OPP001 📄 Overview Develop a minimally invasive, implantable micro-pump system capable of delivering disease-modifying agents (e.g., gene therapies, growth factors) directly to specific brain regions. AI algorithms, integrated with intracranial biosensors (e.g., for neurotransmitter levels, inflammation markers) and external wearables, continuously monitor patient state and adapt drug dosage in real-time, optimizing therapeutic effect and minimizing side effects for conditions like Parkinson's or Alzheimer's. Key technologies: 👤 Target users: 👍 Benefits Significantly slow or halt disease progression • Reduce systemic side effects of high-dose therapies • Personalize treatment based on individual brain dynamics • Improve patient quality of life and functional independence Use bullets or new lines. 👎 Challenges Long-term biocompatibility and stability of implants • Precision and accuracy of intracranial sensor readings • Robustness and safety of AI-driven dosing algorithms • Surgical risks associated with implantation • Battery life and maintenance of implanted devices 📋 Regulatory & Validation Requires comprehensive biocompatibility data (ISO 10993) • Extensive software validation for AI/ML dosing algorithms (IEC 62304, IMDRF SaMD guidance) • Long-term clinical trials for safety and efficacy endpoints (e.g., motor scores, cognitive assessments) • Clear risk-benefit analysis for invasive procedure