OPP002 📄 Overview Develop a robotic platform for ultra-precise, localized delivery of chemotherapeutic agents directly into and around glioblastoma tumors. The system would integrate real-time MRI or intraoperative ultrasound imaging with AI-driven tumor margin detection to guide a micro-catheter or needle, ensuring maximum drug concentration at the tumor site while minimizing exposure to healthy brain tissue. This could improve survival and reduce systemic toxicity compared to conventional chemotherapy. Key technologies: 👤 Target users: 👍 Benefits Enhanced local tumor control and reduced recurrence rates • Significantly lower systemic toxicity of chemotherapy • Improved patient quality of life during treatment • Extension of progression-free survival and overall survival Use bullets or new lines. 👎 Challenges Accuracy of AI-driven tumor margin detection in heterogeneous tissue • Managing drug diffusion patterns post-injection • Risk of hemorrhage or infection during procedure • Training and adoption by neurosurgeons • Regulatory approval for a combined robotic/drug delivery platform 📋 Regulatory & Validation Requires approval for both the robotic surgical system (Class II/III medical device) and the drug delivery method (IND/NDA for drug-device combination) • Usability studies for surgical workflow (IEC 62366) • Pre-clinical data on drug distribution and local toxicity • Clinical trials demonstrating improved survival endpoints