Efficient. Accurate. Objective.
Through a series of comprehensive clinical studies, Nevisense has proven to deliver accurate, objective, adjunctive information to complement the visual examination.
Unique complementary information
Nevisense equips providers with a unique non-invasive EIS analysis of atypical pigmented lesions.. For cutaneous lesions with unclear clinical or historical signs of melanoma, it allows dermatologists to obtain further information, complementary to visual examination, prior to a decision to excise.
Nevisense has a proven diagnostic accuracy in the detection of malignant melanoma in three consecutive studies with more than 4,000 lesions. In the pivotal study with a total inclusion of more than 2,400 lesions, the Nevisense system achieved a sensitivity of 97% in the target population. It also has a proven specificity of 34% on lesions with clinical suspicion of malignant melanoma.
Result from Updated Primary Effectiveness Analysis Population in the Pivotal Study conducted under IDE #G090108 (PMA P150046) Nevisense sensitivity and specificity for melanoma were 95.9% and 31.3%, respectively, based on the analysis of the primary effectiveness population; and 96.6% and 34.4%, respectively, based on the analysis of the updated primary efficacy population in the Pivotal Study.
Visual inspection, whether through dermoscopy or with the naked eye, is inherently subjective. Nevisense enables providers to complement their expertise with an objective analysis of cellular characteristics, thereby leading to more informed decisions in difficult or borderline cases.