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Microbot Medical, Inc. (NASDAQ: MBOT) is a pioneering pre-clinical medical device company focused on developing groundbreaking micro-robotic medical technologies. Established with the vision to transform minimally invasive surgeries—a fast-growing sector estimated to be close to $20 billion by 2015—Microbot Medical aims to provide cutting-edge micro-invasive technologies that assist physicians in targeting disease sites with unmatched precision. The company's innovative platforms, such as LIBERTY and the Self-Cleaning Shunt (SCS), are designed to improve surgical outcomes and the quality of life for millions of patients globally.
One of Microbot Medical's core technologies, the Virob platform, is an autonomous advancing micro-robot (AAMR) less than 1mm in diameter. This micro-robot can advance forward and backward autonomously, providing precise navigation through the body. Similarly, the LIBERTY Endovascular Robotic Surgical System aims to revolutionize endovascular procedures by eliminating the need for bulky and expensive equipment while reducing radiation exposure and physician strain.
Microbot Medical has been achieving significant milestones, including positive results from its pivotal GLP pre-clinical study and its recent Investigational Device Exemption (IDE) application to the FDA. These advancements pave the way for the company's first human clinical trials. Furthermore, the company has secured both domestic and global patents, fortifying its product portfolio and creating significant barriers to entry for competitors.
Microbot Medical is actively engaging in pre-commercial activities and strategic partnerships to ensure efficient commercialization channels for the LIBERTY system once it receives regulatory approval. The company is committed to advancing its technologies and aims to integrate future capabilities such as remote operations, imaging integration, and AI functionalities.
Despite challenges such as the COVID-19 pandemic and recent geopolitical events in Israel, Microbot Medical continues to meet its planned timelines and milestones. The company’s operations in Israel, the USA, and other parts of the globe remain uninterrupted, and it believes it will achieve regulatory and commercial milestones as scheduled.
For further information about Microbot Medical, please visit www.microbotmedical.com.
Microbot Medical Inc. (Nasdaq: MBOT) has successfully completed enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company is on track to file its 510(k) submission with the FDA by the end of 2024, with expected clearance during Q2 2025. Microbot Medical is accelerating its go-to-market strategy, planning to build commercial infrastructure upon FDA clearance.
The clinical trial results will be shared at a medical conference in early 2025. The company's Chief Medical Officer, Juan Diaz-Cartelle, MD, expressed satisfaction with LIBERTY®'s performance throughout the study. CEO Harel Gadot described the trial's conclusion as a monumental moment for Microbot Medical.
Microbot Medical Inc. (Nasdaq: MBOT) has announced an acceleration in patient enrollment for its ACCESS-PVI human clinical trial of the LIBERTY® Endovascular Robotic Surgical System. With 80% of patients having completed the follow-up period, the company expects to finish the trial earlier than anticipated. Microbot remains on track to file its 510(k) submission with the FDA by the end of 2024.
The company has successfully completed all biocompatibility tests required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. ACCESS-PVI is a prospective, multi-center, single-arm trial evaluating the performance and safety of LIBERTY® in peripheral vascular interventions. Microbot is also conducting additional bench testing, with results to be included in the 510(k) submission.
Microbot Medical Inc. (Nasdaq: MBOT) has reached a significant milestone in its pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company has successfully enrolled and completed follow-up for 50% of the patients in the ACCESS-PVI trial, which aims to evaluate the system's performance and safety in peripheral vascular interventions. Microbot Medical expects to:
1. Complete enrollment and follow-up in Q4 2024
2. File a 510(k) submission with the FDA by the end of 2024
3. Proceed with commercialization upon FDA approval
Dr. Dmitry Rabkin from Brigham and Women's Hospital praised the system's ease of use and quick set-up, noting a short learning curve. The company's Chief Medical Officer, Dr. Juan Diaz-Cartelle, expressed excitement about the milestone and physician feedback, confirming they remain on track for trial completion and FDA submission.
Microbot Medical Inc. (Nasdaq: MBOT) has entered a Phase 2 collaboration agreement with Corewell Health to advance remote telesurgery using the LIBERTY® Endovascular Robotic System. This follows the successful completion of Phase 1, which demonstrated LIBERTY's technical capabilities for endovascular interventions. The objective of Phase 2 is to develop and demonstrate new telesurgery capabilities by performing simulated cardiovascular interventional procedures across two Corewell Health facilities located 5 miles apart.
The project is led by Dr. Ryan Madder, who recently published a manuscript highlighting the technical success of coronary guidewire and stent delivery using LIBERTY in a pre-clinical study. Microbot Medical's CEO, Harel Gadot, emphasized that incorporating telesurgery capabilities is important to their long-term strategy for LIBERTY, aiming to increase access to care for patients in remote locations.
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.
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