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U.S. Food and Drug Administration (FDA) Submission Expected by end of 2024 Clinical Data to be Presented at Medical Conference in Early 2025 BRAINTREE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024. The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the comme
Confirms the Company on Track for FDA 510(k) Submission by end of 2024 Completes All IDE required Tests and Receives Final IDE Approval from the FDA for the ACCESS-PVI Study BRAINTREE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human clinical trial for LIBERTY®. As a result of the increased rate of patient enrollment, 80% of the patients have completed the follow up period, and the Company now anticipates completing the trial ahead of its prior expectation. The Company remains
BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company expects to complete enrollment and follow up in the fourth quarter of 2024 and file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024. ACCESS-PVI is a prospective, multi-center, single-arm, clinical trial designed
4 - Microbot Medical Inc. (0000883975) (Issuer)
4 - Microbot Medical Inc. (0000883975) (Issuer)
4 - Microbot Medical Inc. (0000883975) (Issuer)
Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of the Investigational Device Exemption ("IDE") for LIBERTY®, and the Company expects its results will support the future marketing submission to the FDA and subsequent commercialization.The clinical trial at Memorial Sloan Kettering Cancer Center will be led by Francois Cornelis, MD, PhD. "I'm a great believer in
Second Site In Company's Pivotal Human Clinical Trial, Following Brigham & Women's Hospital, Supporting Future FDA Submission For Commercialization
SC 13G/A - Microbot Medical Inc. (0000883975) (Subject)
SC 13G - Microbot Medical Inc. (0000883975) (Subject)
BRAINTREE, Mass., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced the appointment of Dr. Juan Diaz-Cartelle as its new Chief Medical Officer (CMO), effective December 1, 2023. The hiring of Dr. Diaz-Cartelle, a U.S.-based physician, coincides with the transition of the Company focusing mainly on research and development in Israel to the Company increasing its U.S.-based activities, which includes its planned clinical trials for the LIBERTY® Endovascular Robotic Surgical System in the U.S., the regulatory process with the FDA and establishing the commercial foundations to enter
10-Q - Microbot Medical Inc. (0000883975) (Filer)
DEFA14A - Microbot Medical Inc. (0000883975) (Filer)
DEF 14A - Microbot Medical Inc. (0000883975) (Filer)