First Clinical Trial of Neuro-Spinal Scaffold

InVivo Therapeutics Initiates First Clinical Trial of Neuro-Spinal Scaffold

Scaffold Designed to Facilitate Neural Growth in Spinal Cord Injury


CAMBRIDGE, Mass. (April 28, 2014) – InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has begun shipment of its innovative investigational device, a degradable polymer Neuro-Spinal Scaffold for spinal cord injury (SCI) patients, for initiation of the company’s first clinical trial.
InVivo has pioneered a new treatment platform utilizing a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic SCI. In preclinical studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function.

This first clinical study, which is approved by the FDA, is a pilot trial to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The Company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).


The initial clinical site, The University of Arizona Medical Center in Tucson, AZ, has received Institutional Review Board (IRB) approval and has executed all necessary contracts with InVivo. Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrollment