Microbot Medical Announces the Successful Enrollment of 50% of the Patients in its Pivotal Human Clinical Trial for the LIBERTY Endovascular Robotic Surgical System
Microbot Medical Inc. (Nasdaq: MBOT) has reached a significant milestone in its pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System. The company has successfully enrolled and completed follow-up for 50% of the patients in the ACCESS-PVI trial, which aims to evaluate the system's performance and safety in peripheral vascular interventions. Microbot Medical expects to:
1. Complete enrollment and follow-up in Q4 2024
2. File a 510(k) submission with the FDA by the end of 2024
3. Proceed with commercialization upon FDA approval
Dr. Dmitry Rabkin from Brigham and Women's Hospital praised the system's ease of use and quick set-up, noting a short learning curve. The company's Chief Medical Officer, Dr. Juan Diaz-Cartelle, expressed excitement about the milestone and physician feedback, confirming they remain on track for trial completion and FDA submission.
Microbot Medical Inc. (Nasdaq: MBOT) ha raggiunto un traguardo significativo nel suo importante studio clinico umano per il LIBERTY® Endovascular Robotic Surgical System. L'azienda ha registrato con successo e completato il follow-up per il 50% dei pazienti del trial ACCESS-PVI, che mira a valutare le prestazioni e la sicurezza del sistema nelle interventi vascolari periferici. Microbot Medical prevede di:
1. Completare la registrazione e il follow-up nel Q4 2024
2. Presentare una domanda 510(k) alla FDA entro la fine del 2024
3. Procedere con la commercializzazione dopo l'approvazione della FDA
Il Dr. Dmitry Rabkin dell'ospedale Brigham and Women's ha elogiato la facilità d'uso e la rapida configurazione del sistema, notando una breve curva di apprendimento. Il Chief Medical Officer dell'azienda, Dr. Juan Diaz-Cartelle, ha espresso entusiasmo per il traguardo e il feedback dei medici, confermando che rimangono in linea con il completamento dello studio e la presentazione alla FDA.
Microbot Medical Inc. (Nasdaq: MBOT) ha alcanzado un hito significativo en su importante ensayo clínico humano para el Sistema Quirúrgico Robótico Endovascular LIBERTY®. La empresa ha inscrito con éxito y completado el seguimiento del 50% de los pacientes en el ensayo ACCESS-PVI, que busca evaluar el rendimiento y la seguridad del sistema en intervenciones vasculares periféricas. Microbot Medical espera:
1. Completar la inscripción y el seguimiento en el cuarto trimestre de 2024
2. Presentar una solicitud 510(k) a la FDA a finales de 2024
3. Proceder con la comercialización tras la aprobación de la FDA
El Dr. Dmitry Rabkin del Hospital Brigham and Women's elogió la facilidad de uso y la rápida configuración del sistema, observando una curva de aprendizaje corta. El Director Médico de la empresa, Dr. Juan Diaz-Cartelle, expresó su entusiasmo por el hito y la retroalimentación de los médicos, confirmando que siguen en camino para completar el ensayo y la presentación a la FDA.
Microbot Medical Inc. (Nasdaq: MBOT)는 LIBERTY® 혈관 로봇 수술 시스템에 대한 중요한 임상 시험에서 중대한 이정표를 달성했습니다. 이 회사는 ACCESS-PVI 시험의 환자 50%에 대한 등록을 성공적으로 완료하고 후속 조치를 마쳤습니다. 이 시험은 말초 혈관 개입에서 시스템의 성능과 안전성을 평가하는 것을 목표로 하고 있습니다. Microbot Medical은 다음과 같은 계획을 기대하고 있습니다:
1. 2024년 4분기까지 등록 및 후속 조치 완료
2. 2024년 말까지 FDA에 510(k) 제출
3. FDA 승인 후 상용화 진행
Brigham and Women's Hospital의 Dr. Dmitry Rabkin은 시스템의 사용 용이성과 빠른 설정을 칭찬하며 짧은 학습 곡선을 언급했습니다. 회사의 최고 의학 책임자 Dr. Juan Diaz-Cartelle는 이정표와 의사들의 피드백에 대한 기대감을 표명하며, 시험 완료와 FDA 제출 일정에 차질이 없음을 확인했습니다.
Microbot Medical Inc. (Nasdaq: MBOT) a atteint une étape importante dans son essai clinique humain décisif pour le Système Chirurgical Robotique Endovasculaire LIBERTY®. L'entreprise a réussi à inscrire et à compléter le suivi pour 50 % des patients dans l'essai ACCESS-PVI, qui vise à évaluer la performance et la sécurité du système lors des interventions vasculaires périphériques. Microbot Medical prévoit de :
1. Terminer l'inscription et le suivi au quatrième trimestre 2024
2. Déposer une soumission 510(k) auprès de la FDA d'ici la fin de l'année 2024
3. Procéder à la commercialisation après l'approbation de la FDA
Le Dr Dmitry Rabkin de l'hôpital Brigham and Women's a salué la facilité d'utilisation et la rapidité d'installation du système, notant une courte courbe d'apprentissage. Le directeur médical de l'entreprise, le Dr Juan Diaz-Cartelle, a exprimé son enthousiasme pour cette étape et le retour d'expérience des médecins, confirmant qu'ils restent sur la bonne voie pour terminer l'essai et soumettre leur demande à la FDA.
Microbot Medical Inc. (Nasdaq: MBOT) hat einen bedeutenden Meilenstein in seiner entscheidenden klinischen Studie mit Menschen für das LIBERTY® Endovasculäre Roboterchirurgiesystem erreicht. Das Unternehmen hat erfolgreich 50% der Patienten in der ACCESS-PVI-Studie rekrutiert und den Follow-up abgeschlossen, der darauf abzielt, die Leistung und Sicherheit des Systems bei peripheren vaskulären Eingriffen zu bewerten. Microbot Medical erwartet:
1. Die Rekrutierung und den Follow-up im vierten Quartal 2024 abzuschließen
2. Bis Ende 2024 einen 510(k) Antrag bei der FDA einzureichen
3. Mit der Kommerzialisierung nach der Genehmigung durch die FDA fortzufahren
Dr. Dmitry Rabkin vom Brigham and Women's Hospital lobte die Benutzerfreundlichkeit und die schnelle Einrichtung des Systems und bemerkte eine kurze Lernkurve. Der Chief Medical Officer des Unternehmens, Dr. Juan Diaz-Cartelle, äußerte sich begeistert über den Meilenstein und das Feedback der Ärzte und bestätigte, dass sie im Zeitplan für den Abschluss der Studie und die FDA-Einreichung liegen.
- Successful enrollment of 50% of patients in the ACCESS-PVI pivotal human clinical trial
- On track to complete enrollment and follow-up in Q4 2024
- 510(k) submission to FDA planned by the end of 2024
- Positive physician feedback on ease of use and quick set-up of LIBERTY® system
- Short learning curve reported by participating physician
- None.
Insights
The announcement of 50% enrollment completion in Microbot Medical's pivotal human clinical trial for the LIBERTY® Endovascular Robotic Surgical System is a significant milestone. This progress suggests the trial is proceeding as planned, which is important for potential FDA approval and subsequent commercialization.
The expected completion of enrollment in Q4 2024 and planned FDA submission by year-end indicate a well-defined timeline for bringing this innovative technology to market. The positive feedback from Dr. Rabkin regarding the system's ease of use and short learning curve is particularly encouraging, as it suggests potential for rapid adoption in clinical settings.
However, investors should note that while progress is positive, FDA approval is not guaranteed. The success of the 510(k) submission will depend on the final trial results and the FDA's assessment of the device's safety and efficacy.
Microbot Medical's progress in its clinical trial is a positive indicator for potential future revenue streams. The company's ability to stick to its timeline suggests effective operational management, which is important for investor confidence.
The endovascular robotics market is projected to grow significantly and Microbot's LIBERTY® system could capture a substantial share if approved. However, investors should consider that commercialization is still at least a year away, assuming FDA approval. The company will likely need to demonstrate a clear path to profitability and market penetration post-approval.
While the news is encouraging, it's important to note that Microbot is still in the pre-revenue stage. The company's financial health and cash runway to support the regulatory process and potential market launch will be critical factors to monitor. Investors should also be aware of potential dilution risks if additional funding is needed before commercialization.
The LIBERTY® Endovascular Robotic Surgical System represents a significant advancement in minimally invasive vascular procedures. Its potential to simplify complex interventions could lead to improved patient outcomes and reduced procedure times.
The system's reported ease of use and quick setup are particularly noteworthy. These factors can contribute to faster adoption rates and potentially lower training costs for healthcare facilities, which could be a strong selling point for Microbot Medical.
However, the endovascular robotics field is becoming increasingly competitive. Microbot will need to demonstrate clear clinical and economic advantages over existing systems and manual techniques to gain market share. The company's ability to differentiate LIBERTY® in terms of precision, efficiency and cost-effectiveness will be important for its commercial success post-approval.
Completion of enrollment expected in Q4 with FDA submission for commercialization anticipated by the end of 2024
BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of
ACCESS-PVI is a prospective, multi-center, single-arm, clinical trial designed to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions. The trial is expected to support the future 510(k) submission to the FDA and, when approved, subsequent commercialization.
“I have performed several procedures using LIBERTY® during the trial and I am continuing to enroll patients,” commented Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology) at Brigham and Women's Hospital in Boston. “I am pleased with the ease of use and quick set-up of the robot, requiring, in my experience, a very short learning curve.”
“We are excited by both the achievement of this milestone, and physician feedback. We remain on track to complete the trial and subsequent submission of the 510(k) to the FDA before year end,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer.
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, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, 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.
Investor Contact:
Michal Efraty
This press release was published by a CLEAR® Verified individual.
FAQ
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