Considering these factors, what would you percentage-wise give FDA approval likelihood for in-bots Liberty in the vascular system?
7/25/2025 11:13am
Considering the factors discussed, I would estimate the percentage likelihood of FDA approval for Microbot Medical's LIBERTY Endovascular Robotic System in the vascular system to be between 60% and 80%. Here's a breakdown of the supportive evidence:
1. **Company Progress and Hires**: MBOT's strategic hires, such as Christina Bailey and Michael Lytle, indicate a strong commitment to commercialization and a belief in the product's potential.
2. **Market Readiness**: The company's investment in commercial infrastructure, ISO 13485 certification, and engagement with strategic partners suggest a well-laid plan for distribution and market penetration.
3. **Clinical Trial Results**: The successful completion of the ACCESS-PVI pivotal trial with 100% technical success and a 92% reduction in clinician radiation exposure support the system's efficacy and safety profile.
4. **FDA Engagement**: Productive FDA interactions and the adjustment of the review timeline to Q3 2025 indicate a positive regulatory trajectory.
These factors contribute to an overall positive outlook for FDA approval. However, it's important to note that regulatory processes can be unpredictable, and there are still uncertainties involved. Therefore, while the likelihood appears high, it is not guaranteed.