Microbot Medical Submits FDA IDE Application, LIBERTY Vascular Intervention Robot

Microbot Medical Inc., a medical device company focused on micro-robotics, announced on February 5, 2024 that it has submitted an application for an Investigational Medical Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA). This is an important step in the company's development of LIBERTY, the first disposable robotic system for vascular interventional procedures.

Prior to this, Microbot Medical had already published preliminary results of its preclinical study in October 2023 and completed the entire study on December 7th. The study followed strict FDA guidelines, including trials conducted on pigs. During the course of the study, three interventional radiologists performed a total of 96 LIBERTY robotic navigation maneuvers, successfully manipulated a variety of commercially available endovascular catheterization devices, and performed exhaustive microscopic examinations and evaluations of the target vessels and their surrounding tissues.

Microbot Medical announced at the end of December 2023 that it had successfully completed key GLP (Good Laboratory Practice) preclinical studies. This IDE filing follows the completion of several preclinical studies designed to provide preliminary safety and efficacy information. Once FDA approval is granted, the company will be able to begin its pivotal human clinical trial in the United States.

Harel Gadot, CEO, president and chairman of Microbot Medical, said this is a significant milestone for the company and an important step on the road to advancing the LIBERTY vascular interventional surgery robot toward FDA approval.

LIBERTY Surgical Robot

LIBERTY is the world's first completely disposable robotic system for neurovascular, cardiovascular and peripheral vascular surgery. The system is simple to use, the instruments are lightweight, and its One & Done guidewire technology eliminates the need for multiple consumables and greatly reduces maintenance costs. LIBERTY can even be mailed back to Microbot Medical for recycling after each procedure. This is one of the reasons why LIBERTY was created in the first place: to reduce hospitals' investment in fixed assets.

The LIBERTY is equipped with a joystick like a game console and has the ability to be operated remotely, allowing healthcare workers to perform surgical procedures in another room, avoiding radiation exposure and cross-contamination with patients, thus freeing healthcare workers from heavy protective clothing.

The advantages of the LIBERTY Surgical Robot are not only that it is compact, does not take up surgical space, and is recyclable, but also that it can be operated remotely, which reduces the radiation exposure of the surgeon and even allows the operator to work from home. In addition, the LIBERTY Surgical Robot eliminates the need for heavy lead gowns and seated operation, reducing physical stress.The LIBERTY Surgical Robot is suitable for a wide range of vascular surgeries including neurovascular, cardiovascular, and peripheral vascular procedures. The LIBERTY Surgical Robot is an open system that can be used with a wide range of catheters and guidewires that are already on the market.

LIBERTY advantages listed

The advantages of LIBERTY surgical robot are mainly reflected in the following aspects:

1. Disposable: LIBERTY is the world's first completely disposable robotic system for neurovascular, cardiovascular and peripheral vascular surgery, eliminating the need for multiple consumables and reducing maintenance costs.

2. Recycling: The LIBERTY surgical robot can be mailed back to Microbot Medical after each procedure for recycling, reducing hospitals' investment in fixed assets.

3. Remote operation: Equipped with a joystick like a game console, it has the ability to be operated remotely, allowing healthcare workers to perform surgery in another room, avoiding radiation exposure and cross-infection with patients.

4. Reduced physical stress: eliminates the need to wear heavy lead suits and sit for operations, reducing the physical stress on healthcare workers.

5. Wide range of application: suitable for neurovascular, cardiovascular and peripheral vascular surgery.

6. Open system: LIBERTY Surgical Robot is an open system, which can be used with all kinds of catheters and guidewires already on the market.

7. Lightweight: The LIBERTY Surgical Robot is lightweight and does not take up much surgical space, making it easy for healthcare professionals to operate.

8. Home office: Thanks to its remote operation capability, the LIBERTY Surgical Robot can even be operated at home, if necessary.