InVivo Hopes to Begin First-In-Human Trial for Spinal Device This Year

In July 2011, InVivo Therapeutics Holdings Corp. applied for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for its biopolymer scaffolding device to treat acute spinal cord injuries (SCIs). Now, following a meeting with the FDA, the company expects the device to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway. Once the IDE application is approved, InVivo will commence a human study for the device.

When originally filed, the IDE application requested permission to start an open-label study (where both researchers and patients know what treatment is being administered) of 10 patients within days of their spinal injury. The trial was planned to take place in Boston, Mass., and Washington D.C., under principal investigators Eric Woodard, M.D., InVivo’s chief medical officer and chief of neurosurgery at New England Baptist Hospital, and Jonathan Slotkin, M.D., neurosurgeon at Washington Brain & Spine Institute. The patients would be admitted to a rehabilitation facility and follow-ups would occur for one year.

InVivo’s biopolymer scaffolding is designed to provide structural support to a damaged spinal cord to spare tissue from scarring while improving recovery and prognosis after a traumatic SCI. The implant is customized by a neurosurgeon to fit the spinal cord lesion, and then implanted into the patient’s spinal cord. The scaffold biodegrades within the body at a controlled rate over approximately 12 weeks. There is currently no effective spinal cord treatment for paralysis caused by SCIs, and according to the company, the market potential for acute SCI is estimated to be over $10 billion.

“This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” said Frank Reynolds, CEO of InVivo. “We are pleased that our core team of multidisciplinary scientists, led by my partner, Bob Langer, has had the opportunity to meet with the FDA to discuss our platform technology. We are encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during the second half of 2012.”

Robert S. Langer, Sc.D., is the David H. Koch Institute Professor at the Massachusetts Institute of Technology. He serves on InVivo’s scientific advisory board.

Later this year, InVivo plans to apply for hydrogel based treatments for SCIs and chronic pain. As the industry of cell-based therapies advances, InVivo also intends to leverage the company’s acute SCI treatments to expand to chronically injured patients.

Founded in 2005, InVivo is located in Cambridge, Mass., and provides polymer-based medical devices and technologies for the treatment of SCIs.