Lumicell, Inc. today announced FDA submission of the LUMISIGHT™ Optical Imaging Agent New Drug Application. LUMISIGHT is intended for use with their Lumicell™ Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue following removal of the primary specimen during the initial lumpectomy.
Data has shown that at least 20% of women undergoing breast conserving surgery require a second surgery due to incomplete tumor removal, and 6-10% end up experiencing a local recurrence of breast cancer. Technology like the Lumicell DVS can aid in detecting and removing residual cancer during the initial surgery, which has the potential to support improved outcomes.
The LUMISIGHT NDA submission is supported by data from 700+ breast cancer patients across five clinical studies, and results from its INSITE pivotal trial will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. LUMISIGHT was previously granted Fast Track designation by the FDA. Following its LUMISIGHT NDA submission, the company plans to submit the PMA for the Lumicell DVS in the second quarter of this year.
The Lumicell DVS is a combination product which includes the LUMISIGHT Optical Imaging Agent, a hand-held imaging probe designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer and enable a more complete resection.
By way of introduction, Lumicell is a Massachusetts-based private company reimagining the practice of cancer surgery by utilizing innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may have otherwise been left behind. The first indication the company is pursuing is for breast cancer.
The Lumicell DVS is designed by engineers and scientists from MIT, in close partnership with leading breast cancer surgeons, to fit seamlessly within the existing surgical workflow.