Microbot Medical Shares Results From Pivotal Clinical Trial, Achieving 100% Robotic Navigation Success for the LIBERTY Endovascular Robotic System
Microbot Medical Inc. presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting. The study was performed at three leading medical centers in the U.S.; Memorial Sloan Kettering Cancer Center (New York, NY), Baptist Hospital of Miami (Miami, FL) and Brigham and Women’s Hospital (Boston, MA). The late-breaking podium presentation was given by Francois Cornelis, M.D., PhD, Director of the Neuro Vascular Interventional Radiology Program at Memorial Sloan Kettering Cancer Center.
The data presented concluded that robotic endovascular procedures using LIBERTY are feasible and significantly minimize radiation exposure.
Significant Highlights of the ACCESS-PVI Study
- Successful robotic navigation was achieved in every case (N=20), yielding a success rate of 100%, meeting the primary endpoint of the study.
- No Adverse Device Events (ADE=0%) were reported through the duration of follow-up.
- Mean difference in radiation exposure between operator and control was (-)29.8 µS, resulting in a mean 92% relative reduction in radiation exposure.
- Median robotic navigation time to target was 3 minutes.
- Participating physicians reported LIBERTY performed as planned with a 100% satisfaction rate.
“The ACCESS-PVI data and the performance of the system throughout the study reflect the hard work that the team has put into LIBERTY over the past few years,” commented Harel Gadot, Chairman, CEO and President. “We are extremely pleased with the results in all aspects. As we shift focus to building our commercial capabilities and preparing for launch, we are confident that LIBERTY will be well received in the market.”
“We are very satisfied with the clinical data, as well as with the investigators’ feedback in terms of the short learning curve and intuitive operation of the device,” commented Dr. Juan Diaz-Cartelle, the Company’s Chief Medical Officer. “We are looking forward to working with interventional physicians and staff upon FDA’s clearance.”
LIBERTY is an investigational device pending FDA 510(k) clearance, and is currently not available for sale in the U.S.
Microbot Medical Inc. (NASDAQ: MBOT) is a pre-commercial stage medical technology company with a vision to redefine endovascular robotics and improve the quality of care for millions of patients and providers globally. The Company has developed the world’s first single-use, fully disposable endovascular robotic system, which aims to eliminate traditional barriers to accessing advanced robotic systems. Further information about Microbot Medical is available at http://www.microbotmedical.com.
Total Page Views: 317
