Microbot Medical® Concludes 2024 by Achieving Key Milestones Culminating in FDA Submission for the Commercialization of LIBERTY®
Microbot Medical (Nasdaq: MBOT) has concluded 2024 with significant achievements, including the FDA 510(k) submission for its LIBERTY® Endovascular Robotic System. Key milestones include receiving IDE approval, completing the ACCESS-PVI pivotal human clinical trial across three major US medical centers, and obtaining ISO 13485 certification. The company has initiated inventory build-up and completed two phases of telesurgery collaboration with Corewell Health. Additionally, Microbot entered an agreement with Emory University for autonomous robotics development. The company anticipates launching LIBERTY in Q2 2025 in the U.S., with plans for international expansion.
Microbot Medical (Nasdaq: MBOT) ha chiuso il 2024 con risultati significativi, tra cui la presentazione del 510(k) alla FDA per il suo LIBERTY® Endovascular Robotic System. I traguardi chiave includono l'approvazione dell'IDE, il completamento della sperimentazione clinica umana ACCESS-PVI in tre importanti centri medici USA e l'ottenimento della certificazione ISO 13485. L'azienda ha avviato l'accumulo di inventario e completato due fasi di collaborazione nella telesurgery con Corewell Health. Inoltre, Microbot ha stipulato un accordo con l'Università di Emory per lo sviluppo di robotica autonoma. L'azienda prevede di lanciare LIBERTY nel secondo trimestre del 2025 negli Stati Uniti, con piani per un'espansione internazionale.
Microbot Medical (Nasdaq: MBOT) ha concluido el 2024 con logros significativos, incluyendo la presentación del 510(k) ante la FDA para su LIBERTY® Endovascular Robotic System. Los hitos clave incluyen la aprobación del IDE, la finalización del ensayo clínico pivotal ACCESS-PVI en tres importantes centros médicos de EE. UU., y la obtención de la certificación ISO 13485. La empresa ha iniciado la acumulación de inventario y ha completado dos fases de colaboración en telesurgery con Corewell Health. Además, Microbot firmó un acuerdo con la Universidad de Emory para el desarrollo de robótica autónoma. La empresa prevé lanzar LIBERTY en el segundo trimestre de 2025 en EE. UU., con planes para una expansión internacional.
마이크로봇 메디컬 (Nasdaq: MBOT)는 2024년을 중요한 성과로 마무리하였으며, 그 중에는 LIBERTY® 혈관 내 로봇 시스템에 대한 FDA 510(k) 제출이 포함됩니다. 주요 이정표로는 IDE 승인 수령, 미국의 3대 의료 센터에서 진행된 ACCESS-PVI 중요한 인간 임상 시험 완료, ISO 13485 인증 획득 등이 있습니다. 이 회사는 재고 축적을 시작하였고 Corewell Health와의 원격 수술 협업의 두 단계를 완료했습니다. 또한 마이크로봇은 에모리 대학교와 자율 로봇 개발을 위한 계약을 체결했습니다. 이 회사는 2025년 2분기에 미국에서 LIBERTY를 출시할 계획이며, 국제 확장도 계획하고 있습니다.
Microbot Medical (Nasdaq: MBOT) a terminé l'année 2024 avec des réalisations significatives, y compris la soumission 510(k) à la FDA pour son LIBERTY® Système Robotique Endovasculaire. Parmi les jalons clés figurent l'approbation de l'IDE, l'achèvement de l'essai clinique pivot ACCESS-PVI dans trois grands centres médicaux aux États-Unis, et l'obtention de la certification ISO 13485. L'entreprise a entamé la constitution de stocks et a achevé deux phases de collaboration en télémédecine avec Corewell Health. De plus, Microbot a conclu un accord avec l'Université Emory pour le développement de la robotique autonome. L'entreprise prévoit de lancer LIBERTY au deuxième trimestre 2025 aux États-Unis, avec des projets d'expansion internationale.
Microbot Medical (Nasdaq: MBOT) hat das Jahr 2024 mit bedeutenden Erfolgen abgeschlossen, darunter die 510(k)-Einreichung bei der FDA für sein LIBERTY® Endovasculares Robotersystem. Zu den wichtigsten Meilensteinen zählen die Genehmigung des IDE, der Abschluss der ACCESS-PVI entscheidenden klinischen Studie an drei großen medizinischen Zentren in den USA sowie der Erhalt der ISO 13485-Zertifizierung. Das Unternehmen hat den Aufbau von Beständen eingeleitet und zwei Phasen der Telesurgery-Zusammenarbeit mit Corewell Health abgeschlossen. Darüber hinaus hat Microbot eine Vereinbarung mit der Emory-Universität zur Entwicklung autonomer Robotik getroffen. Das Unternehmen beabsichtigt, LIBERTY im 2. Quartal 2025 in den USA auf den Markt zu bringen, mit Plänen zur internationalen Expansion.
- Completed FDA 510(k) submission for LIBERTY® Endovascular Robotic System
- Successfully completed ACCESS-PVI pivotal human clinical trial in three major US medical centers
- Obtained ISO 13485 certification for quality management system
- Initiated inventory build-up for commercial launch
- Clear commercial launch timeline set for Q2 2025
- Commercial revenue generation delayed until at least Q2 2025
- Still pending FDA approval, creating regulatory uncertainty
- Additional regulatory approvals needed for international markets
Insights
The FDA 510(k) submission for LIBERTY® Endovascular Robotic System marks a critical regulatory milestone. The comprehensive preparation, including successful completion of the ACCESS-PVI pivotal trial across three prestigious medical centers and extensive R&D testing (biocompatibility, transportation validation, usability), demonstrates a robust regulatory package. The ISO 13485 certification further strengthens the company's quality management credentials, essential for commercialization.
The Q2 2025 targeted U.S. launch timeline appears realistic, considering typical FDA review periods for robotic surgical systems. The successful IDE approval and trial completion significantly de-risk the regulatory pathway. For retail investors: medical device companies typically experience stock price movements around key FDA decisions, with the 510(k) review typically taking 90-180 days.
The LIBERTY® system represents a significant advancement in endovascular robotics, targeting a growing market need for minimally invasive vascular procedures. The successful telesurgery collaboration with Corewell Health and autonomous robotics development with Emory University indicate strong future growth potential beyond initial commercialization.
The strategic focus on inventory build-up and operational infrastructure demonstrates proper scaling preparation. For context: the endovascular robotics market is projected to grow substantially, driven by increasing demand for precision procedures and remote surgery capabilities. The company's
Company Shifts Focus to Preparing for Commercial Launch as it Enters 2025
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
FAQ
When is Microbot Medical (MBOT) planning to launch the LIBERTY® Robotic System?
What major milestones did MBOT achieve in 2024?
Where was the ACCESS-PVI clinical trial for MBOT's LIBERTY system conducted?
What strategic partnerships has MBOT established for the LIBERTY system?
What regulatory certifications has MBOT received for the LIBERTY system in 2024?
