Providing Greater Certainty In Mole Evaluation

Orlucent® has developed the first handheld fluorescent molecular imaging system to non-invasively evaluate early tissue remodeling that signals the likelihood of a mole’s transition to melanoma.

FDA Breakthough Device 
Desingation Granted

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ORLUCENT-product

Higher Fluorescence Indicates Probable Tissue Remodeling With Higher Probability To Develop Into Malignancy

Reveals Suspicious Tissue Remodeling Invisible To The Naked Eye

The Orlucent System evaluates biological activity originating from within the mole

The Product

The Orlucent System non-invasively determines the likelihood of malignancy potential for suspicious moles to provide greater certainty in clinical assessments of indeterminate pigmented lesions.

Three Simple Steps

Fluorescent biotag is topically applied then wiped away

Fluorescent biotag is topically applied then wiped away

Handheld imager captures white light and fluorescent images

Handheld imager captures white light and fluorescent images

The software provides a probability score for tissue remodeling.

The software provides a probability score for tissue remodeling

Orlucent Technology

The novel Orlucent System detects a biomarker for early stromal tissue remodeling associated with mole transition from benign to atypia.

How Does It Work?

Fluorescent Biotag
Binds to Receptors

Imager Captures
Fluorescence

Software Reports the Presence of a Malignancy Biomarker

Current Mole Evaluation Methods Are Visual And Subjective

Tissue remodeling is indicative of a nevus transforming to atypia and atypical nevi have a potential to become melanoma.1 Unfortunately, current visual assessment methods are not always sufficient to distinguish between benign or suspicious atypical moles.2-4 For this reason, biopsy is often used to gain histopathological information. However, this takes time and biopsies have some risk of causing infection and scarring.

The Orlucent System Is Biologically Based And Objective

Addressing physician desire for improved mole evaluation tools5-7 the Orlucent System was developed with the aim of increasing efficiency and reducing subjectivity and invasiveness in the identification of moles with potential to develop into malignancy. Orlucent is the first system to show biological activity without invasive biopsy and differentiate indeterminate pigmented lesions.

Current Mole Evaluation Methods Are Visual And Subjective