Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring
during melanocytic transition and atypia development in the skin. SFI analyzes the topical
staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the
skin, together with the visible feature characteristics. The system provides a biometric
score corresponding to the dye staining, a structural score, and a composite SFI score to
quantify the presence of tissue remodeling and the process of melanocytic transition in the
skin.

Inclusion Criteria:

1. Subjects with a pigmented skin lesion recommended for a skin biopsy.

2. A lesion that is accessible to the imaging device, with at least 1 cm of skin around
the lesion that is accessible to the MDS.

3. At least 21 years old.

4. Written, signed, and dated informed consent

5. Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion Criteria:

1. Lesion is less than 1 centimeter from the eyes.

2. Lesion is on the palms of the hands or soles of the feet.

3. Mucosal lesion.

4. Ulcerated lesion.

5. Subject is pregnant or planning to become pregnant during the study period.

6. Patients who are mentally or physically unable to comply with all aspects of the
study.

7. Any subject undergoing chemotherapy.

8. Any lesion that has been treated with local anesthesia such as lidocaine prior to
enrollment that would confound study results.