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Microbot Medical Inc., the developer of the LIBERTY Endovascular Robotic Surgical System, is constructing on the momentum from the constructive outcomes of its good laboratory practices, or GLP, pre-clinical research. The corporate is including a medical analysis affiliate to help its pending investigational machine exemption, or IDE, submission to begin its first-in-human medical trial.
The medical analysis affiliate (CRA) will be a part of the Braintree Mass.-based firm‘s established medical group within the U.S. The group is led by Dr. Juan Diaz-Cartelle, chief medical officer of Microbot Medical.
“Following the profitable completion of our pivotal GLP pre-clinical trial, and as we’re within the remaining stage of submitting our IDE, having an in-house CRA is a key piece for establishing the proper infrastructure for medical trial execution” stated Diaz-Cartelle in a launch.
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Microbot Medical goals to enhance endovascular surgical procedures
Microbot Medical’s LIBERTY system goals to enhance the usage of surgical robotics in endovascular procedures. The system eliminates the necessity for giant, cumbersome, and costly capital tools, based on the firm. It could actually additionally scale back radiation publicity and doctor pressure.
In December 2023, Microbot Medical accomplished a pre-clinical research of its LIBERTY system. The pre-clinical research is a mandatory step towards Microbot Medical’s IDE submission to the U.S. Meals and Drug Administration (FDA). In the course of the research, three interventional radiologists used LIBERTY to carry out a complete of 96 robotic navigations.
The radiologists used LIBERTY to look at and consider goal vessels with surrounding tissue microscopically after subjecting them to procedures utilizing a spread of commercially accessible intravascular catheterization gadgets. All of those gadgets had been managed and manipulated with Microbot Medical’s system.
LIBERTY is a single-use endovascular system. No devoted infrastructure is required to make use of the system. This may decrease limitations to acquiring and utilizing the system, making the expertise accessible to extra healthcare suppliers, claimed Microbot Medical.
Microbot groups up with Corewell Well being
Microbot Medical is collaborating with Corewell Well being for a multi-phase mission to allow telerobotics between distant facilities. The settlement additionally consists of the mutual analysis of the LIBERTY system for distant procedures.
Corewell Well being is a not-for-profit well being system with greater than 60,000 staff, together with over 11,500 physicians and superior follow suppliers, and greater than 15,000 nurses. It stated it offers care and providers in 21 hospitals, over 300 outpatient areas, and a number of other post-acute services.
Microbot Medical stated it gives micro-robotic applied sciences to enhance medical outcomes for sufferers and enhance accessibility by way of the pure and synthetic lumens, or tubular constructions, inside the human physique.