1. Fluorescent Biotag Binds to Receptors

The system uses a proprietary biocompatible fluorescent peptide dye that binds to over expressed biomarker protein-receptors in the mole macroenvironment during tissue remodeling.

2. Imager Exposes Fluorescence

The handheld imager uses near infrared light to excite the retained dye to capture the fluorescence from the target tissue delineating tissue undergoing remodeling as part of the transition process.

3. Software Reports Tissue Remodeling

The analysis software integrates tissue remodeling, including neoangiogensis and tissue reorganization, with nevus characteristics (e.g., size, shape, and pigment) to create a probability score for the presence of tissue remodeling associated with the transition from benign to atypia.

The Orlucent system is based on the established science of tissue remodeling during nevus transformation.

Multiple studies show the use of a fluorescing peptide to bind to the alpha-v beta-3 (αvβ3) integrin to be both sensitive and specific to melanocytic tissue remodeling within the mole macroenvironment.8-11

The Orlucent technology is unlike spectral imaging or impedance-based products that evaluate structural tissue reorganization. The Orlucent system identifies the presence of a biomarker preceding the structural changes that occur during transition from benign to atypia.