Lumicell is working to change the landscape of cancer surgery with a hand-held imaging system that has the potential to help to identify cancer cells left behind on the tumor cavity walls and take action in real-time to improve patient outcomes.
Lumicell is working to change the number one challenge in cancer surgery – the need to remove cancer cells during the first surgery while preserving healthy tissue.
Lumicell Completes Enrollment in the INSITE Pivotal Trial for Intraoperative Breast Cancer Detection & Removal
Lumicell, Inc - In a significant milestone for breast cancer patients and advancement toward submission of its Lumicell Imaging System for regulatory approval, Lumicell has completed enrollment in their Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal clinical trial (NCT03686215). This trial was designed to further assess the safety and effectiveness of the Lumicell Imaging System for the detection and removal of residual cancer during the initial breast-conserving surgery.
Lumicell Granted Fast Track Designation Approval by the FDA for Breast Cancer Treatment
Lumicell, Inc. today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer. Fast Track designation represents another major milestone in Lumicell’s path to FDA approval.