Whereas over 5 million endovascular procedures are carried out within the U.S. annually, Microbot says lower than 1% are completed robotically. | Supply: Microbot Medical
Microbot Medical Inc. this week stated it has submitted a 510(ok) premarket notification to the U.S. Meals and Drug Administration for LIBERTY, a single-use, totally disposable robotic system for endovascular procedures. The corporate stated it expects the FDA to clear LIBERTY in the course of the second quarter of 2025.
“It is a pivotal milestone for our firm, because the 510(ok) submission displays the graduation of our transition to a commercially targeted firm,” acknowledged Harel Gadot, the chairman, CEO, and president of Microbot Medical.
“We’re excited to transition our focus in direction of making ready for our anticipated U.S. launch within the second quarter of 2025 and focusing on the greater than 2 million peripheral vascular procedures carried out within the U.S. annually,” he stated. “We imagine, primarily based on suggestions from physicians and the medical group, that Liberty is positioned to redefine the peripheral endovascular area with the introduction of the world’s first commercially out there single-use robotic system.”
Microbot Medical is a pre-commercial-stage medical expertise supplier. It stated its imaginative and prescient is to enhance the standard of take care of tens of millions of sufferers and suppliers globally. The Braintree, Mass.-based firm stated LIBERTY is step one towards its aim of rethinking how robotics can profit healthcare.
Extra concerning the LIBERTY system
LIBERTY eliminates the necessity for big and costly capital tools and streamlines prospects’ entry to robotics, in line with Microbot Medical. The corporate stated it designed the system with a distant management to considerably scale back radiation publicity to physicians and employees, and enhance ergonomics. This might scale back the bodily pressure on healthcare suppliers.
The surgical robotic can be utilized in neurovascular, cardiovascular, and peripheral vascular procedures. The system features a compact design and distant working capabilities. Microbot additionally claimed that LIBERTY has the potential to decrease process prices, enhance process effectivity, and enhance the general high quality of care.
The 510(ok) submission follows Microbot’s multi-center, single-arm trial to judge the efficiency and security of LIBERTY in human topics present process peripheral vascular interventions.
In July, the corporate accomplished the primary process in a medical trial utilizing its surgical robotic. Investigators within the firm’s pivotal human medical trial accomplished the process at Brigham and Girls’s Hospital (BWH) in Boston.
Current highlights for the corporate embrace expanded U.S. operations forward of the investigational machine exemption (IDE) submission to arrange for the subsequent steps. Microbot already had momentum after optimistic outcomes from its good laboratory practices (GLP) pre-clinical examine.
The firm additionally secured a $2.154 million settlement of a lawsuit involving a securities buy settlement in January.