Lumicell Reports the NDA Submission of Lumisight Optical Imaging Agent to the US FDA for the Detection and Removal of Intraoperative Breast Cancer
Shots:
- The US FDA has submitted the NDA for Lumisight, an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for more complete resection as part of the investigational Lumicell direct visualization system
- The submission was based on results from ~700 patients with breast cancer across 5 clinical trials at top academic and regional community cancer centers. The safety and efficacy of the Lumicell DVS system have been examined in the P-III trial (INSITE) in 406 patients at 14 sites & results will be presented at ASBrS 2023 & published in JAMA Surgery
- The company will submit the PMA for the Lumicell DVS in Q2’23. Lumisight received the FTD from the US FDA and Lumicell DVS received BTD
Ref: Businesswire | Image: Lumicell
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