SciBase Announces Positive Top-Line Results from Pivotal Study

Excellent clinical study results for SciBase’s unique product Nevisense in the largest prospective study ever conducted in the detection of Malignant Melanoma.

The Swedish medtech company, SciBase, today announced top-line results of its pivotal study SIMPS of Nevisense, a unique non-invasive point-of-care device for detection of Malignant Melanoma, the deadliest form of skin cancer. 22 clinics across Europe and the US participated in the blinded study which was conducted under an IDE approval from the FDA. The study included 2 400 skin lesions from 1 900 patients and 260 melanomas, making this the largest prospetive study ever conducted in melanoma detection.

Nevisense achieved an overall sensitivity (the ability to accurately detect Malignant Melanoma) of 98% (lower confidence bound 95.5%) with 100% sensitivity on all stages of invasive melanomas. A specificity (the ability to accurately rule out Malignant Melanomas) of 33% (upper confidence bound 35.7%, lower confidence bound 30.4%) was achieved which is significantly higher than the study dermatologists. These results meet and exceed target study endpoints according to IDE-approval by the FDA. More detailed results will be presented pending full data analysis.

“We are very excited about these outstanding results”, says Anders Lundqvist, CEO for SciBase AB. “Current visual methods for detection and diagnosis of malignant melanoma are highly subjective and uncertain. Nevisense’s excellent outcome on sensitivity will allow for increased accuracy in diagnosis and saved lives by early detection. Dermatologists will now have access to a support tool providing them with additonal valuable and objective information not previously available. Pathologists may also benefit from the objective Nevisense output, as it has been verified in the study that not even pathology can be considered as 100% accurate. Last, but not least, a specificity higher than that of the physicians’ paves the way for a dramatic reduction of performed biopsies and substantial health care savings.”

Data from the pivotal study will provide the basis for the regulatory process for approval in the US as well as for market launch in Europe and Australia, all of which are planned for Q1 2013. SciBase is currently in the process of identifying partners for the commericalisation of Nevisense.

SciBase’s method addresses the high uncertainty in melanoma detection
Malignant melanoma is the fastest growing form of cancer and, if not detected in time, the deadliest. 50-60 million visual inspections of suspicious moles are performed annually world-wide. Despite an extensive amount of visual inspections, mortality rates are as high as 23%, which is the result of missed or late diagnosed melanomas. Early detection is critical for outcome and can be secured through extensive screening. However, today’s method for detection, visual inspection, is subjective and uncertain which, besides the risk of missing melanoma with deadly consequences, also results in a large amount of unnecessary excisions. Approximately 10-15% of screenings result in biopsies, whereof 95-97% represents biopsies of benign lesions.

SciBase provides a non-visual, accurate and objective method for the detection of malignant melanoma. The method, based on Electrical Impedance Spectroscopy (EIS), increases the physician’s ability to identify suspected malignant melanoma, or rule out benign lesions. In addition to saving lives by early detection, the SciBase method can significantly reduce the time and money spent on unnecessary excisions as suspicious lesions can be scientifically evaluated already prior to excision.

For more information, please contact:

Anders Lundqvist, CEO SciBase AB, +46 732 06 98 08


Per Svedenhag, Director Clinical & Commercial Operations SciBase AB, +46 732 06 98 01