"InVivo has requested designation for the use of its biopolymer scaffolding in the treatment of complete functional spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord. "
They originally indicated the first trial would be in penetrating injuries, gunshot, knife etc.
However now it looks to be the much more common non penetrating injuries.
I read this as very good since the penetrating injuries can be a very mixed bag and maybe hard to find perfect candidates whereas non penetratingare much more common and I suspect the better candidates for this treatment, and much faster patient enrollment.
However whereas the penetrating injury already has an open chord so inserting the scaffold would not increase trauma to the chord the non pentrating injury requires an incision into the chord, which creates in some way more injury.
In fact this is one of the advantages of the hydrogell since an injection into the chord is the least intrusive.
I'm assuming all this has been discussed with the FDA and they are on board. This may have been part of why the time to submitting the HUD aplication has taken longer than we expected, although I still think getting lab set up and running was a part of that.
Important find. Thanks for pointing that out, Mr rx. Looks like the Co is still doing it's homework and working closely with the FDA. This attention to detail, and keeping the eye on the ball, may save us a lot of time and trouble.