Lumicell said yesterday it won FDA approval to launch a pilot feasibility study of its intraoperative imaging system for patients with esophageal, colorectal and pancreatic cancers.
The study is supported by a grant from the National Cancer Institute’s Spore program, the company said, and will be conducted at Massachusetts General Hospital in Boston.
“The launch of a feasibility study in gastrointestinal cancers is an important next step for our company. We are proud to partner with the Dana-Farber Cancer Institute and MGH to conduct this study. The Spore grant will allow our team to test our imaging system in patients with esophageal, colorectal and pancreatic cancers. We will seek to demonstrate that our technology detects cancer as confirmed by pathology,” CEO David Lee said in a press release.
Lumicell’s surgical imaging system is made up of a hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent, the company said. The technology is designed to be optimized for specific cancer-types and surgical procedures.
The company said it aims to produce an imaging device that will allow for the thorough removal of all residual cancer cells within the tumor bed to eliminate the need for repeat surgeries and retreatments.
“NCI and the Spore Program are both leaders in cancer research and their support of this study in gastrointestinal cancers is a critical step in moving this technology forward. Our study includes three surgical oncologists from both Dana Farber/Brigham and Women’s Cancer Center and MGH. I truly look forward to working with this team toward the goal of demonstrating the effectiveness of this surgical system,” Dana-Farber Cancer Institute gastrointestinal cancer center director Dr. Charles Fuchs said in a press release.
In May, Lumicell won an investigational device exemption from the FDA for a pilot feasibility trial of its imaging system for breast cancer surgeries.
The study is being conducted at the MGH. Funding for Lumicell’s pre-clinical toxicology tests and the manufacturing of the imaging system has come from the National Cancer Institute, the company said. Lumicell also secured additional NCI funding to support the feasibility study in breast cancer.
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