Waltham, Massachusetts, U.S., September 15, 2026
Lumicell, Inc. is expanding the commercial use of LumiSystem®, its fluorescence-guided imaging platform designed to help surgeons detect residual cancer during breast-conserving surgery. The company highlighted growing adoption of the technology in the U.S. breast lumpectomy market, including implementation at a leading U.S. cancer center. LumiSystem combines LUMISIGHT® (pegulicianine), an optical imaging agent, with the Lumicell Direct Visualization System (DVS) to provide real-time fluorescence imaging of the lumpectomy cavity following removal of the primary tumor. The technology is designed to help surgeons identify areas of suspected residual cancer during the initial operation, potentially allowing additional tissue to be removed before the procedure is completed.
Real-Time Imaging Supports Breast-Conserving Surgery
A central feature of LumiSystem is its ability to evaluate the lumpectomy cavity while surgery is still underway. Conventional pathology-based assessment generally evaluates removed tissue after excision, whereas LumiSystem is designed to interrogate the cavity in situ and provide fluorescence-based information about areas that may contain residual cancer. This capability is intended to give surgeons additional information during the index procedure rather than relying solely on postoperative assessment. Lumicell said the technology is particularly relevant as breast cancer treatment becomes increasingly personalized and some patients undergo more de-escalated treatment approaches. In this setting, achieving complete removal of the targeted cancer during the first operation can be an important consideration. Real-time visualization may provide surgeons with another source of information when determining whether additional tissue should be removed during lumpectomy. The company emphasized that LumiSystem is an adjunct to standard surgical and pathology procedures, rather than a replacement for established clinical care.
Commercial Expansion Extends Clinical Adoption
Lumicell’s latest announcement reflects the continued commercial expansion of LumiSystem across U.S. breast cancer centers. The company said implementation at the nation’s leading cancer center represents an important milestone in expanding access to the technology and increasing awareness of fluorescence-guided cancer detection. LumiSystem entered U.S. commercial use in 2025 following FDA approval of its component products. The system combines the optical imaging agent LUMISIGHT with the Lumicell DVS fluorescence imaging device. During surgery, the imaging agent can help highlight suspected cancerous tissue, while the imaging device enables surgeons to visualize fluorescence within the resection cavity. The approach is intended specifically for adults with breast cancer undergoing lumpectomy. The commercial expansion also builds on clinical evidence supporting the technology’s potential role in breast-conserving surgery. Lumicell previously reported data from its pivotal INSITE clinical trial, including diagnostic accuracy and findings related to detection of cancerous tissue that might otherwise remain after the initial excision. The company continues to highlight real-world clinical experience, including research presented at the American Society of Breast Surgeons Annual Meeting, as part of the broader evidence base for cavity-based fluorescence imaging.
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Fluorescence Imaging Targets Residual Cancer
The LumiSystem platform represents a broader development in intraoperative cancer imaging, where medical-device technologies are being designed to provide surgeons with biological information during procedures. For breast-conserving surgery, identifying residual disease during the same operation may have implications for surgical decision-making and the possibility of avoiding some repeat procedures. Lumicell said its 2026 commercial objectives include scaling LumiSystem in the breast lumpectomy market, increasing access, and expanding adoption among cancer institutions. The company is also exploring its proprietary optical imaging technology for potential applications beyond breast cancer, including other solid-tumor indications. However, the currently cleared indication for LumiSystem remains focused on fluorescence imaging in adults with breast cancer as an adjunct for intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen.
The expansion of LumiSystem highlights the growing role of real-time fluorescence-guided imaging in cancer surgery. By providing surgeons with additional information during lumpectomy, the technology is intended to complement standard surgical judgment and pathology while supporting efforts toward more precise breast-conserving procedures. As adoption expands across cancer centers, continued clinical and real-world experience will provide additional information about how fluorescence-guided cavity imaging can be incorporated into routine breast cancer surgery.
Source: Lumicell press release
