Invivo Therapeutics Holdings Corp (NASDAQ: NVIV) is a clinical-stage and research biotech and biomaterials company that focuses on spinal cord injury treatments. The company recently announced that it got FDA acceptance for its pre-clinical module. This is one of the modules needed for InVivo’s HDE (humanitarian device exemption) application. The module’s acceptance means that the US Food and Drug Administration completed a review and had nothing further to ask about the module. However, the other two HDE modules must pass a similar review before final approval can be made.
InVivo had previously managed to get FDA approval for its HDE modular shell submission. This HDE modular shell submission comprises three different modules; a clinical data module, a manufacturing module and a pre-clinical studies module. InVivo believes that this shell submission could help give rise to more efficient review timelines and procedures with the FDA. InVivo still has a long way to go before they can get everything rolling, but they’ve so far made the right moves and steps in making sure they get the full trial done.
All about the HDE modular shell submission
The first module that InVivo has submitted to the FDA for approval is the pre-clinical module. The HDE shell submission won’t be complete until the company submits both the remaining clinical and manufacturing modules as well. The company is enrolling patients suffering from acute spinal injury into its research study dubbed INSPIRE 2.0. This study is a controlled, randomized twenty-patient trial that’s designed to get more information form
InVivo Therapeutics’s CEO and President, Richard Toselli, said it was rewarding to see its progress in Neuro-Spinal Scaffold advancements towards completing the HDE submission. He further confirmed how much they value the FDA’s collaboration in helping them achieve their goals. This company, founded by Joseph Vacanti, M.D. and Robert Langer, Sc.D. in 2005, has been making great strides in this space since its inception. It’s a publicly trading company its headquarters based in Cambridge, Massachusetts.