InVivo has received HUD designation for the use of its biopolymer scaffolding for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. This should allow them to bring the product to market several years faster than other regulatory paths would have allowed.
The company expects the device to be regulated and distributed under a Humanitarian Device Exemption (HDE) pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA.