U.S. Food and Drug Administration (FDA) Submission Expected by end of 2024

Clinical Data to be Presented at Medical Conference in Early 2025

BRAINTREE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY^® Endovascular Robotic Surgical System, today 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^® 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.”

“This is a monumental moment and a significant achievement for Microbot Medical,” commented Harel Gadot, Chairman, CEO and President. The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalize 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, 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.

About Microbot Medical

Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.

The Investigational LIBERTY^® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY^® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.