InVivo Therapeutics (OTC:NVIV) wants the FDA’s blessing for a human trial of its biopolymer scaffold to treat traumatic spinal cord injuries.
The Cambridge, Mass.-based biotech firm said it filed an investigational device exemption application with the federal watchdog agency seeking permission to run a 10-patient trial of the device. It’s designed to "protect and support spinal tissue and prevent secondary injury, including inflammation and glial scarring, following traumatic spinal cord injury," according to a press release.
The study would follow the patients for a year after implantation with the device at centers in Boston and Washington; the subjects will be sent to rehabilitation facilities following the implantation procedures. The study’s main endpoint is safety data; secondary endpoints include motor and sensory recovery, determined according to the American Spinal Injury Assn.’s impairment score.
"InVivo’s first regulatory submission for human testing is a major step forward in realizing the promise of our technology for spinal cord injury patients," CEO Frank Reynolds said in prepared remarks. "Our goal for this initial study is to safely minimize the secondary injury processes, thereby allowing the body to reorganize locally toward functional recovery through the spared healthy tissue. This process, known as neuroplasticity, may result in partial functional recovery."
It’s at least the second time Reynolds has touted an IDE application. In a December 2009 email, he wrote that InVivo believes the therapy "represents the most significant development in the history [of] spinal cord injury treatment."
"This is Huge!!” Reynolds wrote. In prepared remarks issued the same day, he said the company anticipated revenues from its first product to exceed the billion-dollar mark.
The InVivo implant is shaped by the implanting surgeon to conform to each patient’s spinal cord lesion and is designed to dissolve over about 12 weeks. The company is also working on an injectable hydrogel to carry therapeutics agents to the injury site without requiring invasive surgery.
