentially lowering procedure costs, increasing efficiency, and improving the overall quality of care.
