LumaMed LLC Information

Using LumaMed’s patented technology, LumaScan™, helps assure both surgeons and patients that “they got it all” during cancer surgery. LumaScan provides intraoperative ex-vivo tissue imaging potentially useful in many cancers, including Breast Conservation Surgery (BCS; lumpectomy), oral cancer and skin cancer. Incredibly, as many as one out of every three BCS patients will require a second operation to completely remove the cancer. These second surgeries increase costs and cause undue anxiety for the patient. They also may lead to additional complications and possibly more aggressive post-surgical interventions. Indeed, for patients with a variety of solid cancers, cancer cells left inadvertently left in the tumor bed can reduce survival rates and increase morbidity. LumaScan provides surgeons with a tool that can help accurately visualize the line that separates normal, healthy tissue from diseased, cancerous tissue. Although methylene blue is used on the excised tissue, LumaScan helps surgeons visualize the lines between normal and diseased tissue without introducing new drugs or markers of any type into the patient thus assuring patient safety. The ability to help the physician see cancer margins with close agreement with conventional histopathology has enormous value in many of the estimated 11 million solid tumor surgeries conducted each year in the US. This is especially important where tissue conservation is critical, such as in breast cancer surgery, Mohs surgery for skin cancer and surgery for oral/head and neck cancers. Product Descriptions LumaScan is a table-top system designed to hold a proprietary disposable tray outfitted with a calibration target and an optical window. The device functions as an inverted microscope and is a Class 1 device exempt from FDA 510(k) clearance requirements. Our technology is adjunctive in that all tissue samples will continue to be evaluated by conventional histopathology for definitive analysis.