Microbot Medical Receives FDA Clearance for Endovascular Robotic System, Poised to Enter U.S. Market

Microbot Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Liberty Endovascular Robotic System, marking a significant milestone in the field of robotic-assisted peripheral vascular procedures. The clearance positions the company to begin marketing its innovative single-use, remotely operated robotic system in the United States.

Liberty System: Advancing Endovascular Procedures

The Liberty Endovascular Robotic System features a video game-style controller that allows physicians to remotely guide instruments through blood vessels. This design aims to reduce radiation exposure and physical strain on medical professionals during procedures. Microbot has focused on improving maneuverability, simplifying setup and operation, and eliminating the need for expensive surgical tool exchanges.

In a recent study conducted at three U.S. medical centers, the Liberty system demonstrated promising results. The trial reported a 92% relative reduction in radiation exposure for operators, a 100% success rate in robotic navigation to target areas, and zero device-related adverse events. These findings underscore the potential benefits of the system in enhancing both patient and physician safety.

Commercialization and Market Potential

With FDA clearance secured, Microbot Medical is now set to complete final commercial activities in preparation for market entry. CEO Harel Gadot expressed optimism about the company's future, stating, "We are positioned to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures and pursue entry into global markets."

The company's financial position appears stable, with $4.1 million in cash and cash equivalents reported at the end of June. Additionally, Microbot recently secured a grant of approximately $630,000, which it plans to use to strengthen its manufacturing capabilities to support the commercialization of Liberty in the U.S.

Competitive Landscape in Robotic Endovascular Systems

Microbot Medical's entry into the U.S. market comes at a time of flux in the robotic endovascular space. Siemens Healthineers, which acquired Corindus Vascular Robotics for $1.1 billion in 2019, recently exited the robotic-assisted endovascular cardiology business to focus on neurovascular interventions. This shift may create opportunities for new players like Microbot Medical.

In Europe, competitor Robocath launched its R-One+ robotic platform in 2023, though it has yet to receive authorization in the U.S. As Microbot prepares to target the substantial U.S. market for peripheral vascular procedures, the company's innovative approach and recent FDA clearance position it as a potential leader in this evolving field of medical robotics.