Microbot Medical Says it Expects to Finish its ACCESS-PVI Robotic Surgical System Clinical Trial Ahead of Schedule

MT Newswires Live09-30

Microbot Medical (MBOT) said Monday its expects to finish its ACCESS-PVI clinical trial ahead of schedule, and remains on track to file its 510(k) premarket medical device submission with the US Food and Drug Administration by the end of the year.

With 80% of patients having completed follow-ups, Microbot's ACCESS-PVI clinical trial for the Liberty Endovascular Robotic Surgical System is experiencing faster-than-anticipated patient enrollment, the company said. The ACCESS-PVI clinical trial is a propspective multi-center, single-arm study evaluating its Liberty system's safety and performance in human subjects undergoing peripheral vascular interventions, in support of its premarket medical device submission to the FDA.

The medical device company said it has completed all biocompatibility tests, as required by its Investigational Device Exemption application, and received full approval for the IDE study from the FDA. While conducting the clinical trial, the company has also received approval to conduct additional bench testing for inclusion in its 510(k) submission.

Shares of Microbot were up nearly 3% in recent Monday trading.

Price: 0.89, Change: +0.02, Percent Change: +2.83

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