Microbot Medical® Announces FDA Submission for the Commercialization of the LIBERTY® Endovascular Robotic System
Microbot Medical (Nasdaq: MBOT) has submitted a 510(k) premarket notification to the FDA for its LIBERTY® Endovascular Robotic System, following successful completion of a multi-center clinical trial. LIBERTY® is the world's first single-use, fully disposable robotic system for endovascular procedures.
The company anticipates FDA marketing clearance during Q2 2025, targeting over 2 million annual peripheral vascular procedures in the U.S. The system eliminates the need for expensive capital equipment, reduces radiation exposure to medical staff, improves ergonomics, and aims to lower procedure costs while increasing efficiency.
Microbot Medical (Nasdaq: MBOT) ha presentato una notifica pre-commerciale 510(k) alla FDA per il suo LIBERTY® Endovascular Robotic System, a seguito del completamento con successo di uno studio clinico multicentrico. LIBERTY® è il primo sistema robotico monouso completamente riutilizzabile al mondo per procedure endovascolari.
L'azienda prevede l'autorizzazione al marketing da parte della FDA durante il Q2 2025, puntando a oltre 2 milioni di procedure vascolari periferiche all'anno negli Stati Uniti. Il sistema elimina la necessità di costosi apparecchiature capitali, riduce l'esposizione alle radiazioni per il personale medico, migliora l'ergonomia e mira a ridurre i costi delle procedure aumentando l'efficienza.
Microbot Medical (Nasdaq: MBOT) ha presentado una notificación previa a la comercialización 510(k) a la FDA para su LIBERTY® Endovascular Robotic System, tras la finalización exitosa de un ensayo clínico multicéntrico. LIBERTY® es el primer sistema robótico de un solo uso completamente desechable del mundo para procedimientos endovasculares.
La compañía anticipa la autorización de marketing por parte de la FDA durante el Q2 2025, apuntando a más de 2 millones de procedimientos vasculares periféricos anuales en los EE. UU. El sistema elimina la necesidad de equipos costosos, reduce la exposición a la radiación para el personal médico, mejora la ergonomía y busca reducir los costos de los procedimientos mientras aumenta la eficiencia.
마이크로봇 메디칼 (Nasdaq: MBOT)은 다기관 임상 시험의 성공적인 완료를 바탕으로 자신의 LIBERTY® 혈관 내 로봇 시스템에 대해 FDA에 510(k) 시장 진입 통지를 제출했습니다. LIBERTY®는 세계 최초의 일회용 완전 분리형 로봇 시스템으로 혈관 내 절차에 사용됩니다.
회사는 2025년 2분기에 FDA의 마케팅 승인을 예상하고 있으며, 미국에서 연간 200만 건 이상의 말초 혈관 절차를 목표로 하고 있습니다. 이 시스템은 비싼 자본 장비의 필요성을 없애고, 의료 직원의 방사선 노출을 줄이며, 인체공학을 향상시키고, 절차 비용을 낮추면서 효율성을 높이는 것을 목표로 합니다.
Microbot Medical (Nasdaq: MBOT) a soumis une notification préalable à la commercialisation 510(k) à la FDA pour son LIBERTY® Endovascular Robotic System, suite à l'achèvement réussi d'un essai clinique multicentrique. LIBERTY® est le premier système robotique à usage unique totalement jetable au monde pour les procédures endovasculaires.
L'entreprise prévoit une autorisation de marketing de la FDA au cours du Q2 2025, en visant plus de 2 millions de procédures vasculaires périphériques annuelles aux États-Unis. Le système élimine la nécessité d'équipements coûteux, réduit l'exposition aux radiations du personnel médical, améliore l'ergonomie et vise à réduire les coûts des procédures tout en augmentant l'efficacité.
Microbot Medical (Nasdaq: MBOT) hat eine 510(k) Vorabbenachrichtigung an die FDA für ihr LIBERTY® Endovascular Robotic System eingereicht, nach erfolgreichem Abschluss einer multizentrischen klinischen Studie. LIBERTY® ist das weltweit erste Einweg-Robotersystem, das vollständig für endovaskuläre Eingriffe verwendbar ist.
Das Unternehmen erwartet die Genehmigung zur Vermarktung durch die FDA im Q2 2025 und zielt auf über 2 Millionen jährliche periphere Gefäßverfahren in den USA ab. Das System beseitigt die Notwendigkeit für teure Investitionsgüter, reduziert die Strahlenexposition des medizinischen Personals, verbessert die Ergonomie und zielt darauf ab, die Verfahrenskosten zu senken und gleichzeitig die Effizienz zu steigern.
- First-to-market position with world's first single-use endovascular robotic system
- Successful completion of pivotal human clinical trial
- Targeting large market of 2M+ annual peripheral vascular procedures in U.S.
- Potential for reduced operational costs through elimination of capital equipment
- System designed to improve procedure efficiency and reduce radiation exposure
- FDA clearance not expected until Q2 2025
- No immediate revenue generation until commercial launch
- Pending regulatory approval creates uncertainty
Insights
The FDA 510(k) submission for LIBERTY® represents a significant milestone in the medical robotics industry. The single-use, disposable design addresses key market challenges including capital equipment costs and sterilization requirements. With a target market of over 2 million annual peripheral vascular procedures in the U.S., LIBERTY® could capture substantial market share by offering reduced radiation exposure and improved ergonomics for healthcare providers.
The successful completion of the multi-center trial and anticipated Q2 2025 FDA clearance timeline appears realistic given typical 510(k) review periods. The system's potential to reduce procedure costs while improving efficiency positions it well for hospital adoption, particularly in the current healthcare environment focused on cost containment. The disposable nature also provides a recurring revenue model rather than one-time capital equipment sales.
For a company with a market cap of just
The Q2 2025 timeline for potential FDA clearance provides a clear catalyst for investors to monitor. Key metrics to watch will include initial hospital adoption rates, pricing strategy and gross margins on the disposable units. The company's ability to scale manufacturing and establish distribution channels ahead of launch will be important for successful commercialization.
FDA 510(k) Submission Follows the Successful Completion of the Pivotal Human Clinical Trial
FDA 510(k) Clearance Anticipated During the Second Quarter of 2025
Company Preparing to Commence Commercialization Following FDA 510(k) Clearance
BRAINTREE, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative single use LIBERTY® Endovascular Robotic System, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for LIBERTY®. LIBERTY® is the world’s first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of its multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions.
The Company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.
“This is a pivotal milestone for our Company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” commented Harel Gadot, Chairman, CEO and President. “We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S. each year. We believe, based on feedback from physicians and the medical community, that LIBERTY® is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system.”
As the world’s first single-use, fully disposable endovascular robotic system, LIBERTY® eliminates the need for large and expensive capital equipment and streamlines customers’ access to robotics. With its remote control, LIBERTY® is designed to significantly reduce radiation exposure to physicians and staff, and improve ergonomics, which has the potential to reduce the physical strain on healthcare providers. The Company also believes that LIBERTY® has the potential to lower procedure costs, increase procedure efficiency and improve the overall quality of care.
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
FAQ
When did Microbot Medical (MBOT) submit its FDA 510(k) for LIBERTY?
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