tj,
1) It is all speculation but what development stage company is going to quibble over personalizing their product when a company with the size and reputation of B. Braun is placing your product in their Surgical Recovery Package? The answer is going to be yes sir, and where did you want those 10,000 units delivered.
After rereading and digesting more of the Regenesis letter, which was a serious trip to the woodshed for the FDA, my money is on some major reduced regulation in the Final Order. Possibly even OTC approval for low powered PEMF devices.