FDA Approves SciBase's Nevisense for Melanoma Detection

The FDA has approved the Scibase Pre-Market Approval (PMA) for Nevisense, a device for the early detection of malignant melanoma. According to the letter from the FDA the device is intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologists chooses to obtain additional information when considering a biopsy.

The company says Nevisense is now the only device of its kind available on the US market for the detection of malignant melanoma.

"The approval is a massive achievement and the result of eight years of hard work. The US Pre-Market Approval process is globally the most demanding regulatory process there is. As part of the Nevisense approval process SciBase were asked to perform the largest clinical trial of its kind ever performed within melanoma detection. The FDA also spent nearly a year reviewing SciBase's operations and processes. The approval is thereby a validation of us as a Company as well as of our product Nevisense.  Most employees in the company have been working directly or indirectly on the Approval for many years, and this really is a remarkable and nearly unique achievement given the size of our company," says Simon Grant CEO SciBase.

With this approval, SciBase plans to accelerate activities in preparation for the US introduction. The company has been doing groundwork for some time and will present the strategy for the US introduction after summer.