HINGHAM, Mass., Oct. 13, 2022 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) announced a major development milestone by completing the GLP animal study for the LIBERTY® Robotic System, the first disposable robotic system developed for endovascular procedures. The study was performed by a team of Key Opinion Leaders (KOLs) experienced in the endovascular space in a world-class MedTech research laboratory with the levels of planning, monitoring, monitoring, and reporting required by the FDA ( GLP standards), using a porcine model.
During the GLP animal study, physicians performed 63 predetermined navigations to the target sites using the LIBERTY experimental robotic system and manually performed an equal number of procedures. The performance endpoint of the LIBERTY robotic system after robotic navigation was successfully achieved for 58 of the 63 targets (92%), while 3 of the targets (4.8%) were not achieved due to technical issues and 2 (3.2%) were not achieved. terminated due to fluoroscopy (non-device related) issues. Selective intraoperative post-navigation angiograms of the target vessels showed no definitive evidence of acute vascular injury. Follow-up angiograms of these vessels on day 3 post-procedure showed normal vessel anatomy with no signs of injury. Initial post-mortem gross pathology examination of some of the target organs has shown preliminary results, which will be further investigated in ongoing histopathological analysis, and potentially additional preclinical study.
In addition to objective measurements, the performance and usability of the LIBERTY robotic system was subjectively rated by each of the physicians, with their ratings considering characteristics such as ease of navigation to the target, learning curve, and stability. of the system. For the target sites reached, the doctors rated the LIBERTY robotic system at the highest level.
“It was a very satisfying experience,” commented Dr. Sebastian Flacke, MD PhD, Tufts Medical School Professor of Radiology, Chief of Interventional Radiology, Vice President of Research, Lahey Hospital and Medical Center. “It gives you a very precise idea of what you’re doing with a lot of control.”
“Setup time is quick,” added Dr. Dmitry J. Rabkin, MD, Ph.D., FSIR, Associate Chief, Division of Angiography and Interventional Radiology, Department of Radiology, Brigham and Women’s Hospital, after his own experience with LIBERTY during the GLP study. “The learning curve seems to be easy. The overall experience was very good, delicate and precise.”
“We are very proud and delighted with the performance of LIBERTY during the GLP animal study,” commented Dr. Eyal Morag, Chief Medical Officer of Microbot. “It was exciting to watch my highly valued colleagues quickly adapt to performing procedures robotically, and their success in achieving goals is a testament to the accessibility of LIBERTY.”
The LIBERTY Robotic System is experimental and has not been cleared by the United States Food and Drug Administration for any use, and therefore is not commercially available in the United States or any other market. The Company plans to further support this study with additional preclinical and clinical data.
About Microbot Medical Inc.
Microbot Medical Inc. (NASDAQ: MBOT) is a preclinical medical device company specializing in transformational micro-robotic technologies, primarily focused on the natural and artificial lights of the human body. Microbot’s current proprietary technology platforms form the basis for the development of a Multi-Generation Pipeline Portfolio (MGPP).
Microbot Medical was founded in 2010 by Harel Gadot, Professor Moshe Shoham and Yossi Bornstein with the goal of improving clinical outcomes for patients and increasing accessibility through the use of micro-robotic technologies. More information about Microbot Medical is available at http://www.microbotmedical.com.
Statements regarding future financial and/or operational results, future growth in research, technology, clinical development and potential opportunities for Microbot Medical Inc. and its subsidiaries, and other statements regarding expectations, beliefs, future objectives, 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 securities laws. All statements that are not historical facts (including, but not limited to, statements that contain words such as “will”, “believe”, “plan”, “anticipate”, “expect ” and “believes”) should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of potential products, including LIBERTY, the result of its studies to evaluate LIBERTY and other existing and future technologies, uncertainty in the results of preclinical studies and clinical trials or regulatory pathways and regulatory approvals, uncertainty resulting from the COVID-19 pandemic, the need for and ability to securing future capital and maintaining intellectual property rights. Additional information about the risks Microbot Medical faces is available under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s website. at www.sec.gov. Microbot Medical disclaims any intention or obligation to update these forward-looking statements, except as required by law.