Following the meeting, the Company is expecting the biopolymer scaffolding device to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway. Before human clinical studies can commence, the FDA must approve the Company’s IDE filing, for which the FDA has agreed to an open dialogue as part of the final process toward gaining approval. During the FDA meeting, the Company addressed several points in the FDA’s feedback including the proposed design and clinical protocol for the study.
“This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” said Frank Reynolds, InVivo’s Chief Executive Officer. “We are pleased that our core team of multidisciplinary scientists, led by my partner, Bob Langer, has had the opportunity to meet with the FDA to discuss our platform technology. We are encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during the second half of 2012.”
Later in 2012, the Company plans to submit hydrogel-based applications to the FDA for the treatments of SCI and chronic pain. As the industry of cell-based therapies advances, InVivo also intends to leverage the Company’s acute SCI treatments to expand to chronically injured patients. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffolding to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovering and prognosis after a traumatic SCI. Today, there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential for acute SCI is estimated to be over $10 billion.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury. The Company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, ScD., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, data from a Company study was published in the Journal of Neuroscience Methods and won the prestigious 2011 Apple Award from the American Spinal Injury Association recognizing excellence in SCI research. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com