While over 5 million endovascular procedures are performed in the U.S. each year, Microbot says less than 1% are done robotically. | Source: Microbot Medical
Microbot Medical Inc. this week said it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for LIBERTY, a single-use, fully disposable robotic system for endovascular procedures. The company said it expects the FDA to clear LIBERTY during the second quarter of 2025.
“This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” stated Harel Gadot, the chairman, CEO, and president of Microbot Medical.
“We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S. each year,” he said. “We believe, based on feedback from physicians and the medical community, that Liberty is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system.”
Microbot Medical is a pre-commercial-stage medical technology provider. It said its vision is to improve the quality of care for millions of patients and providers globally. The Braintree, Mass.-based company said LIBERTY is the first step toward its goal of rethinking how robotics can benefit healthcare.
LIBERTY eliminates the need for large and expensive capital equipment and streamlines customers’ access to robotics, according to Microbot Medical. The company said it designed the system with a remote control to significantly reduce radiation exposure to physicians and staff, and improve ergonomics. This could reduce the physical strain on healthcare providers.
The surgical robot can be used in neurovascular, cardiovascular, and peripheral vascular procedures. The system includes a compact design and remote operating capabilities. Microbot also claimed that LIBERTY has the potential to lower procedure costs, increase procedure efficiency, and improve the overall quality of care.
The 510(k) submission follows Microbot’s multi-center, single-arm trial to evaluate the performance and safety of LIBERTY in human subjects undergoing peripheral vascular interventions.
In July, the company completed the first procedure in a clinical trial using its surgical robot. Investigators in the company’s pivotal human clinical trial completed the procedure at Brigham and Women’s Hospital (BWH) in Boston.
Recent highlights for the company include expanded U.S. operations ahead of the investigational device exemption (IDE) submission to prepare for the next steps. Microbot already had momentum after positive results from its good laboratory practices (GLP) pre-clinical study.
The company also secured a $2.154 million settlement of a lawsuit involving a securities purchase agreement in January.
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