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Microbot Medical Partners with Baptist Hospital of Miami to Participate in its Pivotal Human Clinical Trial

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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.

Positive
  • Microbot Medical has received FDA approval to commence its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System.
  • Baptist Hospital of Miami, a leading U.S. hospital, has joined the trial as the second clinical site, enhancing the trial's credibility.
  • The partnership with prestigious institutions like Baptist Hospital of Miami and Brigham and Women's Hospital may bolster investor confidence.
  • Dr. Ripal Gandhi, a reputable medical professional, serves as the principal investigator, adding credibility to the trial.
Negative
  • The announcement lacks specific details on the trial timeline and potential delays, which could cause uncertainty for investors.

The collaboration between Microbot Medical and Baptist Hospital of Miami marks a significant step forward for the company’s pivotal human clinical trial. The LIBERTY® Endovascular Robotic Surgical System is being evaluated for its potential to transform endovascular procedures, which are minimally invasive treatments for conditions affecting blood vessels. The approval from the Institutional Review Board (IRB) and the signing of a Clinical Trial Agreement are important milestones in the clinical trial process, indicating that the study has met ethical and safety standards.

From a research perspective, the involvement of reputable institutions like Baptist Hospital of Miami and Brigham and Women's Hospital adds substantial credibility to the trial. With leading hospitals participating, there is a higher likelihood that the results will be taken seriously by the medical community and regulatory bodies. This could expedite the path to FDA approval if the trial outcomes are positive.

A key point to monitor is the speed and success of patient enrollment and the preliminary data that may emerge from these trials. Rapid enrollment suggests high interest and acceptance of the technology among medical professionals, which could be a positive indicator for its future market adoption.

Microbot Medical's partnership with Baptist Hospital of Miami for the clinical trial of their LIBERTY® system is a strategic move that could have substantial financial implications. The LIBERTY system, being an innovative robotic technology, targets a growing market in minimally invasive surgeries, which is expected to reach $28 billion by 2026. If successful, this technology could capture a significant share of this market, leading to substantial revenue growth for Microbot Medical.

However, investors should remain cautious about the inherent risks associated with clinical trials. While FDA approval to commence the trial is a positive step, it does not guarantee final market approval. The company's stock price may experience volatility based on trial progress updates and interim results. Long-term financial health will depend on successful trial outcomes, subsequent FDA approval and efficient market commercialization.

Financially, strong partnerships with leading hospitals can also enhance investor confidence and attract further institutional investment, potentially leading to improved stock performance in the short term.

Following the Company’s recent FDA approval to commence its pivotal human clinical trial, Baptist Hospital of Miami is the second clinical site to enroll in the trial

BRAINTREE, Mass., July 03, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board approval and signed a Clinical Trial Agreement with Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute.   This is the second announced site that will participate in the clinical trial for Microbot’s LIBERTY as part of its Investigational Device Exemption (“IDE”).   The Company had recently announced Brigham and Women's Hospital as another participating site.

The principal investigator at Baptist Hospital of Miami will be Ripal Gandhi, MD, FSVM. “I am very excited to participate in the trial. I believe this technology has the potential to change how we perform endovascular procedures,” said Dr. Gandhi.

“We believe the interest in the LIBERTY technology is overwhelming, as evident by the fast pace of enrolling and activating leading sites into the pivotal trial since we announced the IDE. We are excited for our partnership with Baptist Hospital of Miami, which is one of the leading hospitals in the United States,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical.

About Microbot Medical

Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage 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 the human body.

The Investigational LIBERTY® Endovascular Robotic Surgical 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® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.

Further information about Microbot Medical is available at http://www.microbotmedical.com.

Safe Harbor

Statements 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 the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, 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, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering 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.

Investor Contact:

Michal Efraty

IR@microbotmedical.com


FAQ

What recent FDA approval did Microbot Medical receive?

Microbot Medical recently received FDA approval to commence its pivotal human clinical trial for the LIBERTY Endovascular Robotic Surgical System.

Which hospitals are participating in Microbot Medical's clinical trial for LIBERTY?

Baptist Hospital of Miami and Brigham and Women's Hospital are participating in Microbot Medical's clinical trial for the LIBERTY Endovascular Robotic Surgical System.

Who is the principal investigator for the LIBERTY clinical trial at Baptist Hospital of Miami?

Dr. Ripal Gandhi is the principal investigator for the LIBERTY clinical trial at Baptist Hospital of Miami.

What is the purpose of Microbot Medical's LIBERTY Endovascular Robotic Surgical System?

The purpose of Microbot Medical's LIBERTY Endovascular Robotic Surgical System is to revolutionize how endovascular procedures are performed.

What significance does the partnership with Baptist Hospital of Miami hold for Microbot Medical's clinical trial?

The partnership with Baptist Hospital of Miami, a leading U.S. hospital, enhances the credibility of Microbot Medical's clinical trial for the LIBERTY Endovascular Robotic Surgical System.

Microbot Medical Inc.

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Biological Product (except Diagnostic) Manufacturing
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