Lumicell's Lumisight, LumiSytem get FDA nods

Lumicell's Lumisight (pegulicianine) optical imaging agent has been approved by a new drug application (NDA) by the U.S. Food and Drug Administration (FDA).

The FDA has also granted premarket approval for the company's LumiSystem, Lumicell's direct visualization system. Both Lumisight and LumiSystem previously received FDA Fast Track and Breakthrough Device designations.

LumiSystem allows surgeons to scan the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer that may have otherwise been missed, potentially sparing some patients from second surgeries. Its combination with Lumisight is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following lumpectomy surgery.

Lumicell said that the safety of LumiSystem was established using data from more than 700 breast cancer patients across five clinical studies at academic and regional community cancer centers across the U.S.

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