Microbot Medical Accelerates Patient Enrollment of its Pivotal Human Clinical Trial; Expects to Complete the Trial Earlier Than Anticipated as 80% of Patients Have Completed Follow up
Microbot Medical Inc. (Nasdaq: MBOT) has announced an acceleration in patient enrollment for its ACCESS-PVI human clinical trial of the LIBERTY® Endovascular Robotic Surgical System. With 80% of patients having completed the follow-up period, the company expects to finish the trial earlier than anticipated. Microbot remains on track to file its 510(k) submission with the FDA by the end of 2024.
The company has successfully completed all biocompatibility tests required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. ACCESS-PVI is a prospective, multi-center, single-arm trial evaluating the performance and safety of LIBERTY® in peripheral vascular interventions. Microbot is also conducting additional bench testing, with results to be included in the 510(k) submission.
Microbot Medical Inc. (Nasdaq: MBOT) ha annunciato un'accelerazione nell'arruolamento dei pazienti per il suo trial clinico ACCESS-PVI sullLIBERTY® Sistema Chirurgico Robotico Endovascolare. Con l'80% dei pazienti che ha completato il periodo di follow-up, l'azienda prevede di concludere il trial prima del previsto. Microbot è sulla buona strada per presentare la sua richiesta 510(k) alla FDA entro la fine del 2024.
L'azienda ha completato con successo tutti i test di biocompatibilità richiesti dalla sua richiesta di Esenzione Dispositivo Investigativo (IDE) e ha ricevuto l'approvazione completa per lo studio IDE dalla FDA. ACCESS-PVI è un trial prospettico, multicentrico e a braccio unico che valuta le prestazioni e la sicurezza di LIBERTY® nelle interventi vascolari periferici. Microbot sta anche conducendo ulteriori test di laboratorio, i cui risultati saranno inclusi nella richiesta 510(k).
Microbot Medical Inc. (Nasdaq: MBOT) ha anunciado una aceleración en la inscripción de pacientes para su ensayo clínico ACCESS-PVI sobre el Sistema Quirúrgico Robótico Endovascular LIBERTY®. Con el 80% de los pacientes completando el período de seguimiento, se espera que la empresa finalice el ensayo antes de lo previsto. Microbot sigue en camino de presentar su solicitud 510(k) a la FDA a finales de 2024.
La empresa ha completado con éxito todas las pruebas de biocompatibilidad requeridas por su solicitud de Exención de Dispositivo Investigacional (IDE) y ha recibido la aprobación total para el estudio IDE por parte de la FDA. ACCESS-PVI es un ensayo prospectivo, multicéntrico y de brazo único que evalúa el rendimiento y la seguridad de LIBERTY® en intervenciones vasculares periféricas. Microbot también está realizando pruebas adicionales de banco, cuyos resultados se incluirán en la solicitud 510(k).
마이크로봇 메디컬 Inc. (Nasdaq: MBOT)는 LIBERTY® 혈관 로봇 외과 시스템에 대한 ACCESS-PVI 인체 임상 시험에서 환자 등록이 가속화되었다고 발표했습니다. 환자의 80%가 추적 관찰 기간을 완료한 가운데, 회사는 시험을 예상보다 일찍 마칠 것으로 보입니다. 마이크로봇은 2024년 말까지 FDA에 510(k) 신청서를 제출할 예정입니다.
회사는 조사 기기 면제(IDE) 신청서에 필요한 모든 생체 적합성 테스트를 성공적으로 완료했으며 FDA로부터 IDE 연구에 대한 전체 승인을 받았습니다. ACCESS-PVI는 말초 혈관 개입에서 LIBERTY®의 성능과 안전성을 평가하는 전향적 다기관 단일 그룹 시험입니다. 마이크로봇은 또한 추가적인 벤치 테스트를 수행 중이며, 그 결과는 510(k) 신청서에 포함될 것입니다.
Microbot Medical Inc. (Nasdaq: MBOT) a annoncé une accélération de l'inscription des patients pour son essai clinique ACCESS-PVI portant sur le Système Chirurgical Robotique Endovasculaire LIBERTY®. Avec 80 % des patients ayant terminé la période de suivi, l'entreprise prévoit de terminer l'essai plus tôt que prévu. Microbot est également sur le point de soumettre son dossier 510(k) à la FDA d'ici la fin de 2024.
L'entreprise a réussi à compléter tous les tests de biocompatibilité requis par sa demande d'exemption de dispositif d'investigation (IDE) et a reçu l'approbation complète de l'étude IDE par la FDA. ACCESS-PVI est un essai prospectif, multicentrique et en bras unique évaluant les performances et la sécurité de LIBERTY® lors d'interventions vasculaires périphériques. Microbot effectue également des tests supplémentaires en laboratoire, dont les résultats seront inclus dans le dossier 510(k).
Microbot Medical Inc. (Nasdaq: MBOT) hat eine Beschleunigung der Patientenrekrutierung für die ACCESS-PVI-Human-Clinical-Studie des LIBERTY® Endovaskulären Robotischen Chirurgischen Systems angekündigt. Da 80 % der Patienten den Nachbeobachtungszeitraum abgeschlossen haben, erwartet das Unternehmen, die Studie früher als geplant abzuschließen. Microbot ist auf Kurs, den 510(k) Antrag bis Ende 2024 bei der FDA einzureichen.
Das Unternehmen hat erfolgreich alle Biokompatibilitätstests abgeschlossen, die für seinen Antrag auf Untersuchungseinrichtungsausnahme (IDE) erforderlich sind, und hat die volle Genehmigung für die IDE-Studie von der FDA erhalten. ACCESS-PVI ist eine prospektive, multizentrische, einarmige Studie zur Bewertung der Leistung und Sicherheit von LIBERTY® bei peripheren vaskulären Eingriffen. Microbot führt auch zusätzliche Banktests durch, deren Ergebnisse in den 510(k)-Antrag aufgenommen werden sollen.
- Accelerated patient enrollment in ACCESS-PVI clinical trial
- 80% of patients have completed follow-up period
- On track for FDA 510(k) submission by end of 2024
- Completed all IDE required tests
- Received final IDE approval from FDA for ACCESS-PVI study
- None.
Insights
The accelerated patient enrollment in Microbot Medical's ACCESS-PVI clinical trial for the LIBERTY® Endovascular Robotic Surgical System is a significant development. With 80% of patients having completed follow-up, the trial is progressing faster than anticipated, potentially leading to earlier completion. This acceleration could have several positive implications:
- Faster path to market: The company remains on track for FDA 510(k) submission by end of 2024, which could lead to earlier commercialization.
- Cost efficiency: Accelerated trials often result in lower overall costs.
- Competitive advantage: Earlier market entry could provide a first-mover advantage in the endovascular robotics space.
The completion of all IDE-required biocompatibility tests and receipt of final IDE approval from the FDA further strengthens the company's regulatory position. These developments, combined with the ongoing bench testing, indicate a comprehensive approach to ensuring the LIBERTY® system's safety and efficacy. For investors, these advancements suggest a reduced regulatory risk and a potentially smoother path to market approval.
From a financial perspective, Microbot Medical's accelerated clinical trial progress is a positive indicator for the company's future prospects. Key financial implications include:
- Potential for earlier revenue generation: If the 510(k) submission and approval process proceeds as planned, the company could begin commercialization sooner than expected.
- Reduced cash burn: Faster trial completion could lead to lower R&D expenses in the near term.
- Increased investor confidence: Positive clinical progress often translates to improved market sentiment, potentially supporting the stock price.
However, it's important to note that with a market cap of only
Confirms the Company on Track for FDA 510(k) Submission by end of 2024
Completes All IDE required Tests and Receives Final IDE Approval from the FDA for the ACCESS-PVI Study
BRAINTREE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it is currently experiencing an acceleration of patient enrollment for ACCESS-PVI human clinical trial for LIBERTY®. As a result of the increased rate of patient enrollment,
“The trial is progressing well, and I am pleased with the level of enthusiasm at all three clinical sites which has resulted in the acceleration of patient enrollment. This gives us additional confidence that we can complete the trial and submit for FDA clearance by the end of 2024,” commented Harel Gadot, Chairman, CEO and President.
“I applaud the entire team at Microbot Medical and the physicians participating in the study as we near the finish line. I believe their continued commitment will allow us to maintain the positive momentum over the next several weeks and allow us to achieve our near-term milestones, including the completion of the study,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical.
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 also announced that is has successfully completed all biocompatibility tests, as required by its Investigational Device Exemption (IDE) application and received full approval for the IDE study from the FDA. The Company had previously disclosed that it had received approval from the FDA to commence its clinical trial, and in parallel complete biocompatibility testing. In parallel with the clinical trial, the Company is performing additional customary bench testing, and these final results will be included in the Company’s 510(k) submission.
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
FAQ
What is the current status of Microbot Medical's ACCESS-PVI clinical trial for LIBERTY®?
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