Microbot Medical has announced, as part of the preparation for its anticipated U.S. Food and Drug Administration (FDA) and CE Mark submissions, that it recently shipped multiple LIBERTY Robotic System devices to a market-leading research laboratory to conduct the Company’s GLP pre-clinical trial. The comprehensive trial, which is anticipated to commence later this month, will be performed by a team of global leaders in the endovascular space at a state-of-the-art lab with FDA approved levels of planning, controlling, monitoring and reporting (GLP standards).
“We are very excited to commence the first step of our regulatory process leading to the anticipated clearances for our LIBERTY® Robotic system,” commented Harel Gadot, Chairman, CEO and President. “We are confident the collaboration with a world-leading research institute, coupled with the Key Opinion Leaders performing the study, will allow us to progress as planned.”
The Company expects the results of the GLP pre-clinical trial will further validate the successful outcomes from multiple prior animal feasibility studies performed.
Source: Microbot Medical.