The US Food and Drug Administration has approved the Scibase Pre-Market Approval (PMA) for its product Nevisense.
Nevisense is SciBase’s device for the early detection of malignant melanoma. With the approval, SciBase can now market and sell Nevisense in the US. 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 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. “It’s no secret that the US market is the world’s largest and most profitable market for medical devices and in the long term, it represents a huge growth potential for us.”