InVivo Therapeutics ($NVIV) is seeking FDA approval for its spinal scaffolding device, and the company is appealing to the agency for a Humanitarian Use Device designation, which would speed up the regulatory process.
InVivo's tech is a biopolymer scaffold designed to treat acute spinal cord injuries, and the company contends that its product is a fit for the FDA's humanitarian pathway, which is designed to fill unmet patient needs by speeding devices to market.
The company, founded in 2005 with technology co-invented by MIT's Robert Langer, is eyeing an approval-oriented clinical trial to start in 2013, and the humanitarian route would be faster than a traditional PMA, CEO Frank Reynolds said.
"HUD designation is not only important for speed-to-market but also represents a benchmark in InVivo's commitment to patients with spinal cord injuries and other neurotrauma conditions," Reynolds said in a statement. "Our GMP team is ready to go, and our clean room is humming. We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process."
At the moment, there is no effective treatment for paralysis caused by spinal cord injury, InVivo says, and its scaffolding, once approved, would enter a market the company estimates at $10 billion a year. In the meantime, InVivo has been steadily growing its bottom line, pulling in $8 million in net income last quarter, compared to $3 million in the same period in 2011.
- read InVivo's release