Microbot Medical Announces the Successful Completion of its Pivotal Human Clinical Trial; Accelerates Go-to-Market Strategy to Prepare for Commercial Launch of LIBERTY® during 2Q 2025
Microbot Medical Inc. (Nasdaq: MBOT) has successfully completed enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company is on track to file its 510(k) submission with the FDA by the end of 2024, with expected clearance during Q2 2025. Microbot Medical is accelerating its go-to-market strategy, planning to build commercial infrastructure upon FDA clearance.
The clinical trial results will be shared at a medical conference in early 2025. The company's Chief Medical Officer, Juan Diaz-Cartelle, MD, expressed satisfaction with LIBERTY®'s performance throughout the study. CEO Harel Gadot described the trial's conclusion as a monumental moment for Microbot Medical.
Microbot Medical Inc. (Nasdaq: MBOT) ha completato con successo l'arruolamento e il follow-up di tutti i pazienti nel suo studio clinico umano ACCESS-PVI per il LIBERTY® Sistema Chirurgico Robotico Endovascolare. L'azienda è sulla buona strada per presentare la sua richiesta 510(k) alla FDA entro la fine del 2024, con un'attesa approvazione durante il Q2 2025. Microbot Medical sta accelerando la sua strategia di ingresso nel mercato, programmando di costruire un'infrastruttura commerciale dopo l'approvazione della FDA.
I risultati dello studio clinico saranno presentati in una conferenza medica nei primi del 2025. Il Chief Medical Officer dell'azienda, Juan Diaz-Cartelle, MD, ha espresso soddisfazione per le prestazioni del LIBERTY® durante l'intero studio. Il CEO Harel Gadot ha descritto la conclusione dello studio come un momento monumentale per Microbot Medical.
Microbot Medical Inc. (Nasdaq: MBOT) ha completado con éxito la inscripción y el seguimiento de todos los pacientes en su ensayo clínico humano ACCESS-PVI para el Sistema Quirúrgico Robótico Endovascular LIBERTY®. La empresa está en camino de presentar su solicitud 510(k) a la FDA a finales de 2024, con una aprobación esperada durante el Q2 de 2025. Microbot Medical está acelerando su estrategia de entrada al mercado, planeando construir una infraestructura comercial tras la aprobación de la FDA.
Los resultados del ensayo clínico se compartirán en una conferencia médica a principios de 2025. El Director Médico de la empresa, Juan Diaz-Cartelle, MD, expresó su satisfacción con el rendimiento del LIBERTY® a lo largo del estudio. El CEO Harel Gadot describió la conclusión del ensayo como un momento monumental para Microbot Medical.
마이크로봇 메디컬(Microbot Medical Inc.) (Nasdaq: MBOT)은 LIBERTY® 혈관 내 로봇 수술 시스템의 ACCESS-PVI 인간 임상 시험에서 모든 환자의 등록과 후속 조치를 성공적으로 완료했습니다. 이 회사는 2024년 말까지 FDA에 510(k) 제출을 할 계획이며, 2025년 2분기에 허가될 것으로 예상하고 있습니다. 마이크로봇 메디컬은 FDA 허가 후 상업 인프라를 구축할 계획으로 시장 진입 전략을 가속화하고 있습니다.
임상 시험 결과는 2025년 초에 의료 회의에서 발표될 예정입니다. 회사의 최고 의료 책임자(Chief Medical Officer)인 후안 디아즈-카르텔(Juan Diaz-Cartelle, MD)은 연구 전반에 걸쳐 LIBERTY®의 성과에 대해 만족감을 표시했습니다. CEO 하렐 가도트(Harel Gadot)는 시험의 종료를 마이크로봇 메디컬을 위한 기념비적인 순간으로 묘사했습니다.
Microbot Medical Inc. (Nasdaq: MBOT) a terminé avec succès l'inscription et le suivi de tous les patients dans son essai clinique ACCESS-PVI pour le Système Chirurgical Robotic Endovasculaire LIBERTY®. L'entreprise est sur le point de soumettre sa demande 510(k) à la FDA d'ici la fin de 2024, avec une approbation attendue au cours du deuxième trimestre 2025. Microbot Medical accélère sa stratégie de mise sur le marché, prévoyant de construire une infrastructure commerciale après l'approbation de la FDA.
Les résultats de l'essai clinique seront présentés lors d'une conférence médicale début 2025. Le directeur médical de l'entreprise, Juan Diaz-Cartelle, MD, a exprimé sa satisfaction quant à la performance du LIBERTY® tout au long de l'étude. Le PDG Harel Gadot a qualifié la conclusion de l'essai de moment monumental pour Microbot Medical.
Microbot Medical Inc. (Nasdaq: MBOT) hat die Einschreibung und Nachverfolgung aller Patienten in seiner ACCESS-PVI-Studie für das LIBERTY® Endovaskuläre Roboter-Chirurgiesystem erfolgreich abgeschlossen. Das Unternehmen ist auf dem besten Weg, seinen 510(k) Antrag bis Ende 2024 bei der FDA einzureichen, mit einer erwarteten Genehmigung im Q2 2025. Microbot Medical beschleunigt seine Markteinführungsstrategie und plant, nach der Genehmigung durch die FDA eine Handelsinfrastruktur aufzubauen.
Die Ergebnisse der klinischen Studie werden auf einer medizinischen Konferenz Anfang 2025 vorgestellt. Der medizinische Direktor des Unternehmens, Juan Diaz-Cartelle, MD, äußerte sich zufrieden mit der Leistung des LIBERTY® während der gesamten Studie. CEO Harel Gadot beschrieb den Abschluss der Studie als monumentalen Moment für Microbot Medical.
- Successful completion of ACCESS-PVI human clinical trial for LIBERTY® system
- On track for FDA 510(k) submission by end of 2024
- Expected FDA clearance in Q2 2025
- Accelerating go-to-market strategy and commercial infrastructure development
- Positive performance of LIBERTY® throughout the study
- None.
Insights
The successful completion of Microbot Medical's pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System is a significant milestone. This achievement positions the company to file its 510(k) submission with the FDA by the end of 2024, potentially leading to commercial launch in Q2 2025. Key points to consider:
- The ACCESS-PVI trial's completion suggests the LIBERTY® system performed well in peripheral vascular interventions.
- FDA clearance, if obtained, would mark Microbot's entry into the competitive medical robotics market.
- The accelerated go-to-market strategy, including plans to build commercial infrastructure, indicates confidence in the product's potential.
- Presentation of clinical data at a medical conference in early 2025 will be important for gaining credibility within the medical community.
While promising, investors should note that FDA clearance is not guaranteed and the company will face challenges in commercialization and market penetration against established players in the surgical robotics field.
This news represents a potentially transformative event for Microbot Medical, a company with a current market cap of only
- Potential revenue generation starting in Q2 2025, assuming FDA clearance is obtained.
- Likely increase in operating expenses as the company builds out its commercial infrastructure.
- Possible need for additional funding to support commercialization efforts, which could lead to dilution for current shareholders.
- Potential for partnerships or licensing agreements with larger medical device companies, which could provide capital and distribution channels.
The stock may experience increased volatility as the market reassesses the company's value proposition. Long-term investors should closely monitor the FDA submission process, as approval would be a critical catalyst for the stock. However, given the company's small size and the competitive landscape, significant risks remain.
U.S. Food and Drug Administration (FDA) Submission Expected by end of 2024
Clinical Data to be Presented at Medical Conference in Early 2025
BRAINTREE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024.
The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including the hiring of a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance, which is expected during 2Q 2025.
“We are very pleased with the performance of LIBERTY® throughout the study,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer. “We want to thank all our investigators for their enthusiastic commitment to the trial. We expect to share the results of the clinical trial with the medical community and the public at a conference in early 2025.”
“This is a monumental moment and a significant achievement for Microbot Medical,” commented Harel Gadot, Chairman, CEO and President. The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalize the FDA 510(k) submission package so we can file it by the end of the year. Concurrently, we will deploy our go-to-market strategy and begin to build out a commercial infrastructure to ensure we are fully prepared to launch LIBERTY® upon the FDA’s clearance, which we expect during 2Q 2025.
ACCESS-PVI is a prospective, multi-center, single-arm, trial to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions. The trial will support the 510(k) submission to the FDA and subsequent commercialization. The Company wants to thank the patients, physicians and clinical sites for their participation in the trial.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.
The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.
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, 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, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, 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, need and ability to obtain future capital, 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.
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