[1][2][3] The efficacy and safety of pegulicianine were evaluated in a multicenter, intra-participant controlled clinical trial (NCT03686215) of participants with breast cancer undergoing lumpectomy surgery.

[3] A total of 357 participants underwent image-guided surgery with the Lumicell DVS following standard of care lumpectomy.

[3] The study assessed the proportion of participants receiving pegulicianine who had residual cancer detected and removed after the standard of care lumpectomy.

[3] The study also assessed the image-level sensitivity (ability to designate an imaged region with disease as positive) and specificity (ability to designate an imaged region without disease as negative) for detection of cancer in the lumpectomy cavity.

[3] The FDA granted the application for pegulicianine fast track and priority review designations.