REMINDER: Microbot Medical Announces Data from the Company’s ACCESS-PVI trial will be Presented via Podium Presentation at Society of Interventional Radiology Annual Meeting
Microbot Medical (Nasdaq: MBOT) announces that data from its ACCESS-PVI trial for the LIBERTY® Endovascular Robotic System will be presented at the Society of Interventional Radiology Annual Meeting. The presentation will be delivered by Dr. Francois Cornelis from Memorial Sloan Kettering Cancer Center on April 2, 11:33am CT.
The ACCESS-PVI trial is a prospective, multicenter, single-arm study evaluating the performance and safety of LIBERTY® in peripheral vascular interventions. The company's executive and clinical teams are conducting meetings with SIR attendees. Importantly, Microbot Medical reaffirms its expectation for the FDA's decision regarding LIBERTY®'s 510(K) clearance during the current second quarter.
Microbot Medical (Nasdaq: MBOT) annuncia che i dati del suo trial ACCESS-PVI per il sistema robotico endovascolare LIBERTY® saranno presentati al Congresso Annuale della Society of Interventional Radiology. La presentazione sarà tenuta dal Dr. Francois Cornelis del Memorial Sloan Kettering Cancer Center il 2 aprile alle 11:33 CT.
Il trial ACCESS-PVI è uno studio prospettico, multicentrico e a braccio singolo che valuta le performance e la sicurezza di LIBERTY® nelle interventi vascolari periferici. I team esecutivo e clinico dell'azienda stanno conducendo incontri con i partecipanti al SIR. È importante sottolineare che Microbot Medical ribadisce le proprie aspettative riguardo alla decisione della FDA sulla clearance 510(K) di LIBERTY® durante il corrente secondo trimestre.
Microbot Medical (Nasdaq: MBOT) anuncia que los datos de su ensayo ACCESS-PVI para el sistema robótico endovascular LIBERTY® serán presentados en la Reunión Anual de la Sociedad de Radiología Intervencionista. La presentación será realizada por el Dr. Francois Cornelis del Memorial Sloan Kettering Cancer Center el 2 de abril a las 11:33 am CT.
El ensayo ACCESS-PVI es un estudio prospectivo, multicéntrico y de un solo brazo que evalúa el rendimiento y la seguridad de LIBERTY® en intervenciones vasculares periféricas. Los equipos ejecutivo y clínico de la empresa están llevando a cabo reuniones con los asistentes al SIR. Es importante destacar que Microbot Medical reafirma su expectativa sobre la decisión de la FDA respecto a la autorización 510(K) de LIBERTY® durante el actual segundo trimestre.
마이크로봇 메디컬 (Nasdaq: MBOT)은 LIBERTY® 혈관 내 로봇 시스템에 대한 ACCESS-PVI 시험의 데이터가 중재 방사선학회 연례 회의에서 발표될 것이라고 발표했습니다. 발표는 메모리얼 슬로안 케터링 암 센터의 프랑수아 코르넬리스 박사가 4월 2일 오전 11:33 CT에 진행합니다.
ACCESS-PVI 시험은 말초 혈관 중재에서 LIBERTY®의 성능과 안전성을 평가하는 전향적 다기관 단일군 연구입니다. 회사의 경영 및 임상 팀은 SIR 참석자들과 회의를 진행하고 있습니다. 중요한 것은 마이크로봇 메디컬이 현재 2분기 동안 LIBERTY®의 510(K) 승인에 대한 FDA의 결정을 기대하고 있음을 재확인하고 있다는 점입니다.
Microbot Medical (Nasdaq: MBOT) annonce que les données de son essai ACCESS-PVI pour le système robotique endovasculaire LIBERTY® seront présentées lors de la réunion annuelle de la Society of Interventional Radiology. La présentation sera faite par le Dr. Francois Cornelis du Memorial Sloan Kettering Cancer Center le 2 avril à 11h33 CT.
L'essai ACCESS-PVI est une étude prospective, multicentrique et à bras unique évaluant la performance et la sécurité de LIBERTY® dans les interventions vasculaires périphériques. Les équipes exécutives et cliniques de l'entreprise mènent des réunions avec les participants au SIR. Il est important de noter que Microbot Medical réaffirme ses attentes concernant la décision de la FDA sur l'autorisation 510(K) de LIBERTY® au cours du deuxième trimestre actuel.
Microbot Medical (Nasdaq: MBOT) gibt bekannt, dass Daten aus der ACCESS-PVI-Studie für das LIBERTY® endovaskuläre Robotersystem auf dem Jahresmeeting der Society of Interventional Radiology präsentiert werden. Die Präsentation wird von Dr. Francois Cornelis vom Memorial Sloan Kettering Cancer Center am 2. April um 11:33 Uhr CT gehalten.
Die ACCESS-PVI-Studie ist eine prospektive, multizentrische, einarmige Studie zur Bewertung der Leistung und Sicherheit von LIBERTY® bei peripheren vaskulären Interventionen. Die Geschäfts- und Klinischen Teams des Unternehmens führen Meetings mit den Teilnehmern der SIR durch. Wichtig ist, dass Microbot Medical seine Erwartungen an die Entscheidung der FDA zur 510(K)-Freigabe von LIBERTY® im aktuellen zweiten Quartal bekräftigt.
- Pending FDA 510(K) clearance decision for LIBERTY® expected in Q2 2025
- First podium presentation of ACCESS-PVI trial data at major medical conference
- None.
Company Reaffirms Expected Timing of FDA Decision With Respect to 510(K) Clearance of LIBERTY® During the Current Second Quarter
BRAINTREE, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, is providing this reminder that data from the Company’s ACCESS-PVI trial will be presented by Francois Cornelis, MD, PhD, FCIRSE, Memorial Sloan Kettering Cancer Center, Department of Radiology. This is the first time data from the study will be presented via a podium presentation, to take place on Wednesday, April 2, 11:33am CT.
ACCESS-PVI trial, a prospective, multicenter, single-arm trial evaluating the performance and safety of LIBERTY® in patients undergoing peripheral vascular interventions.
In conjunction with the data presentation, members of the Company’s executive and clinical teams have been meeting with SIR attendees. The Company reaffirms that it expects the FDA’s decision with respect to 510(K) clearance of LIBERTY® during the current second quarter.
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 System, uncertainty in the results of regulatory pathways and regulatory approvals, including whether the FDA will timely grant 510(k) clearance to commercially market the LIBERTY® Endovascular Robotic System in the United States if at all, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA, 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
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