US Stem Cell Inc (USRM)

[Dragon Lady]

The skin graft example provided by the FDA was very weak. When we do tendon grafts we also dissect muscle tissue as tendons attach muscles to bones. The muscle tissue is not good for grafting purposes and is cut away from the tendon on a back table as part of the graft prep. In this process we alter the tissue as needed and then return it back to the patient in a different part of their anatomy (hamstring tendons used for ACL recon in the knee for example). The FDA has no oversight with autologous tissue related procedures.

When patients receive autologous blood transfusions (transfusions of their own blood) during surgery the blood recovered from suction is sent to a machine that cleans and then separates red blood cells from the fluid containing, fat, bone particles, and saline, and then returns scrubbed red blood cells back into the patient via transfusion. Again, the tissue, or in this case blood, is altered before being returned to the patient. And because it is blood products, there is no single destination within the body as blood circulates everywhere.

Personally, I think the judges have already made their minds up per the written brief previously provided and the hearing was mostly a formality. I expect them to send it back for trial. We will see.

AMAZINGLY GOOD EXAMPLE Zues, spot on !!!

They should have had you in the room as back-up to take the FDA kid to the woodshed with those simple to understand facts.

Damn, it's that EXACT kind of "lay person level" explanation these judges need and must hear, if they are even slightly confused by all the FDA jargon and smoke n mirrors !

I hadn't even thought about blood- damn that is good info !

How bout dialysis, scrubbing out the toxins and re-introducing "modified" new and better blood back to same patient, same day?

DRUG according to FDA, right LOL !!!

Yeah - you could have nailed their hide to the wall with those two additional examples above, just smoked um in front of that panel of judges.

COMMON SENSE = the BEST DEFENSES !!

Keeping it at a level in which you figure you could walk into a room of non medical people and non FDA attorneys and explain it to them - and at least 75% of them would get the majority of what you're explaining, as in "get it" to to the bottom line and "see" the RIDICULOUSNESS of something like "DRUG" being inserted into the argument !!