InVivo Therapeutics Holdings Corporation, developer of technology for the treatment of spinal cord injuries (SCIs) and other neurotrauma conditions, has filed a request with the U.S. Food and Drug Administration (FDA) for a humanitarian use designation (HUD) for its biopolymer scaffolding product. InVivo currently is working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.
Devices eligible for HUD designation are developed to treat rare diseases or conditions. InVivo has requested designation for the use of its biopolymer scaffolding in the treatment of complete functional SCIs that do not involve penetrating injury or the complete severing of the spinal cord.
The company submitted its request after an April 2012 meeting in which InVivo and the FDA discussed the requirements for the HUD designation, and the potential for the device to be regulated and distributed under a humanitarian device exemption (HDE). An HUD designation and a subsequent approved HDE would enable InVivo to sell the devices in the United States faster than the pre-market approval process.
“The HUD/HDE provision provides a pathway for obtaining market approval from FDA for medical devices that may help people with rare diseases or conditions that otherwise would be remain unmet,” said InVivo Director of Regulatory Affairs Jack Bonasera. “InVivo is confident that the results of well designed pre-clinical studies will satisfy the primary HDE requirements in this type of devastating injury where no motor or sensory function is present below the level of neurological injury.”
“HUD designation is not only important for speed-to-market but also represents a benchmark in InVivo’s commitment to patients with spinal cord injuries and other neurotrauma conditions,” added company CEO Frank Reynolds. “Our GMP [good manufacturing practice] team is ready to go, and our clean room is humming. We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process.”
The Cambridge, Mass.-based company expects to receive feedback from the FDA on the HUD request in January.