Microbot seeks FDA approval for surgical robot following successful clinical trials

Microbot Medical has announced that it intends to file an application with the U.S. Food and Drug Administration (FDA) for its robotic surgical system by the end of 2024. This follows the successful completion of a pivotal clinical study involving human subjects. The ACCESS-PVI study, initially slated for completion by the end of October 2024, was concluded earlier than expected according to a ClinicalTrials.gov entry. Microbot has confirmed that all patients have been enrolled and followed up for the study. The company is now accelerating its market entry strategy for the endovascular robotic surgery system named LIBERTY. Dr. Juan Diaz-Cartelle, Chief Medical Officer of Microbot, indicated that the results of the clinical study are expected to be published in early 2025. He highlighted the company's satisfaction with LIBERTY's performance during the study. With the anticipated FDA approval in the second quarter of 2025, the company plans to build a commercial infrastructure and intensify distribution efforts. ACCESS-PVI evaluates the performance and safety of the LIBERTY system in human subjects undergoing peripheral vascular interventions in a prospective, multicenter, single-arm study. Microbot CEO Harel Gadot described the completion of the study as encouraging and emphasized the importance of preparing the FDA 510(k) submission by the end of the year. The company is also working on the development of remote control capabilities for the LIBERTY system to enable surgical procedures without the physical presence of a surgeon. A partnership with Corewell Health aims to develop these telerobotic features. According to an analysis by GlobalData, the market for robotic surgical systems is projected to grow from $3.3 billion in 2023 to $7.2 billion in 2033, with an average annual growth rate of 15.7%. This growth is driven by the trend towards less invasive procedures and an aging population. J&J MedTech is also preparing to enter the clinical study arena with its robot Ottava. The company plans to file for an investigational device exemption with the FDA in the second half of 2024. An update on this is still pending.