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Microbot Medical Announces Final Data From Its Recent Animal Study Data supports next regulatory steps for the LIBERTY Robotic System

Key Takeaway: Microbot Medical Inc. announced that the data from an animal study of its LIBERTY Robotic System is promising, indicating the system's potential to improve surgical procedures. The report showed positive feedback from physicians and no adverse events during tests. However, some histopathology results were equivocal, suggesting that physiological responses could complicate interpretations. The company plans to leverage this data to pursue a U.S. Investigational Device Exemption.
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POSITIVE FACTORS

  • The LIBERTY Robotic System received overwhelmingly positive feedback from physicians during the animal study.
  • There were no observable immediate intraoperative adverse events or harm to the test subjects.
  • The study results support moving forward with next phases towards U.S. regulatory submission.

CONCERNS & RISKS

  • The histopathology report showed equivocal results possibly related to unusual physiological animal responses.
  • There is uncertainty in the results and regulatory pathways, which could affect future studies.
  • The company may face challenges in recruiting physicians for future regulatory studies.

Full Press Release Details

Medical Announces Final Data From Its Recent Animal Study
supports next regulatory steps for the LIBERTY Robotic System
Mass., May 5, 2023 - Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY Robotic System, the
first single-use endovascular robotic system, has received the histopathology report from the European-based MedTech research laboratory
that performed the animal study for the LIBERTY Robotic System in October 2022.
the animal study, the physicians conducted 63 navigations to the targeted sites using the investigational LIBERTY Robotic System and
performed an equal number of procedures manually. The LIBERTY Robotic System received overwhelmingly positive feedback from participating
physicians, and there were no observable immediate intraoperative adverse events, or harm, to the test subjects.
new data from the report, which included histopathology data (the microscopic examination of tissue to study the manifestations of disease),
exhibited equivocal results which were identified as related to unusual physiological animal responses in both manual and robotic test
Company believes the results of the study allow it to move forward and focus on the next phases to ultimately include a U.S.-based pivotal
Company, together with its regulatory experts and consultants, believe a larger sample size and robust data generated by this study will
advance the company's efforts towards the submission of Investigational Device Exemption (IDE) with U.S. Food and Drug Administration
Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies,
with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within
LIBERTY Robotic System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the
need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes
the LIBERTY Robotic System's remote operation has the potential to be the first system to democratize endovascular interventional
information about Microbot Medical is available at http://www.microbotmedical.com.
to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities
for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, 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. Any statements that are not historical fact (including, but not limited to statements that
contain words such as "will," "believes," "plans," "anticipates," "expects"
and "estimates") should also be considered to be 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 and the One & Done technologies, the outcome of its studies to evaluate LIBERTY, the One &
Done technologies and other existing and future technologies, any failure or inability to recruit physicians and clinicians to
serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, uncertainty in the results
of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, uncertainty resulting from the COVID-19 pandemic,
need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot
Medical can be found 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 web site at www.sec.gov. Microbot Medical disclaims any intent
or obligation to update these forward-looking statements, except as required by law.

Frequently Asked Questions

What is the LIBERTY Robotic System?

The LIBERTY Robotic System is the first single-use endovascular robotic system developed by Microbot Medical Inc.

What were the results of the recent animal study?

The animal study showed positive physician feedback, with no immediate adverse events noted.

What will Microbot Medical do next?

The company plans to pursue the next regulatory steps and an Investigational Device Exemption.

How does the LIBERTY System improve surgeries?

The system aims to simplify endovascular procedures, reducing equipment size, radiation exposure, and physician strain.

What did the histopathology report indicate?

The report revealed equivocal results due to unusual physiological responses in the test subjects.

Last updated: May 5, 2023