HOW IT WORKS A breakthrough in non-invasive detection of melanoma Nevisense is the world’s first objective diagnostic support tool for non-visual detection of malignant melanoma. By gathering and analyzing precise electrical measurements in the epidermis and dermis, it provides reliable information unavailable through any other method. Through one simple procedure, it allows you to objectively evaluate suspicious lesions prior to excision. The diagnostic challenge Most dermatologists feel confident with today’s methods of visual examination. Literature shows, however, that the accuracy of clinical diagnosis of cutaneous melanoma with or without dermoscopy is far from 100%. The consequences of this uncertainty are two-fold. On the one hand, life-threatening melanoma may be missed. On the other, as a safety precaution, benign lesions are unnecessarily excised. With Nevisense, this is addressed by complementing the examination process with reliable, objective information that leads to more confident and accurate diagnoses. The Nevisense solution With Nevisense, SciBase has developed an innovative method for improving accuracy in the detection of malignant melanoma. Utilizing Electrical Impedance Spectroscopy (EIS), applied as a harmless electrical signal to the skin, Nevisense is able to provide a reliable, objective analysis of suspicious lesions which complements the physician’s regular clinical evaluations. The Nevisense method is both safe and painless. By providing valuable diagnostic information that is unavailable through other methods, it allows physicians to make more informed decisions in difficult or borderline cases. Nevisense, used as a diagnostic support tool, makes it possible to increase diagnostic accuracy, leading to both early detection of malignant melanoma and a reduction in unnecessary biopsies. Intended use Nevisense is intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma. Nevisense is designed to be used when a physician chooses to obtain additional information when considering excision. Nevisense should not be used to confirm a clinical diagnosis of melanoma. Nevisense is only for use by physicians trained in the clinical diagnosis of skin cancer. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to excise. Indication for use Nevisense is indicated only for use on primary skin lesions with a diameter between 2 mm and 20 mm; lesions that are accessible by the Nevisense probe; lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions); lesions that do not contain a scar or fibrosis consistent with previous trauma; lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions , lesions not in hair-covered areas, lesions which do not contain foreign matter; and, lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).