Pre-clinical medical device company Microbot Medical has obtained US Food and Drug Administration (FDA) approval to proceed with its pivotal human clinical trial for its LIBERTY robotic endovascular surgical system.
The trial is a significant step in the investigational device exemption (IDE) application for the company’s LIBERTY system.
Set to take place in the US, the clinical study will be conducted in collaboration with a leading academic medical centre, which has already signed a clinical trial service agreement with Microbot Medical.
Efforts are underway to engage additional prominent medical centres for the trial. Furthermore, the company is completing the necessary biocompatibility tests stipulated by its IDE application.
The LIBERTY system is designed to help physicians improve surgeries related to endovascular procedures.
It eliminates the need for large and expensive capital equipment and reduces physician’s strain and radiation exposure.
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Microbot Medical CEO, president and chairman Harel Gadot said: “The recent authorisation 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.
“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.”
In June 2023, Microbot secured funding worth NIS1.62m ($440,000) from the Israel Innovation Authority to further develop its manufacturing process for the LIBERTY system.
