PURE EP is a Class II medical device designated by the U.S. FDA. As such, FDA approval is possible through a 510(k) application. This means BioSig should not need human clinical data as part of the application to the agency. Proof-of-concept and pre-clinical data exist through the company’s collaboration with UCLA Labs and The Mayo Clinic. In my last article on BioSig, I reviewed very important data presented at the International Dead Sea Symposium (IDSS) by researchers at the Mayo Clinic in March 2016. Investors can view that article here >> LINK
In this article, I thought I would take a look at what BioSig Technologies is worth based on some conservative assumptions of success.