Grapefruit USA Inc (GPFT)

[deanjanes]

Tashiboy, thanks for the help as I thought I'd answered that question atleast once or twice. The Medtronic O-arm is a nice system, it costs nearly double as much as the DViS and is no where near real time. If they want to perform real time 3D they would need to redesign their system, cross my patent and use an entirely different detector. Their device stopped short of considering 3D and more importantly 3D real time, but as I stated before it is a nice 360 2D system, just very limited. The good news is they are interested in us as well as their competitor Stryker. Stryker more so as they have no product to answer Medtronics device and package product with Navigation.

Yes, CT is an aspect of our 510k which is adding to the delay of our approval for now. Nothing really over the top, we just have to be careful from this point forward, especially in a new political environment and the latest bashing the FDA has received in the media.

We are not concerned, nor do we think the O-arm is a direct competitor as they have a narrow market focus, a crazy high price and their own system issues. Since the O-arm opens up it has had problems getting stuck in the closed position, I'm told this has happened more than once with a patient on the table.

Dean