Microbot Medical Announced Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Were Met
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Insights
The successful completion of Microbot Medical Inc.'s GLP pivotal pre-clinical study represents a significant step towards the advancement of the LIBERTY Endovascular Robotic Surgical System. The utilization of a porcine model adheres to the stringent regulatory standards set by the FDA for pre-clinical trials, which is a positive indicator of the company's commitment to meeting safety and efficacy benchmarks.
From a medical research perspective, the involvement of leading interventional radiologists and the achievement of positive histopathology outcomes provide a strong foundation for the subsequent stages of development. The transition from pre-clinical to clinical stages is critical, as it signifies the potential for the technology to be tested in human subjects, which is the ultimate test of its clinical applicability and safety profile.
Furthermore, the use of commercially available intravascular catheterization devices in conjunction with the robotic system during the study may suggest compatibility with existing medical equipment, potentially facilitating smoother integration into current medical practices upon approval.
Microbot Medical Inc.'s announcement is likely to be of keen interest to investors and stakeholders within the medical device sector. The progression to human clinical studies, pending FDA IDE submission, indicates a move towards commercialization which can have significant implications for the company's market positioning and financial performance.
Robotic surgical systems represent a growing market segment, with an increasing demand for precision and minimally invasive procedures. Microbot's successful pre-clinical results could position the company favorably against competitors, provided the human clinical trials yield positive results. The market's response to such milestones is typically positive, assuming the technology offers a clear benefit over existing solutions.
Investors will be watching closely for the FDA's response to the IDE submission, as regulatory approval is a major hurdle that can impact timelines and investment requirements. The company's stock price may reflect the market's perception of the potential risks and rewards associated with the clinical and regulatory progress of the LIBERTY system.
The transition from a research and development phase to a clinical stage can have profound financial implications for a biotech company like Microbot Medical Inc. The costs associated with human clinical trials are substantial and the company's ability to manage these expenses while advancing the LIBERTY Endovascular Robotic Surgical System is crucial for its financial health.
Investors should consider the potential for increased capital requirements, which may lead to fundraising activities such as stock offerings or partnerships. These actions can dilute existing shares or introduce new variables into the company's financial strategy. However, successful clinical trials can lead to FDA approval, which would be a catalyst for revenue generation and could justify the investments made during the development phases.
It is important to monitor the company's cash burn rate and funding strategies, as these will be key indicators of its ability to sustain operations through the capital-intensive stages of clinical trials and potential market entry.
The results of the study will support the Company’s IDE submission to the FDA to commence its human clinical study
BRAINTREE, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.
As previously announced on December 7, 2023, the study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically after they were subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via the LIBERTY Endovascular Robotic Surgical System.
“I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, Chief Medical Officer. “This gives us confidence to move forward to the next stage of human clinical studies.”
“Today’s announcement marks another important milestone for the Company, as we continue our transition from R&D and pre-clinical phase into the clinical, regulatory and pre-commercial phase,” commented Harel Gadot, CEO. “We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical trial, completing our transition to a clinically stage company.”
About Microbot Medical
Microbot 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 the human body.
The 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. 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 potential products, including LIBERTY, the outcome of its studies to evaluate LIBERTY, whether the Company’s core business focus program and cost reduction plan are sufficient to enable the Company to continue to focus on its LIBERTY technology while it stabilizes its financial condition and seeks additional working capital, 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, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, such as employees of Microbot and its vendors and business partners being called to active military duty, 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
+972-(0)52-3044404
IR@microbotmedical.com
FAQ
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