- Microbot Medical (MBOT, Financial) achieves a 100% success rate in the pivotal trial of its LIBERTY® Endovascular Robotic System.
- The trial shows a substantial 92% reduction in radiation exposure to operators.
- LIBERTY® system pending FDA 510(k) clearance, with no adverse device events reported.
Microbot Medical Inc. (MBOT), a leader in medical robotics, has announced promising results from its pivotal ACCESS-PVI trial for the LIBERTY® Endovascular Robotic System. Conducted at three premier U.S. medical centers, the study achieved a 100% success rate in robotic navigation for all cases (N=20), fully meeting the primary endpoint.
The trial recorded notable achievements, including a 92% reduction in radiation exposure for operators and no adverse device events throughout the course. The median robotic navigation time was an efficient 3 minutes, and the system earned a 100% physician satisfaction rate, underscoring its potential for clinical adoption.
Conducted at Memorial Sloan Kettering Cancer Center in New York, Baptist Hospital of Miami in Florida, and Brigham and Women's Hospital in Massachusetts, the trial underscores the system's safety and efficacy. However, the LIBERTY® system is still pending FDA 510(k) clearance and is not yet available for sale in the U.S.
Microbot Medical plans to shift focus from research and development to building commercial capabilities in preparation for a successful market launch once regulatory clearance is obtained. This transition is crucial for the company's strategy to leverage its technological advancements in the competitive interventional robotics landscape.