Microbot Med Inc Stock Price, News & Analysis

Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, has received ISO 13485:2016 certification for its quality management system. This certification validates the company's robust quality system and indicates compliance with specific medical industry standards for risk assessment and process management in regulated medical product development and manufacturing.

The ISO 13485 certification is viewed as an initial step towards European regulatory compliance under the new Medical Device Regulation (EU MDR) and is required for CE mark approval for sales in the European Union. It also aligns with the FDA's revised QMSR, potentially streamlining Microbot's transition into this updated regulation.

Microbot Medical (Nasdaq: MBOT) has partnered with Emory University to explore autonomous robotics in endovascular procedures. The collaboration, led by Dr. Amir Pourmorteza, aims to integrate the LIBERTY® Endovascular Robotic Surgical System with imaging technology for autonomous endovascular procedures.

This initiative, known as Project Trita, combines CT-guidance, artificial intelligence, and medical robotics. The goal is to standardize outcomes, improve efficiencies, reduce radiation exposure, and democratize access to top-level healthcare. Microbot Medical's CEO, Harel Gadot, envisions this integration as a step towards creating an autonomous robotic system for endovascular procedures, potentially benefiting millions of patients globally.

Microbot Medical Inc. (Nasdaq: MBOT) has completed the enrollment of clinical sites for its pivotal human clinical trial of the LIBERTY® Endovascular Robotic Surgical System. Memorial Sloan Kettering Cancer Center in New York City joins Brigham and Women's Hospital in Boston and Baptist Hospital of Miami as the third and final site. The trial is part of an Investigational Device Exemption (IDE) for LIBERTY®, with results expected to support future FDA marketing submission and commercialization.

Dr. Francois Cornelis, who will lead the trial at Memorial Sloan Kettering and serve as principal investigator for the overall LIBERTY clinical trial, expressed enthusiasm for the future of robotics in interventional procedures. Microbot Medical's CEO, Harel Gadot, highlighted the significance of partnering with a prestigious institution like Memorial Sloan Kettering Cancer Center.

Microbot Medical has announced the completion of the first clinical procedure using its LIBERTY® Endovascular Robotic Surgical System at Baptist Hospital of Miami. This marks the second site to join the pivotal human clinical trial, following Brigham & Women's Hospital. The trial is designed to support the future FDA submission and commercialization of the LIBERTY® system. The procedure was performed by Dr. Ripal Gandhi. The company expressed optimism regarding the rapid progress, with two sites now enrolling patients within just a couple of weeks.

Microbot Medical (Nasdaq: MBOT) announced the successful enrollment of the first patient in its pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The procedure was conducted at Brigham and Women’s Hospital (BWH) in Boston, led by Dr. Dmitry Rabkin. This trial, part of an Investigational Device Exemption (IDE), aims to gather data to support the future FDA submission and commercialization of LIBERTY®. Juan Diaz-Cartelle, MD, Chief Medical Officer, highlighted this milestone as important for bringing LIBERTY® to U.S. physicians and expressed optimism for further patient enrollments.

Microbot Medical has announced a partnership with Baptist Hospital of Miami to participate in its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System. This follows recent FDA approval to start the trial. Baptist Hospital is the second site to enroll, joining Brigham and Women's Hospital. The trial has received Institutional Review Board approval, and a Clinical Trial Agreement has been signed. Dr. Ripal Gandhi will be the principal investigator. The LIBERTY technology aims to revolutionize endovascular procedures, with significant interest from leading healthcare institutions.

Microbot Medical has partnered with Brigham and Women's Hospital (BWH) to conduct a pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System. This follows the FDA's approval to commence the trial. BWH has received multiple LIBERTY systems and completed the Site Initiation Visit, which included training for clinical staff. Dr. Dmitry Rabkin will lead the study at BWH. Microbot is also engaging other leading centers to participate in the trial.

Microbot Medical has announced that Brigham and Women’s Hospital (BWH) in Boston will be a site for its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System as part of its Investigational Device Exemption (IDE) application. Dr. Dmitry Rabkin has been appointed as the principal investigator at BWH. The site initiation visit has been completed, and BWH staff have been trained on the clinical study protocols. Additionally, a shipment of LIBERTY investigational units has been delivered to BWH. Microbot Medical is also in the process of enlisting other leading centers for the clinical trial.

Microbot Medical (NASDAQ: MBOT) announced the closing of a $2.35 million registered direct offering priced at-the-market under Nasdaq rules, selling 1,566,669 shares at $1.50 per share. Concurrently, the company issued unregistered Series F preferred investment options for up to 3,133,338 shares at $1.50 per share, exercisable for two years. H.C. Wainwright & Co. acted as the exclusive placement agent. The company plans to use the net proceeds for the development and commercialization of the LIBERTY® Robotic System, expansion of its IP portfolio, and general corporate purposes.