On April 18, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported a Premarket Approval (PMA) application for its Lumicell Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Lumicell Diagnostics, APR 18, 2023, View Source [SID1234630292]).
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The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity. The New Drug Application (NDA) for LUMISIGHT was submitted to the FDA in March 2023.
"The PMA submission for our Lumicell Direct Visualization System is the culmination of years of hard work from all of our clinical trial investigators and the Lumicell team," said Kevin Hershberger, president and chief executive officer of Lumicell. "This major milestone brings us one step closer to revolutionizing the way breast cancer surgery is performed and delivering meaningful clinical benefits to surgeons and patients."
The Lumicell DVS submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.
"The current standard of care focuses on tissue that has already been removed instead of inside the patient where it matters," said Irene Wapnir, MD, professor of surgery at Stanford University School of Medicine and investigator of the INSITE clinical trial. "A device like the Lumicell DVS which can look inside the breast cavity for residual cancer could be a crucial tool to help improve patient outcomes."
About the Lumicell Direct Visualization System
The investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.
The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.