Microbot Medical Partners with Brigham and Women's Hospital for Its Pivotal Human Clinical Trial
Microbot Medical has partnered with Brigham and Women's Hospital (BWH) to conduct a pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System. This follows the FDA's approval to commence the trial. BWH has received multiple LIBERTY systems and completed the Site Initiation Visit, which included training for clinical staff. Dr. Dmitry Rabkin will lead the study at BWH. Microbot is also engaging other leading centers to participate in the trial.
- FDA approval to commence the pivotal human clinical trial.
- Partnership with Brigham and Women's Hospital, a leading academic medical center.
- Multiple LIBERTY® systems have been delivered to BWH, ensuring inventory readiness.
- Completion of Site Initiation Visit and staff training at BWH.
- Ongoing efforts to engage additional leading centers for the trial.
- None.
Insights
The partnership between Microbot Medical and Brigham and Women's Hospital for the LIBERTY® Endovascular Robotic Surgical System trial is an important milestone in medical advancements. Endovascular surgery involves minimally invasive procedures to treat diseases of the blood vessels and the introduction of robotic technology in this field can significantly enhance precision and patient outcomes. Brigham and Women's Hospital's involvement adds credibility to the trial due to its reputation for pioneering medical research and clinical excellence.
The study's progress illustrates a potential breakthrough in surgical robotics, offering increased safety and reduced recovery times for patients. Additionally, Dr. Dmitry Rabkin’s expertise in angiography and interventional radiology underscores the trial’s robust scientific foundation. If successful, the LIBERTY® system could set new standards in endovascular procedures, potentially reducing procedural costs and improving patient accessibility.
This clinical trial announcement for the LIBERTY® Endovascular Robotic Surgical System is likely to attract investor interest. The FDA's approval to commence the trial is a significant regulatory milestone that validates Microbot Medical's technological innovations. The involvement of Brigham and Women's Hospital, a leading academic center, further strengthens market confidence in the trial’s outcomes.
The medical device market is highly competitive and successful trials can substantially elevate a company's market positioning. The readiness of multiple robotic systems and the engagement with additional centers highlight a well-structured trial approach, potentially expediting the path to commercialization. This could stimulate stock price appreciation as investors anticipate successful trial results and subsequent market entry.
From a financial perspective, this collaboration and impending clinical trial could significantly impact Microbot Medical's valuation. The successful execution of the trial can open doors to
However, it's important to consider the financial risks associated with clinical trials, such as trial delays or unfavorable outcomes. Investors should keep a close eye on trial progress updates and interim results. The strategic move to involve esteemed institutions like Brigham and Women's Hospital mitigates some risks, indicating thorough preparatory work and a strong clinical foundation.
Following FDA Approval to Commence the Clinical Trial, an Official Site Initiation Has Taken Place as Preparation for Patient Enrollment Advances
Multiple Robotic Systems Already Received by the Site to Allow Inventory Readiness in Support of Trial
BRAINTREE, Mass., June 20, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) announced its agreement with Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System, as part of its Investigational Device Exemption (“IDE”) application.
This development, previously announced on June 17, 2024, follows the U.S. Food and Drug Administration’s approval to commence Microbot’s pivotal human clinical trial.
The Company has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols and the use of the LIBERTY® Endovascular Robotic Surgical System. In addition, the first shipment of LIBERTY investigational systems arrived at BWH this week in support of the clinical trial. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology), will lead the study for the site as principal investigator at BWH.
“We are pleased to work with Dr. Rabkin and the team at Brigham and Women’s Hospital on this clinical study,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe their commitment to research and the advancement of science make them an ideal clinical study site.”
The Company is in the process of engaging additional leading centers to participate in the clinical trial.
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
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