Lumicell Announces FDA Approval to Launch Feasibility Study

Trial is funded by National Cancer Institute grant Wellesley, Mass., May 20, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study for intraoperative imaging of breast cancer during surgery. The study will be conducted at Massachusetts General Hospital (MGH). Further trial information can be found here: https://clinicaltrials.gov/show/NCT02438358. The National Cancer Institute (NCI) has funded Lumicell’s pre-clinical toxicology tests and the manufacturing of Lumicell’s imaging agent for the feasibility (pilot) clinical trials through the NCI Experimental Therapeutics (NExT) program. Further, in collaboration with the Director of the Breast Cancer Program at MGH, Lumicell helped secure additional NCI funding from an R21 Early Phase Trials program to support the feasibility study in breast cancer. Lumicell recently completed a Phase 1 safety study with its leading imaging agent LUM015 at Duke University Medical Center in the indications of breast cancer and sarcoma with no agent-related adverse events observed. The Principal Investigator for the feasibility study is Dr. Barbara Smith, Director, Breast Cancer Program and Co-Director, Gillette Center for Women’s Cancer at MGH. “Launching a feasibility study for intraoperative imaging of breast cancer during surgery is a critical next step for Lumicell,” said W. David Lee, CEO of Lumicell. “The NCI grant allows our team to demonstrate the efficacy of our system in reducing rates of positive margins and repeat surgeries. By enabling surgeons to remove sub-millimeter residual cancer, we expect to improve patient outcomes.” “The NCI is the nation’s leader in cancer research and their support of our work has been critical as we move our technology forward,” added W. David Lee. “NCI’s funding of our pre-clinical toxicity studies and the manufacturing of our imaging agent, LUM015, for the feasibility study through the NCI NExT program, has helped drive our early successes.” Lumicell is addressing the number one challenge in cancer surgery – the need to remove all cancer cells within the tumor bed during the first surgery. In the field of cancer surgery, the goal is clean margins. Lumicell’s intraoperative detection system provides surgeons with the needed tools to perform a thorough removal of any residual cancer cells in real-time within the tumor bed thus eliminating the need for repeat surgeries due to positive margins or local recurrence.Lumicell’s surgical system combines a lightweight hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent. This image-guided technology is designed to fit within the existing surgical workflow. The company’s devices and imaging agents are optimized for the specific cancer-type and surgical procedure. About Lumicell, Inc. Lumicell is a leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative imaging system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable imaging agent and a novel hand-held imaging device with exquisite single-cell detection. The unprecedented ability to see and remove all cancer cells during the initial surgery has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is initially investigating its imaging system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications will include surgeries for lung, prostate, ovarian, colorectal and brain cancers. 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