As per the seeking alpha article:
FDA's Office of Orphan Products Development issued new guidance on Humanitarian Use Device Designations in a 14-page report on January 24, 2013. This new guidance came within InVivo's initial 45-day HUD review period. In essence, the rules were changed while the FDA was in the middle of reviewing InVivo's HUD application.
This obviously explains why there has been no decision on why the 5 patient scaffold study hasn't been approved yet--this is an incredible gift--now you can buy more at a below $2 pps while awaiting the ultimate decision in March