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Microbot announces it completed enrollment, follow p for ACCESS-PVI trial

Microbot Medical announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration, FDA, by of the end of 2024. The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including the hiring of a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance, which is expected during 2Q 2025. “We are very pleased with the performance of LIBERTY(R) throughout the study,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer. “We want to thank all our investigators for their enthusiastic commitment to the trial. We expect to share the results of the clinical trial with the medical community and the public at a conference in early 2025.”

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