Lumicell is a medical technology company developing fluorescence-guided imaging solutions designed to support cancer surgery. The company has developed intraoperative imaging technology that helps surgeons identify residual cancerous tissue in real time following an initial lumpectomy, supporting more complete tumor removal while preserving healthy tissue. With an initial focus on breast cancer surgery, Lumicell is addressing a major challenge in surgical oncology: identifying remaining tumor tissue that may not be visible through conventional surgical techniques. The company’s technology provides surgeons with additional visualization during procedures, enabling access to real-time information that can assist clinical decision-making during cancer resection.

Lumicell’s work is built around the development of imaging technologies that connect molecular detection with surgical visualization. By integrating specialized imaging agents with advanced detection systems, the company is creating tools designed to help clinicians evaluate tissue during procedures and support precision in cancer surgery. Through its drug-device technology platform, Lumicell is expanding the role of fluorescence-guided imaging in surgical oncology while evaluating additional applications across multiple cancer indications.

LumiSystem™

Lumicell’s flagship LumiSystem™ platform integrates the LUMISIGHT™ Optical Imaging Agent with the Lumicell™ Direct Visualization System (DVS) to provide fluorescence-guided visualization during surgical procedures. LUMISIGHT™ is designed to remain optically inactive until activated by enzymes associated with tumor and tumor-associated cells. Once activated, the imaging agent generates a fluorescent signal that helps highlight areas within the surgical cavity that may contain residual cancerous tissue following tumor removal.

The Lumicell™ DVS captures and displays fluorescence during surgery, providing surgeons with additional visual information beyond standard surgical observation. The platform is designed to assist clinicians in evaluating tissue after initial resection and identifying areas that may require further assessment during the procedure. Initially developed for breast cancer surgery, LumiSystem™ has also been evaluated across multiple solid tumor applications, including gastrointestinal cancers, peritoneal metastases, brain cancer, sarcoma, and prostate cancer.

The Science Behind Lumicell’s Imaging Technology

Lumicell’s technology is based on fluorescence-guided imaging, a field that uses specialized agents and detection systems to visualize biological structures during medical procedures. The company’s LUMISIGHT™ Optical Imaging Agent is designed to interact with enzymes found at higher levels in and around tumor-associated cells compared with normal tissue. This mechanism allows the agent to generate a fluorescent signal intended to help surgeons locate areas of concern during cancer procedures.

The Lumicell™ Direct Visualization System has been evaluated in clinical studies involving more than 800 patients across seven cancer types at 18 leading medical centers in the United States. Research has examined applications in breast cancer, gastrointestinal cancers, peritoneal metastases, sarcoma, brain cancer, and prostate cancer. Lumicell’s breast cancer program included the INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) pivotal trial, which evaluated the use of the Lumicell DVS during breast-conserving surgery. Results from this study supported the company’s Premarket Approval (PMA) and New Drug Application (NDA) submissions to the U.S. Food and Drug Administration.

FDA Approval and Commercial Milestone

Lumicell achieved a significant regulatory milestone with FDA approval of its LumiSystem™ platform for use in breast cancer surgery. The approval introduced a drug-device technology designed to provide surgeons with additional visualization during lumpectomy procedures by identifying fluorescent signals associated with residual breast cancer tissue following tumor removal. The system includes the LUMISIGHT™ Optical Imaging Agent and the Lumicell™ Direct Visualization System, creating a technology platform designed for intraoperative assessment.

Following regulatory authorization, LumiSystem™ entered commercial use as a fluorescence-guided imaging technology for breast-conserving surgery. The platform represents Lumicell’s first commercial application and reflects the company’s work in developing surgical tools that provide additional information during cancer procedures. Lumicell continues to evaluate the potential use of its imaging platform across additional oncology applications through clinical research and development programs.

Expanding Applications Across Oncology

Lumicell is evaluating the potential of its fluorescence-guided imaging platform across a range of solid tumor applications. Clinical investigations have included gastrointestinal cancers, peritoneal metastases, brain cancer, sarcoma, and prostate cancer, with research programs examining how fluorescence-based visualization can support surgeons during cancer procedures.

The Lumicell DVS has received Breakthrough Device Designation for breast cancer, gastrointestinal cancers, and all solid tumors. LUMISIGHT™ has received Fast Track Designation for breast cancer from the U.S. Food and Drug Administration. Through ongoing clinical studies and technology development, Lumicell is working to expand the applications of fluorescence-guided imaging within surgical oncology and provide clinicians with additional tools for tumor visualization.

JORGE FERRER, PH.D. | CHIEF SCIENTIFIC OFFICER

Dr. Jorge Ferrer is the Chief Scientific Officer of Lumicell and a co-inventor of the company’s drug-device technology. He played an important role in translating research innovations from the laboratory of MIT Professor Moungi Bawendi, the 2023 Nobel Laureate in Chemistry, into the technology that led to the founding of Lumicell. Dr. Ferrer has guided Lumicell’s technology development from early research and development through clinical studies, overseeing the company’s Premarket Approval (PMA) and New Drug Application (NDA) submissions that resulted in FDA approval of its flagship breast cancer product.

As Chief Scientific Officer, Dr. Ferrer leads technology development, supports research programs focused on additional cancer applications, and explores future uses of Lumicell’s imaging platform beyond oncology. He holds a doctorate in biological engineering and a master’s degree in mechanical engineering from the Massachusetts Institute of Technology, along with a bachelor’s degree in mechanical engineering from the University of Puerto Rico Mayagüez. His background in engineering, biomedical research, and clinical technology development has contributed to Lumicell’s work in fluorescence-guided surgical imaging.