Microbot Medical Inc. (Nasdaq: MBOT) has announced the successful completion of enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial, marking a significant milestone for the LIBERTY Endovascular Robotic Surgical System. The company anticipates filing its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024, potentially bringing a novel approach to endovascular procedures.
The ACCESS-PVI trial is a prospective, multi-center, single-arm study designed to evaluate the performance and safety of the LIBERTY system in patients undergoing peripheral vascular interventions. Data from this trial will be pivotal in supporting the 510(k) submission to the FDA, paving the way for commercialization.
LIBERTY System: Advancing Endovascular Surgery
The LIBERTY system is designed to improve surgical robotics in endovascular procedures by eliminating the necessity for large and expensive capital equipment. It also aims to reduce radiation exposure and physical strain on physicians, addressing key limitations of current endovascular techniques. The system's remote operation capabilities could potentially democratize endovascular interventional procedures, making them more accessible.
According to Harel Gadot, Chairman, CEO and President of Microbot Medical, the conclusion of the trial and physician feedback is an encouraging development. The company's immediate focus is on preparing and finalizing the FDA 510(k) submission package for filing by the end of the year.
Commercialization Strategy
Microbot Medical is also accelerating its go-to-market strategy in anticipation of potential FDA clearance in the second quarter of 2025. This includes building out commercial infrastructure and hiring a seasoned healthcare executive to lead sales efforts. The company expects to present the clinical data from the ACCESS-PVI trial at a medical conference in early 2025.
Juan Diaz-Cartelle, MD, Chief Medical Officer, expressed satisfaction with the performance of the LIBERTY system throughout the study and thanked the investigators for their commitment to the trial.
Market Opportunity
The robotic surgical systems market is projected to grow from $3.3 billion in 2023 to $7.2 billion in 2033, demonstrating a compound annual growth rate (CAGR) of 15.7%, according to GlobalData analysis. This growth is driven by the increasing demand for less-invasive procedures in an aging population.
