InVivo Therapeutics Requests Humanitarian Use Device Designation with FDA





InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently 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 spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord. The request comes 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 Humanitarian Device Exemption (HDE) would enable InVivo to commercialize the devices in the United States faster than the Pre-Market (PMA) approval process. Said InVivo Director of Regulatory Affairs Jack Bonasera, 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. 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 InVivos commitment to patients with spinal cord injuries and other neurotrauma conditions. Our GMP 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,” said Frank Reynolds, InVivo Chief Executive Officer. The Company expects to receive feedback from the FDA on the HUD request in January 2013. About InVivo Therapeutics InVivo Therapeutics Holdings Corp. is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious 2011 David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine.