InVivo Therapeutics (NSDQ:NVIV) shows no signs of stopping the momentum in its Inspire trial, announcing today that it added Philadelphia’s Thomas Jefferson University Hospital as a clinical site for the Inspire study of its neuro-spinal scaffold, designed to treat patients with complete thoracic AIS A spinal cord injuries.
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.
“We welcome Dr. Harrop and his team to The Inspire Study. Their emphasis on serving the enormous unmet medical need in SCI is clearly demonstrated by their hospital being designated as an SCI Model Systems Center,” CEO Mark Perrin said in a press release.
The addition brings the total number of sites for the study up to 18, InVivo reported.
“Jefferson has established a deep-seated commitment to serving spinal cord injury patients, and we are thrilled to be taking part in InVivo’s novel clinical trial,” principal investigator Dr. James Harrop said in a prepared statement.
Yesterday, 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 over the past 2 weeks, announcing the addition of 2 clinical sites, in Greenville, N.C. and Louisville, Ky., to its Inspire study, 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.
Last Monday, 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.
