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Microbot Medical Achieves Significant Regulatory Milestone for the LIBERTY® Robotic System; Files FDA Pre-Submission Package for Regulatory Pathway
Pre-Clinical Trial on Track for Third Quarter HINGHAM, Mass., March 31, 2022 (GLOBE NEWSWIRE) -- The operational momentum that Microbot Medical Inc. (Nasdaq:
About this update from Microbot Medical Inc.
[{"type":"text","content":"Pre-Clinical Trial on Track for Third Quarter\nHINGHAM, Mass., March 31, 2022 (GLOBE NEWSWIRE) -- The operational momentum that Microbot Medical Inc. (Nasdaq: MBOT) experienced at the end of 2021 has continued well into the 2022 first quarter. The Company filed its pre-submission package for the LIBERTY® Robotic System with the U.S. Food and Drug Administration (FDA), addressing the regulatory pathway for the LIBERTY® Robotic System. This is in line with the Company’s previously stated Q1 timeline. The Company expects to meet with the FDA following a normal review process to discuss the pre-submission and ensure the testing protocols and regulatory pathway are aligned with the FDA to obtain clearance for LIBERTY. “The significant progress we achieved in the first quarter demonstrates the team is highly focused on delivering key milestones on time,” commented Harel Gadot, Chairman, CEO and President. “The pre-submission filing with the FDA is an important milestone, and although it is the initial phase in the regulatory process, it gives us the confidence to commence implementing plans to scale up the Company’s organizational infrastructure to support future commercial success.” About Microbot Medical Inc. Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, focused primarily on both natural and artificial lumens within the human body. Microbot’s current proprietary technological platforms provide the foundation for the development of a Multi Generation Pipeline Portfolio (MGPP). Microbot Medical was founded in 2010 by Harel Gadot, Prof. Moshe Shoham, and Yossi Bornstein with the goals of improving clinical outcomes for patients and increasing accessibility through the use of micro-robotic technologies. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal se...