Microbot Medical has today announced that it has successfully completed enrolment and follow-up for all patients in its ACCESS-PVI human clinical trial.
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 US Food and Drug Administration (FDA) clearance, which is expected during the second quarter of 2025.
“We are very pleased with the performance of LIBERTY throughout the study,” commented Juan Diaz-Cartelle, chief medical officer at Microbot Medical. “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.”
“This is a monumental moment and a significant achievement for Microbot Medical,” commented Harel Gadot, chairman, chief executive officer and president. “The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalise the FDA 510(k) submission package so we can file it by the end of the year. Concurrently, we will deploy our go-to-market strategy and begin to build out a commercial infrastructure to ensure we are fully prepared to launch LIBERTY upon the FDA’s clearance, which we expect during 2Q 2025.”
ACCESS-PVI is a prospective, multicentre, 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 commercialisation. The company wants to thank the patients, physicians and clinical sites for their participation in the trial.
