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Microbot Medical Enrolled the First Patient in its Pivotal Human Clinical Trial

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Microbot Medical (Nasdaq: MBOT) announced the successful enrollment of the first patient in its pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The procedure was conducted at Brigham and Women’s Hospital (BWH) in Boston, led by Dr. Dmitry Rabkin. This trial, part of an Investigational Device Exemption (IDE), aims to gather data to support the future FDA submission and commercialization of LIBERTY®. Juan Diaz-Cartelle, MD, Chief Medical Officer, highlighted this milestone as important for bringing LIBERTY® to U.S. physicians and expressed optimism for further patient enrollments.

Positive
  • Enrollment of the first patient in the pivotal human clinical trial for LIBERTY®.
  • Procedure successfully conducted at Brigham and Women’s Hospital, Boston.
  • Trial results expected to support the FDA submission and subsequent commercialization.
Negative
  • None reported in the press release.

The enrollment of the first patient in Microbot Medical’s pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System is an encouraging development for the company. This trial phase is important as it will generate the necessary data to support a future FDA submission. Achieving FDA approval is a significant milestone as it determines whether the product can be marketed in the U.S. healthcare system.

From a medical research perspective, the involvement of Brigham and Women’s Hospital, a prestigious academic medical center, lends credibility to the trial. The participation of Dr. Dmitry Rabkin further reinforces the trial’s legitimacy given his expertise in Angiography & Interventional Radiology. The successful completion of the first procedure indicates initial feasibility and safety, which are essential metrics at this stage.

If the trial results are positive, it could revolutionize endovascular surgeries by enhancing precision and reducing operative risks. However, investors should note that clinical trials often face unpredictable challenges, including patient recruitment and adverse events, which could delay the FDA submission.

Retail investors should be aware that while this news is promising, it does not guarantee immediate commercial success. It is a step forward, but the journey from trial to market can be long and complex.

From a financial standpoint, the enrollment of the first patient in the LIBERTY® pivotal human clinical trial is a positive indicator for Microbot Medical's future prospects. Successful clinical trials can lead to FDA approval, opening the doors for commercialization and potential revenue streams. Given the potential market size for advanced robotic surgical systems, this development could significantly impact the company's financial health. Medical robotics is a rapidly growing sector, with increasing adoption in hospitals seeking to improve surgical outcomes and operational efficiency.

However, it's important to weigh this against the costs associated with ongoing clinical trials. These trials are expensive and resource-intensive. Moreover, even with positive trial results, the regulatory process can be lengthy and unpredictable, which can delay commercialization and revenue generation. Investors should also consider the competitive landscape, as many companies are vying for a share in the medical robotics market.

In the short term, the news might positively affect Microbot Medical’s stock price due to increased investor optimism. Long-term benefits will depend on subsequent trial results, FDA approval and successful market penetration.

The first clinical case was performed at Brigham and Women’s Hospital

The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System

BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial.

The clinical trial at BWH is led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization.

“Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY® to U.S. physicians,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very pleased with the rapid pace of site activation, and I’m looking forward to enrolling additional patients in the near future.”

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 is the significance of Microbot Medical enrolling the first patient in its LIBERTY® pivotal human clinical trial?

Enrolling the first patient marks a significant milestone for Microbot Medical, aiming to gather data to support FDA submission and commercialize the LIBERTY® Endovascular Robotic Surgical System.

Where was the first LIBERTY® clinical trial procedure performed?

The first procedure was performed at Brigham and Women’s Hospital in Boston, Massachusetts.

Who led the first procedure in the LIBERTY® clinical trial?

Dr. Dmitry Rabkin, MD, PhD, Assistant Chief of Angiography & Interventional Radiology at Brigham and Women’s Hospital, led the first procedure.

What does Microbot Medical aim to achieve with the LIBERTY® clinical trial?

The trial aims to collect data to support the future FDA submission and commercialization of the LIBERTY® Endovascular Robotic Surgical System.

When did Microbot Medical announce the completion of the first procedure in its LIBERTY® clinical trial?

Microbot Medical announced the completion of the first procedure on July 08, 2024.

Microbot Medical Inc.

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