Microbot Medical Inc. 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 second quarter 2025. 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 wants to thank the patients, physicians and clinical sites for their participation in the trial.