Microbot Medical, a company specialising in robotic medical technologies, has concluded 2024 with significant progress on key objectives. The most notable achievement is the submission of the 510(k) application to the US Food and Drug Administration (FDA) for the LIBERTY® Endovascular Robotic System, moving closer to its planned commercial launch in 2025.

The company outlined three primary goals for 2024: completing the FDA submission process, establishing infrastructure for pre-commercialisation, and implementing strategies to support long-term growth. Substantial advancements were made in all areas, building confidence in readiness for commercial objectives in the coming year.

Key Milestones Achieved in 2024

Regulatory Progress

• Gained FDA approval for an Investigational Device Exemption (IDE), enabling the commencement of the ACCESS-PVI pivotal human clinical trial.
• Successfully conducted the trial at three prominent medical centres in the US: Miami Baptist Hospital, Memorial Sloan Kettering Cancer Center, and Brigham and Women’s Hospital.
• Completed essential research and development (R&D) tests required for the 510(k) submission, covering areas such as biocompatibility, transportation validation, and usability.
• Submitted the 510(k) application to the FDA for the LIBERTY® system's commercialisation.

Infrastructure Development

• Achieved ISO 13485 certification for its quality management system, supporting the transition to commercial operations.
• Began building inventory and refining operational processes to prepare for market entry.
• Shared clinical trial data through professional conferences to raise awareness and engage with the medical community.
• Participated in key events, including the Society of Interventional Radiology (SIR) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

Strategic Initiatives

• Completed two phases of a telesurgery project with Corewell Health, successfully simulating procedures across a five-mile distance.
• Partnered with Emory University to advance autonomous robotics development.

These accomplishments position Microbot Medical for the LIBERTY® system's anticipated US launch in the second quarter of 2025. The company is also pursuing additional regulatory approvals outside the US to expand its global reach.

 

 

Source: globenewswire.com

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