Microbot Medical Accelerates Clinical Trial Progress Significantly
Microbot Medical Expands Clinical Trial Efforts
Microbot Medical Inc. (NASDAQ: MBOT), known for its groundbreaking LIBERTY Endovascular Robotic Surgical System, has made significant strides in its ACCESS-PVI human clinical trial. The company has reported an impressive acceleration in patient enrollment, with 80% of participants completing their follow-up assessments. This increased recruitment pace not only signifies the trial's success but also positions the company to potentially complete the study earlier than previously forecasted.
Triumphant Progress in Patient Enrollment
The excitement surrounding the LIBERTY system has created a surge in patient interest across all participating clinical sites. Harel Gadot, the Chairman, CEO, and President of Microbot Medical, expressed his satisfaction with the rapid pace of enrollment, emphasizing the enthusiasm from both patients and physicians involved in the trial.
Trial Details and Expectations
The CHARACTERISTICS of the ACCESS-PVI trial are notable. It is a prospective, multi-center, single-arm study aimed at evaluating the safety and performance of the LIBERTY system specifically designed for Peripheral Vascular Interventions. This trial is a crucial step toward securing the 510(k) submission to the U.S. Food and Drug Administration (FDA).
Meeting Rigor of Regulatory Standards
In tandem with the growing patient enrollment, Microbot Medical has successfully completed all biocompatibility tests required for its Investigational Device Exemption (IDE) application. The company has received final approval from the FDA, allowing it to progress seamlessly. These accomplishments further strengthen its pathway toward regulatory approval.
Future Projections for Product Launch
Microbot Medical is on track for a 510(k) submission to the FDA by the end of 2024. This timeline aligns perfectly with the company's ongoing developmental milestones, including the completion of customary bench testing, which is expected to accompany its submission documentation.
About Microbot Medical
As a clinical-stage medical device company, Microbot Medical Inc. (NASDAQ: MBOT) is dedicated to advancing micro-robotic technologies, aiming to enhance clinical outcomes while ensuring accessibility to cutting-edge healthcare solutions. The LIBERTY Endovascular Robotic Surgical System specifically aims to redefine endovascular surgical procedures by minimizing the reliance on traditional, bulky equipment and reducing exposure to radiation.
Innovative Solutions for Healthcare Patients
The LIBERTY system not only enhances the procedural experience for medical professionals but also aims to improve patient outcomes significantly. By facilitating remote surgical operations, it seeks to democratize access to Vascular Interventional procedures, potentially transforming how surgeries are conducted in the future.
Frequently Asked Questions
What is the main focus of the ACCESS-PVI clinical trial?
The ACCESS-PVI clinical trial is focused on evaluating the performance and safety of Microbot Medical's LIBERTY Endovascular Robotic Surgical System for Peripheral Vascular Interventions.
How has patient enrollment progressed in the trial?
Patient enrollment in the trial has accelerated, with 80% completion of follow-up assessments, indicating strong engagement from both patients and clinical sites.
What regulatory actions is Microbot Medical pursuing?
Microbot Medical is on track to submit its 510(k) application to the FDA by the end of 2024, following the successful completion of required trials and testing.
What is the significance of the LIBERTY system?
The LIBERTY Endovascular Robotic Surgical System aims to improve surgical procedures by reducing equipment size and cost while enhancing safety and efficacy for patients.
Who can I contact for investor relations inquiries?
For investor relations inquiries, you can contact Michal Efraty via email at IR@microbotmedical.com.
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