February 08, 2024 - by Catie Corcoran

Microbot Medical Takes Step Towards Human Clinical Trial in US

08 February 2024

New York, February 08, 2024 - PRISM MediaWire - 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.

Microbot Medical Inc. - Prism MarketView

Microbot Medical Inc., a pre-clinical medical device company, researches, designs, and develops micro-robotics assisted medical technologies targeting the minim

Microbot Medical Submits an IDE Application to Gain FDA Approval to Commence Its Pivotal Clinical Trial in the US

The Investigational Device Exemption (IDE) application follows the completion of multiple activities necessary to file this applicationBRAINTREE, Mass., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, announced that it has filed an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA). The IDE application follows the completion of multiple preclinical activities per

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.

Microbot Medical Announced Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Were Met

The results of the study will support the Company’s IDE submission to the FDA to commence its human clinical studyBRAINTREE, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model. As previously a

“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.”

Harel Gadot, CEO, President and Chairman of Microbot Medical

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.

Home - Microbot Medical

At Microbot, our innovative robotic technologies aim to allow accessibility for patients and other stakeholders. Our goal is to improve patients' lives by removing the barriers to optimal care, starting with the world's first single-use endovascular robotic system.

PRISM MarketView does not provide investment advice.

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