Michael Barbella, Managing Editor01.19.24
Microbot Medical Inc. is sharing additional positive outcomes in its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System.
The pivotal study was conducted by three leading interventional radiologists that used the LIBERTY Robotic Surgical System to reach 48 animal targets. In a series of visual testing, performed 72 hours after each procedure, examination of the animals treated with the LIBERTY Robotic Surgical System showed no visual evidence of vascular injury or any other visual adverse event.
This new data follows successful initial outcomes from the pivotal pre-clinical study. A total of six LIBERTY Systems were used in the study, and each was used to reach a total of eight targets. All six LIBERTY Systems performed flawlessly based on the initial outcomes, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.
Subject to a final report and completion of the verification and validation process, the Microbot Medical plans to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration to begin a pivotal clinical human trial.
"We are excited to share additional positive outcomes of our pivotal pre-clinical study. The absence of any visual evidence of vascular injury in the follow-up examination after 72 hours continues to reaffirm the safety and effectiveness of our technology. This milestone, together with the advancement of the verification and validation process, brings us one step closer to the submission of the IDE and commencing our pivotal clinical trial in humans," Microbot General Manager/Chief Technology Officer Simon Sharon said.
Microbot Medical Inc. is a pre-clinical medical device company specializing in micro-robotic technologies that aims to improve clinical outcomes for patients and increase accessibility through the body's natural and artificial lumens. The LIBERTY Robotic Surgical System is designed to improve the way surgical robotics are being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company believes the LIBERTY Robotic Surgical System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.
The pivotal study was conducted by three leading interventional radiologists that used the LIBERTY Robotic Surgical System to reach 48 animal targets. In a series of visual testing, performed 72 hours after each procedure, examination of the animals treated with the LIBERTY Robotic Surgical System showed no visual evidence of vascular injury or any other visual adverse event.
This new data follows successful initial outcomes from the pivotal pre-clinical study. A total of six LIBERTY Systems were used in the study, and each was used to reach a total of eight targets. All six LIBERTY Systems performed flawlessly based on the initial outcomes, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.
Subject to a final report and completion of the verification and validation process, the Microbot Medical plans to submit an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration to begin a pivotal clinical human trial.
"We are excited to share additional positive outcomes of our pivotal pre-clinical study. The absence of any visual evidence of vascular injury in the follow-up examination after 72 hours continues to reaffirm the safety and effectiveness of our technology. This milestone, together with the advancement of the verification and validation process, brings us one step closer to the submission of the IDE and commencing our pivotal clinical trial in humans," Microbot General Manager/Chief Technology Officer Simon Sharon said.
Microbot Medical Inc. is a pre-clinical medical device company specializing in micro-robotic technologies that aims to improve clinical outcomes for patients and increase accessibility through the body's natural and artificial lumens. The LIBERTY Robotic Surgical System is designed to improve the way surgical robotics are being used in endovascular procedures by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The company believes the LIBERTY Robotic Surgical System’s remote operation can potentially be the first system to democratize endovascular interventional procedures.