InVivo adds 19th site at University of Virginia site to Inspire study

InVivo Therapeutics (NSDQ:NVIV) is continuing to add sites to the Inspire study of its NeuroSpinal Scaffold, announcing today that it added a new site at the Charlottesville’s University of Virginia Health System.

The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

“Spinal cord injury is a devastating condition with severe personal and societal costs. We are excited to participate in this innovative study that has the potential to improve the outcomes in patients with the worst spinal cord injuries,” principal investigator Dr. Chris Shaffrey said in prepared remarks.

The new addition brings the total number of sites for the trial up to 19, the company said.

“We look forward to having Dr. Shaffrey and his team be a part of the Inspire study. The University of Virginia’s geographical reach and experience with spinal cord injury trials will be an asset as we seek to enroll additional Inspire subjects,” CEO Mark Perrin said in a press release.

In March, InVivo said it added Philadelphia’s Thomas Jefferson University Hospital as a clinical site. A day earlier, InVivo saw shares jump as much as 25% after announcing positive 6-month results for its 5th patient in the Inspire study of its neuro-spinal scaffold.

The company has shown significant momentum with its Inspire trial, announcing the addition of 2 clinical sites, in Greenville, N.C. and Louisville, Ky., as well as reporting that the FDA  accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its neuro-spinal scaffold.

InVivo said its HDE modular shell for the Neuro-Spinal Scaffold is composed of 3 modules, including a preclinical study module, manufacturing module and clinical data module. The submission of the final module triggers a 75-day HDE review clock, the company said.

In late February, InVivo said the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial.

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