NAMSphere: AI-Automated NAMs (New Approach Methodologies) Platform for Preclinical Testing
NAMSphere is the world's first automated AI platform built on New Approach Methodologies (NAMs), the human-relevant methods replacing animal testing in immuno-oncology drug development. It co-cultures 3D tumor models with immune cells to reproduce the tumor microenvironment, then combines high-throughput screening (HTS) robotics with medical-specialized AI (MedSAM2-based) to run the entire immuno-oncology efficacy screening workflow end-to-end. Biotech ventures and non-clinical CROs lack immune co-culture specialists, so they screen on 2D models that cannot reproduce 3D immune-tumor interaction before entering animal studies, and the FDA reports that over 90% of drugs clearing animal studies never reach approval. NAMSphere automates the process into a single unmanned workflow, compressing days of analysis into under 10 minutes and delivering clinically predictive NAMs data. Within one year of founding, DAEDANBIO filed 7 patents, reached 0.9437 Dice segmentation accuracy, and won multiple national R&D programs. NAMSphere removes the risk of entering the clinic blind.