InVivo Therapeutics (OTC:NVIV) hopes to begin testing in humans in an open-label safety and efficacy study now that it’s updated its submission for an investigational device exemption submission for its spinal cord injury treatment.
InVivo filed the original investigational device exemption application in July 2011, but has yet to be approved.
"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," CTO Brian Hess said in a statement.
The Cambridge, Mass.-based medical device company is also asking the FDA to qualify the device as a "humanitarian use device," hoping the designation will help commercialize the product more quickly than the pre-market approval process. The device is a scaffold designed to prevent a 2nd injury in patients with traumatic spine injuries that don’t involve penetrated or severed spinal cords.
Back in September 2011, CEO Frank Reynolds told MassDevice.com that he hoped the federal watchdog agency would give a green light by early 2012.
