Frank has mentioned numerous times the possibility of partnering with a device manufacturer to produce the products. I believe NVIV plans to do so with the scaffold once FDA gives approval in order to generate funding for the next product in the pipeline.
I thought this entire year was dedicated to the installation of 3-D printers and the other day someone said that they were printing but not in 3-D??? Why would they not want to keep their manufacturing right there at home??? With the advances being made at the moment with stem cells and scaffolds (a nose, a trachea, ect) I can see where INVIVO is in a position to advance their scaffold research to the clear blue sky. They are saying it takes only 3-weeks to create an ear or a nose in the lab using stem cells and scaffolds. Langer is right in the mix with this new facility. What say you???
Hi Jack, they changed the way they are going to produce the scaffolds so they can do it in-house. I am not sure if they are using DDD or not but they wanted more control of the creation and the new facility is now up and running.
Frank's last presentation was interesting partly because it sounded like they originally planned on using 3D printers to custom formed scaffold for each injury but the FDA has indicated cutting to fit standard 3D printed scaffold would be ok with them. Less complicated for sure. Along with this was NVIV's earlier press release that referred to the initial patients to be those with bruising injury to the SC and not the penetrating injury originally planned for in the Phase I trial.
A penetrating injury would naturally create the need for customized scaffold shapes whereas I'm guessing a bruising injury would not.
All a bit mysterious but each change of program sounds like it makes it simpler and therefore less likely to have unforseen surprises.