Microbot Medical Takes Step Towards Human Clinical Trial in US
Surgical robotics company, Microbot Medical (Nasdaq: MBOT) has taken an important step closer to initiating a pivotal human clinical trial in the United States with the filing of an Investigational Device Exemption (IDE) application with the FDA. Microbot is the developer of the LIBERTY® Endovascular Robotic Surgical System.
Last month, the company announced the successful completion of its good laboratory practices (GLP) pivotal pre-clinical study using a porcine model. The study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations. Microbot said the preclinical results would allow the company to continue its transition from R&D and pre-clinical phase into the clinical, regulatory and pre-commercial phase.
Commenting on the application update, Harel Gadot, CEO, President and Chairman of Microbot Medical, said, “This is an important milestone for the company, and it is another step forward in our journey to achieve FDA clearance for the LIBERTY® Endovascular Robotic Surgical System.”
Microbot has completed multiple preclinical activities to provide preliminary safety and effectiveness information, and its approval by the FDA would allow the company to commence its pivotal human clinical trial in the United States.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.
The LIBERTY Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com.