InVivo Therapeutics wins humanitarian use device status from the FDA for its biopolymer scaffold, designed to treat spinal cord injuries, clearing the way for approval of a pivotal trial.
InVivo Therapeutics (OTC:NVIV) said the FDA deemed its biopolymer scaffold, designed to treat spinal cord injuries, to be a humanitarian use device.
The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called “orphan” conditions.
InVivo, which filed for HUD approval in late 2012, said the designation is for treating “recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord,” according to a press release.
