Lumicell said it won an investigational device exemption from the FDA for a pilot feasibility trial of its imaging system for breast cancer surgeries.
The study is slated to be conducted at the Mass. General Hospital in Boston, the company said.
Funding for Lumicell’s pre-clinical toxicology tests and the manufacturing of the imaging system has come from the National Cancer Institute, said the company. Lumicell also secured additional NCI funding to support the feasibility study in breast cancer.
“Launching a feasibility study for intraoperative imaging of breast cancer during surgery is a critical next step for 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,” CEO David Lee said in prepared remarks.
Wellesley, Mass.-based Lumicell recently completed a phase 1 safety study of its imaging device for the indications of breast cancer and sarcoma with no agent-related adverse events observed, said the company.
“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. 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,” Lee said in a press release.