InVivo Therapeutics, a medical device manufacturer based in Cambridge, Massachusetts, is seeking humanitarian device exemption from the United States Food and Drug Administration (FDA) for its biopolymer scaffolding product. The scaffolding technology is designed for the treatment of non-severing acute spinal cord injuries.
According to information in a press release by the company, the implantable biopolymer scaffolding technology is being developed with Langer Lab, a research facility at Massachusetts Institute of Technology. The device is designed to completely treat functional spinal cord injuries that do not involve penetration or severing.
Frank Reynolds is CEO at InVivo Therapeutics. In prepared remarks, he 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. Our GMP team is ready to go, and our clean room is humming." He continued, "We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process."
With a humanitarian exemption for the device, the company would be able to avoid lots of bureaucratic delays associated with regulatory approval. For instance, this procedure would give the company the ability to commercialize the technology faster than the traditional premarket approval process.
In 2011, the company filed an IED application with the FDA for permission to run a small trial of its biopolymer scaffolding technology. The study will follow patients for one year following implantation at Washington and Boston centers. Patients will then be observed in rehabilitation facilities.
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