Clinical Evidence Supporting Nevisense

Based on research from The Karolinska Institute, Nevisense has over a decade of validation, with more than 85 publications documenting its effectiveness. The pivotal study involved 2,416 lesions across Europe and the U.S., demonstrating a 97% sensitivity for melanoma detection, a 37.5% specificity, and a 99% Negative Predictive Value (NPV), showing its potential to reduce unnecessary excisions.

Key Clinical Developments

• Method development: Conducted over seven studies with 1,200 patients
• Algorithm Training: Nearly 2,000 patients at 19 sites in Europe
• Pivotal Study: The study was conducted in both Europe and the US with 22 participating clinics in the UK, Germany, Sweden, Hungary, Austria, Spain and the US. A total of 2,416 lesions and 1,951 patients were included in the study
  The pivotal study was performed with the objective to provide scientific evidence of the accuracy of Nevisense in detecting malignant melanoma, but also to provide scientific evidence of the method’s accuracy and safety as the basis for regulatory approval.
  The study, an international, multicenter, prospective clinical trial, was conducted at both private and academic dermatological centers was approved by national and local ethics committees/institutional boards and carried out in accordance with the International Conference of Harmonization of Good Clinical Practice (ICH-GCP) and ISO 14155:1-2.
• Post Pivotal StudyAnalysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions
  A total of 118 patients were enrolled at two centers in Australia to evaluate the influence of adding a Nevisense EIS at baseline to suspicious melanocytic lesions undergoing routine short-term digital dermoscopy imaging (SDDI). The conclusion was that adding Nevisense in compliance with the study protocol achieved good diagnostic accuracy while avoiding the need of follow up by 47%.

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