Microbot Medical Inc. announces key milestones, including FDA 510(k) submission, in preparation for LIBERTY's commercial launch in 2025.
Quiver AI Summary
Microbot Medical Inc. announced the successful completion of key milestones as it looks forward to the commercial launch of its LIBERTY® Endovascular Robotic System in 2025. The company submitted its FDA 510(k) application for commercial approval and received Investigational Drug Exemption approval to begin the ACCESS-PVI pivotal human clinical trial, which was successfully carried out in three major medical centers across the U.S. Additionally, Microbot has established pre-commercial infrastructure, including ISO 13485 certification and inventory buildup. The company has also progressed in strategic initiatives, such as a telesurgery collaboration with Corewell Health and a partnership with Emory University for developing autonomous robotics. With these advancements, Microbot Medical aims to position itself for a robust commercial launch and further regulatory approvals in international markets.
Potential Positives
- Successfully submitted FDA 510(k) approval for the LIBERTY® Endovascular Robotic System, a significant milestone towards commercialization.
- Completed the ACCESS-PVI pivotal human clinical trial at leading medical centers, enhancing credibility and paving the way for future approvals.
- Achieved ISO 13485 certification for quality management, demonstrating commitment to high standards and supporting market readiness.
- Launched strategic collaborations with Corewell Health and Emory University, positioning the company for innovative advancements and growth in its technology offerings.
Potential Negatives
- The company is still in a pre-commercial stage, indicating potential ongoing financial instability and uncertainty in achieving its commercial goals.
- There are significant risks associated with the success of its regulatory approval process, notably the uncertainty of receiving FDA 510(k) clearance.
- External factors, such as hostilities in the region mentioned, pose additional risks that could disrupt operations and growth plans.
FAQ
What are the key milestones achieved by Microbot Medical in 2024?
Microbot Medical achieved FDA 510(k) submission, IDE approval, successful clinical trials, and ISO 13485 certification among other milestones in 2024.
When is the anticipated launch of the LIBERTY® system?
The LIBERTY® Endovascular Robotic System is anticipated to launch in Q2 2025 in the United States.
What is the significance of the FDA 510(k) submission?
The FDA 510(k) submission is a crucial step for Microbot Medical to gain commercial approval to market the LIBERTY® system.
How is Microbot Medical preparing for commercialization?
Microbot Medical is establishing pre-commercial infrastructures and enhancing collaborations to support its commercialization efforts for LIBERTY®.
What collaborations has Microbot Medical formed to enhance its technology?
Microbot Medical partnered with Emory University on autonomous robotics and collaborated with Corewell Health for telesurgery initiatives.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MBOT Hedge Fund Activity
We have seen 6 institutional investors add shares of $MBOT stock to their portfolio, and 16 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- UBS GROUP AG added 44,493 shares (+444930.0%) to their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 29,295 shares (-100.0%) from their portfolio in Q3 2024
- THOROUGHBRED FINANCIAL SERVICES, LLC removed 27,250 shares (-52.2%) from their portfolio in Q3 2024
- VANGUARD PERSONALIZED INDEXING MANAGEMENT, LLC removed 15,494 shares (-100.0%) from their portfolio in Q3 2024
- VIRTU FINANCIAL LLC removed 13,379 shares (-100.0%) from their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC added 12,280 shares (+10.2%) to their portfolio in Q3 2024
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 10,404 shares (-100.0%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
BRAINTREE, Mass., Dec. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY
®
Endovascular Robotic System, concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) submission for FDA commercial approval of LIBERTY
®
, which the company believes will position the Company for continued success in 2025.
“As we entered 2024, the Company had three primary goals in our quest to ensure we are ready for the successful commercial launch of LIBERTY in 2025: 1) complete FDA 510(k) submission, 2) establish pre-commercial infrastructures, and 3) execute strategic initiatives to support future growth,” commented Harel Gadot, Chairman and Chief Executive Officer. “Thanks to the efforts of our team, coupled with a close collaboration with our internal and external stakeholders, I am very pleased with the progress we made throughout the year toward achieving these goals. I have a high level of confidence we will be positioned to meet our commercial objectives moving forward.”
The following are the key milestones the Company has reported achieving during the past 12 months:
Complete FDA 510(k) submission
Received Investigational Drug Exemption (IDE) approval from the FDA to initiate the ACCESS-PVI pivotal human clinical trial.
Successfully completed the ACCESS-PVI pivotal human clinical trial in three leading medical centers in the USA: Miami Baptist (Miami, FL), Memorial Sloan Kettering (NYC, NY) and Brigham & Women’s (Boston, MA).
Successfully completed the substantial R&D testing required for FDA’s 510(k) submission, including biocompatibility, transportation validation, and usability testing, among others.
Submitted 510(k) file to FDA for the commercialization of the LIBERTY
®
Endovascular Robotic System.
Establish pre-commercial infrastructures
Received ISO 13485 certification for our quality management system to support commercialization.
Initiated inventory build-up while improving operational infrastructure.
Submitted the ACCESS-PVI pivotal human clinical trial results to conferences in anticipation of sharing them publicly by leveraging these professional channels.
Attended several endovascular medical conferences, including the Society of Interventional Radiology (SIR) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
Execute strategic initiatives to support future growth
Completed Phase 1 and Phase 2 of the telesurgery collaboration with Corewell Health, culminating in a simulated procedure between two facilities located 5 miles apart.
Entered into an agreement with Emory University to collaborate on the development of autonomous robotics.
Based on these achievements, the Company believes it has laid the necessary groundwork to support its commercial objectives in 2025. The Company is anticipating the launch of LIBERTY in Q2 2025 in the U.S. and continuing its efforts to receive additional regulatory approval outside the U.S. to support future growth.
About Microbot Medical
®
Microbot Medical Inc. (NASDAQ: MBOT) is a pre-commercial stage medical technology company with a vision to improve the quality of care for millions of patients and providers globally. The Company has developed the world’s first single-use, fully disposable endovascular robotic system, which aims to eliminate traditional barriers to accessing advanced robotic systems.
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, commercialization 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, the Company’s need for and ability to obtain additional working capital to continue its transition to a commercially focused company, market conditions, risks inherent in the development and/or commercialization of the LIBERTY
®
Endovascular Robotic Surgical System, uncertainty in the results of regulatory pathways and regulatory approvals, including whether the FDA will grant 510(k) clearance to commercially market the LIBERTY
®
Endovascular Robotic Surgical System in the United States, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, 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:
IR@microbotmedical.com
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