Image-guidance firm Lumicell has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) allowing it to launch a pilot study for intraoperative imaging of breast cancer during surgery.
The study, to be conducted at Massachusetts General Hospital in Boston, will test the Lumicell system's ability to reduce rates of positive margins and repeat surgeries, the company said. The technology is expected to improve patient outcomes by enabling surgeons to remove residual cancers less than 1 mm in size, Lumicell added.
The study is being funded by the U.S. National Cancer Institute (NCI), which also funded Lumicell's preclinical toxicology tests and the manufacturing of the company's imaging agent for the trial.
