Ann: FDA Breakthrough Device Designation, page-30

good announcement. I suppose the cash requirement going forward might suggest credit raising, but that's not necessarily a bad thing. need money to grow, as long as management is productive with it. other thing - there is no equity in this company due to prior losses. you would want to see 100+ machines sold at 500k each to make a solid dent in recovering equity. from that point, it's lots of upside, assuming the market likes the product and it differentiates and works!

fDA approval is big, hopefully the market likes the product and it scares the competition a little.