Microbot Medical Inc. MBOT recently announced that Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute, has completed its first clinical procedure in a patient utilizing the LIBERTY Endovascular Robotic Surgical System. Baptist Hospital of Miami is the second site to perform clinical procedures as part of MBOT’s pivotal human clinical trial.

The first clinical case was performed at Boston, MA-based Brigham and Women’s Hospital.

The latest announcement is a significant step for Microbot Medical toward its future submission to the FDA for the commercialization of the LIBERTY Endovascular Robotic Surgical System. It will become the first system to provide remote operation following a potential approval that will likely drive penetration for endovascular interventional procedures.

Significance of the Announcement

The clinical case at the Baptist Hospital of Miami was performed shortly after the announcement regarding its participation as a clinical trial site early this month. The trial is part of the Investigational Device Exemption (IDE) for LIBERTY.

Per Microbot Medical’s management, the progress of the clinical study, with two sites actively enrolling patients within a couple of weeks, is encouraging. The company expects its results to support the future submission to the FDA and subsequent commercialization of the LIBERTY system.

Industry Prospects

Per a report by Future Market Insights, the global robotic-assisted endovascular systems industry is expected to reach $214.7 million by 2033 from $94 million in 2023 at a CAGR of 8.6%. Factors like the increasing adoption of advanced robotic-assisted endovascular systems and the growing demand for innovative, minimally-invasive surgical procedures are likely to drive the market.

Given the market potential, the latest progress with its pivotal human clinical trial is expected to provide a significant boost to Microbot Medical’s business in the niche space.

Notable Developments

Last month, Microbot Medical received the FDA’s approval to proceed with its pivotal human clinical trial as part of its IDE application for its LIBERTY Endovascular Robotic Surgical System.

In April, Microbot Medical reported that the first phase of the previously announced collaboration with Corewell Health has been completed. The collaboration demonstrated the LIBERTY System's technical capabilities and outlined potential future applications in a range of endovascular interventions.

Microbot Medical, in February, announced that it has filed an IDE application with the FDA. The IDE application follows the completion of multiple preclinical activities performed to provide preliminary safety and effectiveness information, and its approval by the FDA would allow the company to commence its pivotal human clinical trial in the United States.