With its remote endovascular procedure system currently under review at the FDA, Microbot Medical has put forward positive results from a pivotal study touting a 100% satisfaction rate among physicians.
Microbot’s miniaturized, disposable Liberty system is designed to advance and control off-the-shelf guidewires and catheters as they move through the body during minimally invasive procedures while the interventionalist operates the device at a safe distance, seated outside the radiation imaging field.
The company’s single-arm clinical trial involved 20 patients undergoing peripheral vascular procedures and demonstrated successful robotic navigation in every case—with all clinicians reaching their targets without needing to switch to manual manipulation, meeting the study’s primary endpoint.
Microbot said that no adverse events related to the device were reported within the three days following the procedure.
The study also measured a 92% reduction in operator radiation exposures, by an average of 29.8 microsieverts, while the median navigation time was 3 minutes. The results were presented as a late-breaking abstract at the annual meeting of the Society of Interventional Radiology in Nashville.
“We are extremely pleased with the results in all aspects,” Microbot President and CEO Harel Gadot said in a statement. “As we shift focus to building our commercial capabilities and preparing for launch, we are confident that Liberty will be well received in the market.”
The company has said that it expects to receive a 510(k) clearance from the FDA by the end of June.
It also recently made its first commercial hire, tapping Paul Mullen as VP of sales. Mullen was previously sales director at the endovascular device developer Inari Medical, before its recent $4.9 billion acquisition by Stryker. Microbot also raised $13 million through a direct offering on the Nasdaq in February
The company has also been studying Liberty’s potential in telesurgery, with the operator and simulated patient located five miles apart, through a collaboration with Corewell Health.