"Verisante's skin cancer device, called Aura, is game-changing technology for dermatologists. Yet the company's share price is low and its market cap is about $20M. One reason for the undervaluation is that the skin cancer detection instrument has not yet been approved by the FDA. The firm is talking to consultants about how to best get its device into the regulatory approval system. That can be a big challenge for a small company. A device may be approved in Canada, Europe, Japan and China, but the big market is the U.S., and that requires FDA approval."
"There is only one other device on the market that's of significance in terms of competition. . .but Verisante's technology looks to be more accurate, which is very important. It also has a number of other significant advantages, one being that it's much faster—you can scan a whole body rapidly. The U.S. market is a goal, but it's probably down the road, after some U.S.-based studies are done. Verisante's game plan is to roll the Aura out overseas first, to help finance the U.S. studies."