Fig. 2: Study design.

Intravenous administration of ONM-100 was performed ~24 h (±8 h) prior to surgery. Ten days of safety assessments (laboratory, pharmacokinetics, ECGs) followed, adverse events were monitored up to day 17 (a). During surgery, intraoperative images were obtained prior to incision and after excision of the surgical cavity (b). Immediately after excision the specimen was imaged for the presence of a positive surgical margin (c). Fluorescence images were obtained during all the standard pathology processing phases (d, e), and the H/E slices were correlated with the standard histopathology slices (f–h). i.v. intravenous, ECG electrocardiogram, H/E hematoxylin eosin, SOC standard of care.