Microbot Medical (Nasdaq:MBOT) this week announced it received FDA approval to start its human clinical trial for its Liberty Endovascular Robotic Surgical System.
The pivotal human clinical trial is part of the company’s investigational device exemption application. It will be conducted in the U.S., and Microbot Medical has signed a clinical trial service agreement with “a leading academic medical center.” The company said it is also in the process of engaging more leading medical centers to participate in the trial.
“The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” CEO and President Harel Gadot said in a news release. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe.”
The company is also completing biocompatibility tests as required by its IDE application.
More about the surgical robotic system
Microbot designed the Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians.
Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures.
The company submitted the surgical robot for FDA investigation device exemption in February. It also recently expanded its U.S. operations ahead of the IDE submission to prepare for its next steps. Microbot has momentum from its positive good laboratory practices (GLP) pre-clinical study. Other recent news about Microbot includes a $2.154 million settlement of a lawsuit involving a securities purchase agreement.