Microbot Medical Expands US Clinical Infrastructure in Support of the Upcoming IDE Submission to Commence its First in Human Clinical Study
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Insights
The addition of a Clinical Research Associate (CRA) to Microbot Medical Inc.'s team is a strategic move that underscores the company's commitment to advancing its LIBERTY Endovascular Robotic Surgical System. The presence of an in-house CRA can streamline the process of navigating regulatory submissions, such as the Investigational Device Exemption (IDE), which is a critical step before commencing human trials in the United States.
The CRA's role will likely involve coordination of study protocols, ensuring compliance with regulatory bodies and maintaining data integrity. Their expertise is crucial to the successful execution of clinical trials, which can impact the speed at which the product reaches the market. For investors, the efficient progression through clinical trials can be a positive indicator of the company's potential for future growth and its ability to bring innovative medical technology to market.
Positive results from pre-clinical studies, such as the GLP (Good Laboratory Practice) trials mentioned, often lead to increased investor confidence as they suggest a higher likelihood of successful human trials. The hiring of a CRA, therefore, may be viewed as an investment in the company's operational efficiency and regulatory compliance, potentially reducing the time and cost associated with clinical trial management.
From a financial perspective, the timing of the CRA addition could be indicative of the company's readiness to move forward with its IDE submission. This progression in the clinical pipeline can affect the company's stock as it brings the product closer to commercialization, which is the ultimate goal for revenue generation. Stakeholders will be attentive to the outcomes of the upcoming human trials, as they will significantly influence the company's valuation and market potential.
The endovascular robotic surgical systems market is witnessing a growing demand due to the precision and efficiency these systems offer in minimally invasive surgeries. Microbot Medical's advancement to human clinical trials places the company in a competitive position within this niche market. The successful development of the LIBERTY system could disrupt the current market dynamics by offering a differentiated product that enhances surgical outcomes.
Market penetration will depend on the system's clinical efficacy, safety and cost-effectiveness compared to existing solutions. Long-term market adoption could be influenced by the system's performance in clinical trials and subsequent FDA approval. Therefore, the role of the CRA in ensuring the success of these trials cannot be overstated, as it directly correlates with the system's marketability and the company's future financial performance.
Following the recent positive results of its pivotal GLP pre-clinical study, the Company added a CRA to facilitate the company's first in human clinical study
BRAINTREE, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA). The CRA will join the already established clinical team in the USA, led by Dr. Juan Diaz-Cartelle, the Company’s Chief Medical Officer.
"Following the successful completion of our pivotal GLP pre-clinical trial, and as we are in the final stage of submitting our IDE, having an in house CRA is a key piece for establishing the right infrastructure for clinical trial execution" said Dr. Diaz-Cartelle, Chief Medical Officer.
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, 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 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
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