Microbot Medical's Remote-Controlled Endovascular System Shows Promise in Pivotal Study

Microbot Medical has announced positive results from a pivotal study of its Liberty system, a remote-controlled device designed for endovascular procedures. The miniaturized, disposable system, currently under FDA review, demonstrated a 100% satisfaction rate among physicians in a clinical trial involving 20 patients undergoing peripheral vascular procedures.

Liberty System Design and Performance

The Liberty system is engineered to advance and control off-the-shelf guidewires and catheters during minimally invasive procedures. It allows interventionalists to operate the device from a safe distance, seated outside the radiation imaging field. In the single-arm clinical trial, the system achieved successful robotic navigation in every case, meeting the study's primary endpoint without the need for manual manipulation.

Key performance metrics from the study include:

• 92% reduction in operator radiation exposure, with an average decrease of 29.8 microsieverts
• Median navigation time of 3 minutes
• No device-related adverse events reported within three days post-procedure

Clinical Implications and Physician Feedback

The study results, presented as a late-breaking abstract at the annual meeting of the Society of Interventional Radiology in Nashville, highlight the potential of the Liberty system to enhance procedural safety and efficiency. Harel Gadot, President and CEO of Microbot Medical, expressed confidence in the market reception of Liberty, stating, "We are extremely pleased with the results in all aspects. 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."

Regulatory Progress and Commercial Preparations

Microbot Medical anticipates receiving FDA 510(k) clearance for the Liberty system by the end of June. In preparation for commercialization, the company has made strategic moves:

1. Appointed Paul Mullen as VP of Sales, leveraging his experience from endovascular device developer Inari Medical
2. Raised $13 million through a direct offering on the Nasdaq in February
3. Initiated a collaboration with Corewell Health to explore Liberty's potential in telesurgery, with successful tests conducted over a five-mile distance

As the medical device industry continues to innovate in minimally invasive procedures, Microbot Medical's Liberty system represents a significant advancement in remote-controlled endovascular technology, potentially offering improved safety for healthcare providers and enhanced precision for patients.