SciBase has announced positive results of its non-invasive point-of-care Nevisense device from the pivotal SIMPS study.
The patented Nevisense device, which includes an electrode on a hand-held probe, utilizes electrical impedance spectroscopy (EIS) to detect and monitor skin tissue alterations.
Conducted under an investigational device exemption (IDE) approval from the US Food and Drug Administration(FDA), the blinded, prospective study included 22 clinics across Europe and the US as well as 2 400 skin lesions from 1 900 patients and 260 melanomas.
Nevisense achieved an overall sensitivity of 98% (lower confidence bound 95.5%) with 100% sensitivity on all stages of invasive melanomas as well as a specificity of 33% (upper confidence bound 35.7%, lower confidence bound 30.4%).
The results meet and exceed target study endpoints, according to IDE-approval by the FDA.
SciBase CEO Anders Lundqvist said Nevisense’s outcome on sensitivity will allow for increased accuracy in diagnosis and save lives by early detection.
"Pathologists may also benefit from the objective Nevisense output, as the study results confirm that even pathology is far from 100% accurate," Lundqvist added.
"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."
The company said the study data 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.