Diagnostics & Devices:
FluoroMap™ — Binary-Fluorescence, AI-Guided Cancer Surgery
Baran D. Sumer, M.D.
- Professor & Chief, Head & Neck Oncology, UT Southwestern
Jinming (J.) Gao, Ph.D.
- Professor of Biomedical Engineering & Oncology, UT Southwestern
Cancer surgeons often rely on white-light video that can be fooled by blood and inflammation, leading to missed tumor or unnecessary removal of healthy tissue. Pegsitacianine is a pH-activated nanoparticle that turns its fluorescence fully ON only in acidic tumor tissue, giving a clean, digital signal that standard ICG cameras (including da Vinci) can already see. FluoroMap will fuse that binary fluorescence with operating-room video to train AI that suppresses false positives and pinpoints tumor in real time, starting in head-and-neck surgery and extending to peritoneal metastases. The dataset from the ILLUMINATE Phase II trial plus existing GMP drug supply (~200 patients) gives us a fast, de-risked path to a planning tool first, then an intra-op overlay. The commercialization wedge is software (SaMD) that rides today’s OR hardware, with optional continuation of the imaging agent to sustain clinical momentum and moat.
