Lumicell is highlighting results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, published April 27 in NEJM Evidence and to be presented at the American Society of Breast Surgeons (ASBS) annual meeting.
The study explored the safety of efficacy of the company's direct visualization system to identify residual breast cancer following lumpectomy. The system identified cancer remaining after lumpectomy in about 8% of patients. In most patients, pathology showed negative margins and would have left this tumor behind.
Additionally, the additional residual cancer identified by the system measured 1 mm to 13 mm and included areas of low- and high-grade tumor in patients across all tumor types. Plus, 14.5% of patients with positive margins were converted to final negative margins.
On the safety side, the study also found that Lumicell's investigational optical imaging agent Lumisight (pegulicianine) had a serious adverse event rate of 0.5%, similar to that of other contrast agents.
The U.S. Food and Drug Administration (FDA) granted Lumisight fast-track designation and the Lumicell direct visualization system breakthrough device designation. The new drug application for LUMISIGHT was submitted to the FDA in March and the premarket application for the direct visualization system was submitted to the FDA in April.