InVivo Therapeuticsa developer technologies for the treatment of spinal cord injuries and other neurotrauma conditions, announced the company has submitted an updated Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) requesting permission to begin human studies in order to test its biopolymer scaffolding for the treatment of acute spinal cord injury.
The updated IDE submission is in response to InVivo’s applications from 12 April 2012 meeting with the FDA. The filing contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device. Once approved, the IDE would allow InVivo to conduct an open-label human study to collect safety and efficacy data to support FDA approval of the first in-cord treatment for spinal cord injury. According to the company, it is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device (HUD).
“We are prepared to safely treat acute spinal cord injury patients, and in the coming months we hope to have the first opportunity to translate to humans the positive effect from the scaffold that we observed in our 2008, 2009, and 2011 non-human primate studies,” said Frank Reynolds, InVivo chief executive officer. “Our technology remains the only treatment to have demonstrated functional recovery when applied to non-human primates with spinal cord injury, and this first study has the potential to change the treatment options for neurotrauma patients forever.”
“We look forward to receiving feedback from the FDA and to getting started on this historical first-in-man clinical trial,” Reynolds added.
“We appreciate the collaborative dialogue we have had with the FDA. Since our April 2012 meeting, 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. We expect to bring a wide range of neurotrauma treatments to patients as quickly as possible with the potential for two new 510(k) products to hit the market in late 2014. In addition to the scaffolding device for SCI, we are developing products for conditions such as pain, fibrosis, and drug delivery, and we continue to make excellent progress in these applications as well,” said Brian Hess, InVivo chief technology officer.