NVIV applied for the IDE last month. These have typically been approved within 30 days (at least, as far as I can tell going back to 2007-2008). Consequently, I expect the company will get approval within days. The fact that the company has spent so much time going back and forth with the FDA suggests a high probability for approval.
The HUD designation is just a matter of numbers. What really matters is IDE approval for the 5 patient trial.
I think we'll find the HUD to be an important part of the trial design. Without it, the scaffold will take significantly longer to get to market. Finger's crossed that we hear something positive soon. The silence is deafening.
Tried to post and was rejected for adding the FDA site as a link. I wanted to mention that the criteria for IDE is listed on their site and further my musings as to why scaffolds (which are the most exciting new medical advancement of this decade) are being formatted all over the medical community and we are waiting for so long on ours.
Personally, I believe stem cell therapies will prove to be the medical advancement of the decade, however about the waiting game, the company changed their process of creating the scaffold from 3D printing to a more traditional manufacturing process. Additional delays were caused by the move to the new Kendall Square HQ with manufacturing facilities in-house (the 10K actually shows they filed a lawsuit in regards to the move) and a delay caused by a water leak (for which their insurance reimbursed NVIV $1M). The delay have reasons.