InVivo Therapeutics Holdings, a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today detailed results of its meeting with the U.S. Food and Drug Administration (FDA) for discussion of the investigational device exemption (IDE) previously filed for InVivo’s biopolymer scaffolding for the treatment of acute spinal cord injuries.
Before InVivo can advance to human clinical studies, the FDA must approve the company’s IDE filing, for which the FDA has agreed to an open dialogue as the application moves toward gaining approval.
Following the meeting, the company said it anticipates that the biopolymer scaffolding device will be regulated under the humanitarian use device/humanitarian device exemption (HUD/HDE) pathway.
“This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” Frank Reynolds, InVivo’s CEO stated in the press release. “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.”
InVivo later this year plans to submit hydrogel-based applications to the FDA for the treatments of SCI and chronic pain. The company also intends to leverage its acute SCI treatments to expand to chronically injured patients.
For more information visit www.invivotherapeutics.com
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