Lumicell Reports the Submission of Premarket Approval Application to the US FDA for Lumicell Direct Visualization System
Shots:
- The company has submitted the premarket approval application to the US FDA for Lumicell DVS to allow real assessment of the breast cavity for residual breast cancer detection & removal
- The submission was based on results from ~700 patients with breast cancer across 5 clinical trials at top academic & regional community cancer centers. The safety and efficacy of the Lumicell DVS have been examined in the P-III trial (INSITE) in 406 patients at 14 sites & results will be presented at ASBrS 2023
Lumisight received the FTD from the US FDA & Lumicell DVS received BTD to identify residual cancer during the initial lumpectomy. Lumisight (pegulicianine) is intended for use with Lumicell DVS for fluorescence imaging of the lumpectomy cavity
Ref: BusinessWire | Image: Lumicell
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