InVivo Therapeutics Holding Corp recently submitted an updated Investigational Device Exemption (IDE) to the FDA. Invivo’s updated IDE requests permission from the FDA to begin human studies to test its biopolymer scaffolding for the treatment of acute spinal cord injury (SCI). The company notes that its updated IDE submission contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device.
A recent news release reports that upon approval, the IDE will allow InVivo to conduct an open-label human study in order to collect safety and efficacy data to support FDA approval of what it says is the first in-cord treatment for SCI. The company adds that it is working with the FDA to have the scaffolding device designated as a Humanitarian Use Device (HUD).
Frank Reynolds, CEO, InVivo, notes that, “In the coming months, we hope to have the first opportunity to translate to humans the positive effect from scaffold that we observed in our 2008, 2009, and 2011 nonhuman primate studies.”
Reynolds goes on to thank Eric Woodward, MD, chief medical officer, InVivo, and Brian Hess, PhD, chief technology officer, and their teams for their efforts and commitment to SCI patients. Hess emphasizes the company’s appreciation of the collaborative effort with the FDA, noting that since the company’s meeting with the organization in April 2012, “we’ve established regulatory processes to treat neurotrauma with biomaterials, and we’ve completed knowledge transfer with the FDA that we believe will benefit all of our additional products in development,” Hess says.
[Souce: InVivo Therapeutics Holdings Corp]