Microbot Medical accelerates patient enrollment of human trial for LIBERTY

Microbot Medical announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human clinical trial for LIBERTY. As a result of the increased rate of patient enrollment, 80% of the patients have completed the follow up period, and the Company now anticipates completing the trial ahead of its prior expectation. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration by of the end of 2024. ACCESS-PVI is a prospective, multi-center, single-arm trial to evaluate the performance and safety of LIBERTY in human subjects undergoing Peripheral Vascular Interventions. The trial will support the 510(k) submission to the FDA and subsequent commercialization. The Company also announced that is has successfully completed all biocompatibility tests, as required by its Investigational Device Exemption application and received full approval for the IDE study from the FDA. The Company had previously disclosed that it had received approval from the FDA to commence its clinical trial, and in parallel complete biocompatibility testing. In parallel with the clinical trial, the Company is performing additional customary bench testing, and these final results will be included in the Company’s 510(k) submission.