Microbot Medical's LIBERTY® Trial Completion and Future Plans
Microbot Medical Completes Pivotal Clinical Trial for LIBERTY®
Microbot Medical Inc. today proudly announced the successful completion of its ACCESS-PVI human clinical trial, which evaluated the LIBERTY® Endovascular Robotic Surgical System. This significant milestone positions the company for its next steps as it gears up for a commercial launch.
Fast-Tracking Commercial Strategy
After successfully enrolling and following up on patients in the trial, Microbot Medical is now accelerating its go-to-market strategy. The company is not only finalizing its 510(k) submission to the U.S. Food and Drug Administration (FDA) by the end of 2024, but it is also enhancing its commercial infrastructure to support the launch of LIBERTY®.
Key Insights from the Trial
Juan Diaz-Cartelle, the Chief Medical Officer, shared insights on the performance of LIBERTY® throughout the study, emphasizing the positive feedback from participating physicians. The enthusiasm and commitment from investigators were crucial to the trial's success, and the upcoming medical conference in early 2025 will showcase the results.
Leadership in Healthcare Innovation
Harel Gadot, the Chairman and CEO, expressed pride in the company’s progress. He acknowledged the pivotal nature of this achievement for Microbot Medical. The next immediate objective is to prepare and submit the necessary documentation to the FDA, aiming for a clearance expected in the second quarter of 2025.
Details of ACCESS-PVI Trial
The ACCESS-PVI trial was a multi-center, single-arm study aimed at assessing the safety and performance of LIBERTY® in patients undergoing Peripheral Vascular Interventions. The positive results garnered throughout the trial not only support the upcoming FDA submission but are also critical for future commercialization efforts. The company extends gratitude to all patients, physicians, and clinical sites involved.
About Microbot Medical Inc.
Microbot Medical Inc. is a pivotal player in the medical device field, specializing in revolutionary micro-robotic technologies designed to enhance patient outcomes and improve accessibility through minimally invasive approaches. The innovations introduced through the LIBERTY® System aim to redefine how surgical robotics facilitate endovascular procedures, minimizing the need for expansive and costly capital equipment.
The Future of Endovascular Procedures
Microbot Medical's LIBERTY® System is set to revolutionize endovascular interventional procedures by mitigating radiation exposure, reducing physician strain, and democratizing access to advanced surgical options. As the company prepares for the LIBERTY® launch, the medical community and patients alike eagerly await further developments.
Frequently Asked Questions
What is the LIBERTY® Endovascular Robotic Surgical System?
The LIBERTY® System is an innovative robotic surgical platform designed to enhance the execution of endovascular procedures, aiming to improve patient care and surgical efficiency.
When does Microbot Medical expect FDA clearance?
Microbot Medical anticipates receiving FDA clearance during the second quarter of 2025, following its planned 510(k) submission by the end of 2024.
How does the ACCESS-PVI trial contribute to Microbot Medical’s goals?
The ACCESS-PVI trial provides critical data that supports the safety and efficacy of the LIBERTY® System, which is essential for both FDA approval and future commercialization efforts.
Who were the key contributors to the LIBERTY® trial?
The success of the trial is attributed to the dedication of participating patients, physicians, and clinical sites, along with the efforts of Microbot Medical’s team.
What are the company’s long-term objectives following the trial?
Post-trial, Microbot Medical aims to finalize its FDA submission, build commercial infrastructure, and prepare for a successful market introduction of the LIBERTY® System.
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