US Stem Cell Inc (USRM)

[Zues]

Financing studies and FDA approval for equipment/instrumentation related to stem cell procedures is secondary right now. The implications of the Court of Appeals case is priority. Initially, USRM would benefit from a favorable ruling because they are already in the market place and are a publicly traded business. If the court were to side with USRM this could open the door for stem cell treatments to be regulated by state and local medical boards.

The ruling (either way) will impact medicine on a national level. If USRM wins their appeal, the FDA would have no oversight as is the case with any autologous tissue transplant procedure done today. A company like USRM would only need to apply for a business license to operate. Any devices used to harvest stem cells would come under FDA control. But the tissue itself (SVF harvested stem cells) would not. The main argument of the FDA is full of holes and I would suggest anyone interested in this case read both sides of the argument to fully understand the dispute.