Microbot Medical Completes the Enrollment of Clinical Sites in Its Pivotal Human Clinical Trial with the Addition of Memorial Sloan Kettering Cancer Center
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.
- Completed enrollment of clinical sites for pivotal human trial of LIBERTY® system
- Addition of prestigious Memorial Sloan Kettering Cancer Center as final trial site
- Trial results expected to support FDA marketing submission and commercialization
- Principal investigator expresses confidence in robotics for interventional procedures
- None.
Insights
The enrollment of Memorial Sloan Kettering Cancer Center in Microbot Medical's clinical trial for the LIBERTY® Endovascular Robotic Surgical System is a significant step in the company's path to market. This trial aims to secure FDA approval by providing comprehensive clinical data. Memorial Sloan Kettering's involvement adds substantial credibility due to its reputation for excellence in cancer treatment and research.
IRB approval indicates that the trial meets ethical standards, ensuring patient safety and data integrity. Moreover, the participation of such a renowned institution may positively influence peer perception and investor confidence, potentially increasing the company's market valuation.
In the short term, investors might view this news as a positive catalyst, expecting progress towards FDA approval and commercialization. However, potential risks include trial delays or unfavorable results, which could impact the stock negatively.
Long-term, the success of this trial could open doors to a significant market in robotic-assisted interventions, offering substantial growth potential for Microbot Medical.
From a financial perspective, the clinical trial's progression is a positive development for Microbot Medical. The company's financial health and future revenue streams are closely tied to the success of the LIBERTY® system. Securing high-profile clinical sites like Memorial Sloan Kettering enhances the project's credibility, which could lead to increased investor interest and potential funding opportunities.
It is important to monitor the trial's cost management and any subsequent capital raises to fund ongoing research. Investors should also consider the timelines for FDA approval and market entry, as delays could affect cash flow projections.
In the context of stock performance, positive news from clinical trials typically leads to a short-term boost in stock price. However, the potential for volatility remains high, contingent on trial outcomes and regulatory decisions.
As the third and final clinical site, Memorial Sloan Kettering Cancer Center joins Brigham Women’s Hospital and Baptist Hospital of Miami as sites for the pivotal human clinical trial
BRAINTREE, Mass., July 18, 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 (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future marketing submission to the FDA and subsequent commercialization.
The clinical trial at Memorial Sloan Kettering Cancer Center will be led by Francois Cornelis, MD, PhD. “I’m a great believer in the future of robotics for interventional procedures and the value robotics can bring to physicians and our patients. I am excited to participate in the LIBERTY clinical trial.” said Dr. Cornelis. Dr. Cornelis will also serve as principal investigator for the overall LIBERTY clinical trial.
“We are excited to have a hospital the caliber of Memorial Sloan Kettering Cancer Center partnering with us to complete the enrollment of the clinical sites in our trial,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical.
The Company previously announced that Brigham and Women's Hospital in Boston, and Baptist Hospital of Miami are both enrolled in the trial and have performed clinical cases.
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
FAQ
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