FDA Clears Microbot Medical's Remote-Controlled Catheter System, Marking Milestone in Endovascular Robotics

Microbot Medical has achieved a significant breakthrough in endovascular robotics with the FDA's 510(k) clearance of its Liberty system, a remote-controlled robot designed for minimally invasive procedures. This innovative technology promises to revolutionize catheter-based interventions by allowing clinicians to operate outside the radiation field of the catheterization laboratory.

Liberty System: A Game-Changer in Endovascular Procedures

The Liberty system features a disposable, palm-sized driver that advances catheters and guidewires during procedures. Connected to a videogame-like controller, the system boasts near-universal compatibility with existing interventional hardware. This versatility positions Liberty to address an estimated 2.5 million annual peripheral endovascular procedures in the United States alone.

Harel Gadot, President and CEO of Microbot Medical, emphasized the significance of this achievement: "Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare."

Promising Clinical Results and Safety Profile

In April, Microbot Medical announced pivotal study data that demonstrated the Liberty system's efficacy and safety. The single-arm trial, involving 20 patients, reported:

• 100% successful robotic navigation in all cases
• No need to switch to manual manipulation of catheters and guidewires
• Absence of serious complications in the three days post-procedure
• 92% reduction in operator radiation exposure
• Median navigation time of three minutes

These results, presented at the annual meeting of the Society of Interventional Radiology in Nashville, underscore the system's potential to improve both patient outcomes and operator safety.

Commercial Outlook and Market Positioning

With FDA clearance secured, Microbot Medical is poised to accelerate its market entry. Gadot noted, "With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well-positioned to accelerate market entry."

The company's focus on the U.S. market, with its substantial addressable procedure volume, suggests a strategic approach to commercialization. As Microbot Medical looks to expand globally, the Liberty system could significantly impact the landscape of endovascular robotics and minimally invasive interventions worldwide.