FDA Approves Lumisight™ Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
The FDA approved Lumicell, Inc.’s New Drug Application (NDA) for its Lumisight™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™.
- Lumicell, Inc., is a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery.
- With 84% diagnostic accuracy, LumiSystem enables surgeons to scan the breast cavity postlumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries.
- The safety of the system was established using data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers across the U.S.
Source: Lumicell, Inc.
