The Cambridge, Mass-based company InVivo Therapeutics recently filed a request with the FDA for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding, intended to treat complete functional spinal cord injuries (SCIs) that do not involve penetrating injury or complete severing of the spinal cord.
The designation and a subsequent approved Humanitarian Device Exemption (HDE), the company says, would allow it to commercialize the devices in the US quicker than the Pre-Market (PMA) approval process. “InVivo is confident that the results of well designed pre-clinical studies will satisfy the primary HDE requirements in this type of devastating injury where no motor or sensory function is present below the level of neurological injury,” Jack Bonasera, director of regulatory affairs, states.
Frank Reynolds, InVivo CEO, emphasizes the importance of the HUD designation, citing its significance not only for speed-to-market, but also as “a benchmark in InVivo’s commitment to patients with spinal cord injuries and other neurotrauma conditions,” Reynolds says.
InVivo Therapeutics reports that it uses polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries (SCIs).
For more information, visit www.invivotherapeutics.com.
[Source: InVivo Therapeutics]