Michael Barbella, Managing Editor11.08.22
Microbot Medical Inc. has purchased the endovascular assets of Nitiloop Ltd. The company did not disclose the deal's terms.
Due to the acquisition, as well as the start of its GLP animal trial, a rising interest in the LIBERTY Robotic System, and anticipated regulatory milestones—including initiation of its First-in-Human (FIH) trial—Microbot Medical is discontinuing its Self-Cleaning Shunt (SCS) project. The company is planning to focus its strategic efforts on the growing endovascular space and advancing the LIBERTY Robotic System to achieve its regulatory and commercial milestones, as well as expanding the LIBERTY ecosystem.
The SCS generally performed as expected during testing, both internally and externally, and the company believes it has potential clinical value as evidenced by the pre-clinical data submitted to the U.S. Food and Drug Administration (FDA). However, the conflicting commercialization pathways between LIBERTY and the SCS due to different hospital call points, and the anticipated lengthier regulatory process of the SCS, convinced Microbot Medical executives to focus the firm's strategic efforts on the LIBERTY Robotic System. Executives are confident the robotic technology will provide the company with a greater opportunity for success and future growth. The company plans to explore opportunities to sell the SCS assets, entering into joint ventures, licensing arrangements, spinning-off the assets into a new operating company, or discontinue the project altogether.
LIBERTY Robotic System Milestones through 2023
Microbot Medicalhas executed all of its primary objectives for the LIBERTY Robotic System in 2022 thus far, including the FDA pre-submission, commencement of the GLP animal study and the continued enhancement of its clinical infrastructure in the U.S. and Europe. As a result, the company believes it is on target to execute the following milestones through the end of 2023, in addition to those that continue to strengthen its position, such as its IP portfolio and internal core capabilities.
Microbot Medical Inc. 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 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.
Due to the acquisition, as well as the start of its GLP animal trial, a rising interest in the LIBERTY Robotic System, and anticipated regulatory milestones—including initiation of its First-in-Human (FIH) trial—Microbot Medical is discontinuing its Self-Cleaning Shunt (SCS) project. The company is planning to focus its strategic efforts on the growing endovascular space and advancing the LIBERTY Robotic System to achieve its regulatory and commercial milestones, as well as expanding the LIBERTY ecosystem.
The SCS generally performed as expected during testing, both internally and externally, and the company believes it has potential clinical value as evidenced by the pre-clinical data submitted to the U.S. Food and Drug Administration (FDA). However, the conflicting commercialization pathways between LIBERTY and the SCS due to different hospital call points, and the anticipated lengthier regulatory process of the SCS, convinced Microbot Medical executives to focus the firm's strategic efforts on the LIBERTY Robotic System. Executives are confident the robotic technology will provide the company with a greater opportunity for success and future growth. The company plans to explore opportunities to sell the SCS assets, entering into joint ventures, licensing arrangements, spinning-off the assets into a new operating company, or discontinue the project altogether.
LIBERTY Robotic System Milestones through 2023
Microbot Medicalhas executed all of its primary objectives for the LIBERTY Robotic System in 2022 thus far, including the FDA pre-submission, commencement of the GLP animal study and the continued enhancement of its clinical infrastructure in the U.S. and Europe. As a result, the company believes it is on target to execute the following milestones through the end of 2023, in addition to those that continue to strengthen its position, such as its IP portfolio and internal core capabilities.
- Complete follow-up of the previously disclosed GLP animal study and publish data on the study.
- Submit a follow-up FDA pre-submission package to align to the FDA’s required next steps.
- Initiate the engagement process, including IRB, of the first-in-human clinical sites, with a goal of exploring multiple sites in the U.S. and Europe for the conduct of the trial.
- Commence the first-in-human trial.
- Prepare for FDA submission.
Microbot Medical Inc. 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 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.