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     325  0 Kommentare Microbot Medical Announces Successful Initial Outcomes from Its Pivotal Pre-Clinical Study with the LIBERTY Robotic Surgical System

    • A total of 48 animal targets were reached with 100% usability and technical success and no visual acute intra-operative adverse events or complications
    • This pivotal study, together with the verification and validation studies, is expected to serve as the basis for the IDE submission to the FDA

    BRAINTREE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Robotic Surgical System, today announces the successful initial outcomes of using the LIBERTY Robotic Surgical System in its pivotal pre-clinical study.

    The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets. A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.

    The company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the verification and validation (V&V) process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the FDA, in order to commence its pivotal clinical trial in humans.

    "We are extremely pleased with the LIBERTY system performance during the pivotal pre-clinical study, both from the usability and technical outcomes as well as the lack of visual acute intraoperative complications. The system operated without any issues in all cases, achieving our initial objectives for the study," said Simon Sharon, CTO & GM. "We are continuing to take all necessary steps towards submitting our IDE application to the FDA and commencing our pivotal clinical trial."

    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 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 Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.

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    Microbot Medical Announces Successful Initial Outcomes from Its Pivotal Pre-Clinical Study with the LIBERTY Robotic Surgical System A total of 48 animal targets were reached with 100% usability and technical success and no visual acute intra-operative adverse events or complications This pivotal study, together with the verification and validation studies, is expected to serve …