Key Studies Examined the Benefits of Intraoperative Imaging Using Investigational Agent LUMISIGHT™ in Combination with Lumicell™ Direct Visualization System (DVS)
NEWTON, Mass., March 25, 2024—Lumicell Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer detection during surgery, highlights presentations from clinical studies examining the use of investigational LUMISIGHT™ (pegulicianine) in combination with Lumicell™ Direct Visualization System (DVS) at the Society of Surgical Oncology Annual Meeting in Atlanta, Georgia, March 20-23, 2024.
The posters presented at SSO 2024 can be found here and are listed below:
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- Kelly K. Hunt, M.D., Department of Breast Surgery at MD Anderson Cancer Center, shared patient satisfaction via BREAST-Q survey from Patient Reported Outcomes from a Multi-Site, Prospective Pivotal study Evaluating Pegulicianine Fluorescence-Guided surgery (pFGS) for Breast Cancer Lumpectomy Procedures using the Lumicell™ Direct Visualization System (DVS).
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- Carlos HF Chan, M.D., PhD., Associate Professor, Department of Surgery, University of Iowa Hospitals and Clinics, shared interim results from Feasibility of the Pegulicianine Fluorescence Guided Surgery for Detection of Peritoneal Surface Malignancies.
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- Irene Wapnir, M.D., Professor of Surgery, Stanford University Medical Center shared results from a randomized, two-arm study, Positive Pegulicianine Fluorescence in the Lumpectomy Cavity Correlates with Tumor Distance to Margins.
Additionally, Barbara Smith, M.D., Ph.D., Director of the Breast Program at Massachusetts General Hospital, delivered a Breast Cancer Hub Zone talk titled, Seeing Cancer in a Different Light: Human Trials of Intraoperative Molecular Imaging in Surgical Oncology which featured results from the INSITE study.
“It’s so energizing to see such a diversity of surgeons across different specialties come together to advance the collective field of surgical oncology,” said Jorge Ferrer, M.D., PhD, Chief Scientific Officer, Lumicell. “Our goal with LUMISIGHT and Lumicell DVS is to provide surgeons with a powerful tool that will detect cancer tissue in real-time for removal during surgery, to achieve more complete resections and decrease the emotional and physical toll for patients.”
Lumicell submitted a new drug application (NDA) for LUMISIGHT for use in patients with breast cancer undergoing a lumpectomy in 2023 along with a premarket approval (PMA) application for Lumicell™ DVS. Most recently, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted in support of the benefit-risk profile of LUMISIGHT™ (pegulicianine) during its March 5, 2024 meeting. The FDA is expected to make a decision on Lumicell’s NDA and PMA in the near future.
About LUMISIGHT™ and Lumicell™ Direct Visualization System (DVS)
LUMISIGHT™, an optical imaging agent, is used in combination with Lumicell™ DVS, a fluorescence-guided imaging system, and is designed for real-time fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery, also known as breast conserving surgery. LUMISIGHT™ and Lumicell™ DVS are for investigational use only and are not commercially available
About Lumicell Inc.
Lumicell is a privately held company focused on improving surgical outcomes and reducing healthcare costs by utilizing its innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may otherwise be left behind. The company’s lead products in development are LUMISIGHT and Lumicell DVS which are designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.lumicell.com and follow the company on Facebook, X, and LinkedIn.
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