InVivo Therapeutics' spinal cord scaffold wins FDA nod

April 4, 2013 by Brad Perriello

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

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.

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"The company expects the device to be regulated and distributed under a humanitarian device exemption pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA," according to the release. "The trial will be conducted to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use."