Microbot Medical Inc, developer of the innovative LIBERTY Endovascular Robotic System, concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) submission for FDA commercial approval of LIBERTY, which the company believes will position the Company for continued success in 2025.

“As we entered 2024, the Company had three primary goals in our quest to ensure we are ready for the successful commercial launch of LIBERTY in 2025: 1) complete FDA 510(k) submission, 2) establish pre-commercial infrastructures, and 3) execute strategic initiatives to support future growth,” commented Harel Gadot, Chairman and Chief Executive Officer. “Thanks to the efforts of our team, coupled with a close collaboration with our internal and external stakeholders, I am very pleased with the progress we made throughout the year toward achieving these goals. I have a high level of confidence we will be positioned to meet our commercial objectives moving forward.”

The following are the key milestones the Company has reported achieving during the past 12 months:

Complete FDA 510(k) submission

• Received Investigational Drug Exemption (IDE) approval from the FDA to initiate the ACCESS-PVI pivotal human clinical trial.
• Successfully completed the ACCESS-PVI pivotal human clinical trial in three leading medical centers in the USA: Miami Baptist (Miami, FL), Memorial Sloan Kettering (NYC, NY) and Brigham & Women’s (Boston, MA).
• Successfully completed the substantial R&D testing required for FDA’s 510(k) submission, including biocompatibility, transportation validation, and usability testing, among others.
• Submitted 510(k) file to FDA for the commercialization of the LIBERTY^® Endovascular Robotic System.

Establish pre-commercial infrastructures

• Received ISO 13485 certification for our quality management system to support commercialization.
• Initiated inventory build-up while improving operational infrastructure.
• Submitted the ACCESS-PVI pivotal human clinical trial results to conferences in anticipation of sharing them publicly by leveraging these professional channels.
• Attended several endovascular medical conferences, including the Society of Interventional Radiology (SIR) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

Execute strategic initiatives to support future growth

• Completed Phase 1 and Phase 2 of the telesurgery collaboration with Corewell Health, culminating in a simulated procedure between two facilities located 5 miles apart.
• Entered into an agreement with Emory University to collaborate on the development of autonomous robotics.

Based on these achievements, the Company believes it has laid the necessary groundwork to support its commercial objectives in 2025. The Company is anticipating the launch of LIBERTY in Q2 2025 in the U.S. and continuing its efforts to receive additional regulatory approval outside the U.S. to support future growth.