Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System
Microbot Medical (Nasdaq: MBOT) has achieved a significant milestone with FDA 510(k) clearance for its LIBERTY® Endovascular Robotic System, the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The company plans to commence commercialization in Q4 2025, targeting an initial U.S. market of approximately 2.5 million annual peripheral vascular procedures.
The LIBERTY® pivotal study demonstrated remarkable results, including 100% success in robotic navigation to target, zero device-related adverse events, and a 92% reduction in physician radiation exposure. The system's remote design aims to improve ergonomics and reduce physical strain on healthcare providers while enhancing procedure efficiency and lowering costs.
Microbot Medical (Nasdaq: MBOT) ha raggiunto un traguardo importante ottenendo la clearance FDA 510(k) per il LIBERTY® Endovascular Robotic System, il primo sistema robotico monouso e controllato da remoto approvato dalla FDA per procedure endovascolari periferiche. L'azienda prevede di avviare la commercializzazione nel Q4 2025, rivolgendosi a un mercato statunitense iniziale di circa 2,5 milioni di procedure vascolari periferiche annue.
Lo studio pivotale su LIBERTY® ha mostrato risultati notevoli, tra cui il 100% di successo nella navigazione robotica verso l'obiettivo, assenza di eventi avversi correlati al dispositivo e una riduzione del 92% dell'esposizione dei medici alle radiazioni. Il design remoto del sistema mira a migliorare l'ergonomia e a ridurre l'affaticamento fisico degli operatori sanitari, oltre a incrementare l'efficienza delle procedure e contenere i costi.
Microbot Medical (Nasdaq: MBOT) ha alcanzado un hito importante al obtener la autorización FDA 510(k) para su LIBERTY® Endovascular Robotic System, el primer sistema robótico de un solo uso y operado de forma remota aprobado por la FDA para procedimientos endovasculares periféricos. La compañía planea iniciar la comercialización en el Q4 2025, apuntando a un mercado inicial en EE. UU. de aproximadamente 2,5 millones de procedimientos vasculares periféricos anuales.
El estudio pivotal de LIBERTY® mostró resultados destacables, incluyendo 100% de éxito en la navegación robótica hasta el objetivo, ausencia de eventos adversos relacionados con el dispositivo y una reducción del 92% en la exposición a radiación de los médicos. El diseño remoto del sistema busca mejorar la ergonomía y reducir el esfuerzo físico del personal sanitario, además de aumentar la eficiencia de los procedimientos y reducir costos.
Microbot Medical (Nasdaq: MBOT)는 말초 혈관 시술을 위한 최초의 FDA 승인 일회용 원격 조종 로봇 시스템인 LIBERTY® Endovascular Robotic System에 대해 FDA 510(k) 승인을 획득하는 중요한 성과를 달성했습니다. 회사는 2025년 4분기(Q4 2025)에 상용화를 시작할 계획이며, 초기 미국 시장을 연간 약 250만 건의 말초 혈관 시술으로 보고 있습니다.
LIBERTY®의 주요 임상 연구는 목표 지점까지의 로봇 내비게이션 100% 성공, 기기 관련 이상사건 없음, 그리고 의사의 방사선 노출 92% 감소 등 뛰어난 결과를 보여주었습니다. 원격 설계는 의료진의 인체공학적 부담과 신체적 피로를 줄이고 시술 효율을 높이며 비용을 절감하는 것을 목표로 합니다.
Microbot Medical (Nasdaq: MBOT) a franchi une étape importante en obtenant l'autorisation FDA 510(k) pour son LIBERTY® Endovascular Robotic System, le premier système robotique à usage unique et contrôlé à distance approuvé par la FDA pour les interventions endovasculaires périphériques. La société prévoit de lancer la commercialisation au 4e trimestre 2025 (Q4 2025), visant un marché initial aux États-Unis d'environ 2,5 millions de procédures vasculaires périphériques par an.
L'étude pivot LIBERTY® a révélé des résultats remarquables, notamment 100% de réussite de la navigation robotique jusqu'à la cible, aucune complication liée au dispositif et une réduction de 92% de l'exposition des médecins aux radiations. La conception à distance du système vise à améliorer l'ergonomie et à réduire la fatigue physique des professionnels de santé, tout en augmentant l'efficience des procédures et en diminuant les coûts.
Microbot Medical (Nasdaq: MBOT) hat mit der FDA-510(k)-Zulassung für das LIBERTY® Endovascular Robotic System einen wichtigen Meilenstein erreicht – das erste von der FDA zugelassene Einweg-Robotersystem, das ferngesteuert für periphere endovaskuläre Eingriffe eingesetzt werden kann. Das Unternehmen plant, die Kommerzialisierung im Q4 2025 zu starten und zielt auf einen anfänglichen US-Markt von etwa 2,5 Millionen jährlichen peripheren Gefäßprocedure ab.
Die LIBERTY®-Pivotalstudie zeigte bemerkenswerte Ergebnisse, darunter 100% Erfolg bei der robotischen Navigation zum Ziel, keine gerätebedingten unerwünschten Ereignisse und eine 92%ige Reduktion der Strahlenbelastung für Ärzte. Das Fernbedienungs-Design soll die Ergonomie verbessern, die körperliche Belastung des medizinischen Personals verringern sowie die Verfahrensabläufe effizienter und kostengünstiger machen.
- First FDA-cleared single-use remotely operated robotic system for peripheral endovascular procedures
- Pivotal study showed 100% success rate in robotic navigation with zero device-related adverse events
- 92% reduction in radiation exposure for physicians
- Large addressable market of 2.5 million annual U.S. peripheral vascular procedures
- Commercial launch planned for Q4 2025
- Additional clinical data collection required during commercial launch
- Commercial infrastructure and activities still need to be completed
Insights
Microbot Medical's FDA clearance for LIBERTY® enables commercialization of their innovative robotic system, addressing a 2.5M procedure market opportunity.
The FDA's 510(k) clearance for Microbot Medical's LIBERTY® Endovascular Robotic System represents a significant regulatory milestone that transforms the company from development stage to commercial readiness. This is the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures, giving Microbot a first-mover advantage in this specific segment.
The pivotal study results that supported this clearance demonstrated 100% success in robotic navigation to target with zero device-related adverse events, along with a remarkable 92% reduction in physician radiation exposure. These clinical outcomes address two critical challenges in endovascular procedures: precision and occupational safety.
What makes this system particularly disruptive is its single-use design, which eliminates the traditional capital equipment model. Most robotic systems require substantial upfront investment and dedicated infrastructure, creating adoption barriers. LIBERTY®'s approach potentially offers a more flexible deployment model with lower initial barriers to entry for healthcare facilities.
The company's addressable market of 2.5 million annual U.S. peripheral vascular procedures presents substantial commercial potential. With commercial readiness activities having begun in Q2 2025, Microbot is positioned for a Q4 2025 launch. This timeline suggests the company has aligned its regulatory and commercial strategies effectively, minimizing the typical lag between approval and market entry.
MBOT's FDA clearance unlocks commercialization in a multi-billion dollar market with disruptive technology designed for broader adoption potential.
This FDA clearance transforms Microbot Medical from a clinical-stage to commercial-stage company, potentially triggering a fundamental revaluation. The LIBERTY® Endovascular Robotic System addresses the $2.4 billion peripheral vascular devices market with a solution that could accelerate robotic adoption through its innovative single-use approach.
The company's strategic timing is noteworthy - they've been executing commercial readiness since Q2 in anticipation of this approval, which should compress the typical lag between regulatory clearance and revenue generation. This proactive approach suggests management confidence in both the regulatory outcome and commercial potential.
What's particularly compelling is LIBERTY®'s business model. Unlike traditional capital equipment-based robotic systems that require multi-million dollar investments, their single-use platform potentially offers a more accessible entry point for healthcare facilities. This could drive faster market penetration across both high-volume centers and smaller facilities that have traditionally been priced out of robotics adoption.
The 92% reduction in radiation exposure addresses a significant occupational hazard for interventional specialists and could become a powerful adoption driver as hospitals face increasing pressure to improve workplace safety. Combined with perfect navigation success in the pivotal trial, these data points provide a strong foundation for marketing claims.
With commercial launch scheduled for Q4 2025, investors should monitor initial customer adoption metrics, pricing strategy, and gross margin profile of the disposable components to evaluate the long-term economics of this business model.
Accelerated Launch Readiness Plans Position Company for Commercialization during Q4 2025
The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually
CEO, President & Chairman to Present Live Webcast at the H.C. Wainwright Annual Investor Conference on September 9, 2025, at 9 AM ET.
HINGHAM, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer and manufacturer of the innovative LIBERTY® Endovascular Robotic System, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the LIBERTY® System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The FDA clearance positions the Company to commercialize LIBERTY® in the U.S., with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.
“Obtaining FDA 510(k) clearance for LIBERTY® marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” commented Harel Gadot, Chairman, CEO & President. “With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.”
The LIBERTY® pivotal study showed
The Company will attend the H.C. Wainwright Annual Investor Conference held in NYC from September 8-10, 2025. Mr. Gadot will present live on Tuesday, September 9th at 9:00am ET, and a live webcast may be accessed via the ‘Events’ section of the Company’s website at www.microbotmedical.com. Investors should reach out to their H.C. Wainwright sales representatives or contact mpolyviou@evcgroup.com to schedule a one-on-one meeting with Microbot Medical’s management team.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a breakthrough 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 provider 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 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, 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 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
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c01cb38f-28e3-4704-93bf-42dde06458f2
A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6731e329-813d-4c29-b1d1-c1c860a8ea31
FAQ
When did Microbot Medical (MBOT) receive FDA clearance for the LIBERTY® System?
What are the key benefits of Microbot Medical's LIBERTY® Robotic System?
What is the market size for Microbot Medical's LIBERTY® System in the US?
When will Microbot Medical (MBOT) begin commercialization of the LIBERTY® System?
What makes LIBERTY® unique in the medical device market?
