Microbot Medical® Receives Its First International Regulatory Approval for the Commercialization of the LIBERTY® Endovascular Robotic System
Rhea-AI Summary
Microbot Medical (Nasdaq: MBOT) received its first international regulatory approval for commercializing the LIBERTY Endovascular Robotic System in Israel.
The Israeli Ministry of Health’s AMAR Division clearance enables marketing in Israel and supports obtaining a Free Sale Certificate for submissions and commercial activities in additional global jurisdictions.
Positive
- Israeli AMAR approval grants marketing and commercialization rights for LIBERTY in Israel
- Approval enables a Free Sale Certificate to support submissions in additional jurisdictions
- Company targets completion of CE Mark certification by end of 2026 for EU expansion
- LIBERTY is described as the only FDA-cleared single-use robotic system for peripheral endovascular procedures
- Multiple hospitals in six U.S. states have already adopted the LIBERTY System
Negative
- CE Mark certification for EU commercialization is still pending, with completion targeted by end of 2026
News Market Reaction – MBOT
In the May 26 session, MBOT gained 5.85%, reflecting a notable positive market reaction. Argus tracked a peak move of +5.3% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 15 | Investor call announcement | Neutral | +0.0% | Planned conference call to review LIBERTY progress and address misrepresentations. |
| May 14 | First revenue reported | Positive | -14.8% | First LIBERTY commercial revenue and transition to Full Market Release. |
| May 05 | Adoption & sales hire | Positive | -0.5% | Multiple new accounts and appointment of VP Sales EMEA for LIBERTY. |
| Apr 30 | EMEA sales expansion | Positive | +2.5% | Hiring senior EMEA commercial executive and outlining CE mark plans. |
| Apr 22 | Guideline tailwind | Positive | +2.8% | New radiation-safety guidelines highlighting needs LIBERTY aims to address. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent LIBERTY-related commercial and regulatory updates have generally been positive, but price reactions have been mixed, with some commercially positive milestones followed by share price declines.
Over the last few months, MBOT has steadily communicated the commercialization build-out for the LIBERTY system. It reported first commercial revenue of $105,000 in Q1 2026 and transitioned from Limited to Full Market Release, with adoption across multiple U.S. states and growing recurring orders. Management has expanded sales infrastructure in EMEA and highlighted new occupational safety guidelines that support remote robotics. Today’s international regulatory clearance in Israel extends that commercialization narrative beyond the U.S. toward broader global markets.
Key Terms
endovascular medical
regulatory approval regulatory
ce mark regulatory
peripheral endovascular procedures medical
radioembolization medical
prostatic artery embolization medical
free sale certificate regulatory
marketing clearance regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Israel becomes the second jurisdiction and the first outside of the U.S. to grant marketing clearance for the LIBERTY System
The AMAR regulatory approval will enable the Company to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions
HINGHAM, Mass.,, May 26, 2026 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, announced that it has achieved a significant regulatory milestone as Israel becomes the second jurisdiction — and the first outside of the U.S. — to grant marketing clearance for the LIBERTY System. The regulatory approval from the Israeli Ministry of Health's AMAR Division, the authority responsible for medical device regulation in Israel, allows the Company to market and commercialize the LIBERTY System in Israel, which also enables the Company to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions. The Company continues to pursue CE Mark certification and is working toward completion by the end of 2026, in preparation for the next phase of commercial expansion into the EU market.
The expansion into international markets follows the successful launch of the LIBERTY System in the U.S. which continues to be the focused territory for the Company. Multiple accounts and hospitals in Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina have already adopted the LIBERTY System.
“This is an important regulatory milestone for the LIBERTY System and demonstrates that, as a Company, we are continuing to execute on our growth strategies and making meaningful progress toward our overall commercial objectives,” commented Harel Gadot, Chairman, CEO and President. “The AMAR approval gives us marketing clearance and supports commercialization efforts in Israel, and we are already in advanced discussions to expedite the commercialization process and accelerate the adoption of the system there, while leveraging this approval and experience to pursue additional relevant markets.”
LIBERTY is the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care.
Learn more at www.microbotmedical.com and connect on LinkedIn and X.
Safe Harbor
Statements to future financial and/or operating results, future adoption of products, 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 “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran 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.
Contacts:
IR@microbotmedical.com
Media@microbotmedical.com
