Microbot Medical expects to submit an application to the US FDA for its robotic surgical system by the end of 2024 after wrapping up a pivotal human clinical trial.
The ACCESS-PVI study had been estimated to finish by the end of October 2024, according to a ClinicalTrials.gov entry, but last month Microbot said that it was on course to complete the trial ahead of prior expectations.
Microbot has now confirmed that it successfully completed enrolment and follow-up for all patients in the study, adding that it is “accelerating its go-to-market strategy” for the endovascular robotic surgical system named Liberty.
Microbot plans to share the results from the clinical trial in early 2025, according to chief medical officer Dr Juan Diaz-Cartelle, who added the the company was “very pleased with the performance of LIBERTY throughout the study”.
The US robotics company expects to begin building out commercial infrastructure, including ramping up sales efforts, upon FDA clearance, which it expects in Q2 2025.
ACCESS-PVI is a prospective, multi-centre, single-arm trial evaluating the performance and safety of Microbot’s LIBERTY system on human subjects undergoing peripheral vascular interventions.
Endovascular surgery is a minimally invasive procedure that uses catheters to access blood vessels for the treatment of vascular diseases. Microbot states that its surgical robot is designed to remove the need for large and expensive capital equipment.
Microbot CEO Harel Gadot said: “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.”
The company is also developing remote capabilities for the LIBERTY system, allowing the surgical procedure to take place without the physical presence of a surgeon. The company has an ongoing partnership with Corewell Health – Michigan’s largest healthcare system – to develop telerobotic functionality.
The robotic surgical systems market is projected to grow from $3.3bn in 2023 to $7.2bn in 2033 at a compound annual growth rate of 15.7%, according to GlobalData analysis. The growth of the robotic surgical systems market is attributed to a push for less-invasive procedures in a growing elderly population.
J&J MedTech is eyeing an entry into the clinical trial space with its robot called Ottava. The company said in 2023 it plans to submit an investigational device exemption application to the FDA in the second half of 2024 to start clinical trials. The company has not issued an update since.
