InVivo Therapeutics Adds Site to Neuro-Spinal Scaffold Trial

The University of Kansas Medical Center in Kansas City, Kan., has been added as a clinical site in InVivo Therapeutics’ ongoing Investigational Device Exemption (IDE) pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Paul Arnold, M.D., professor of neurosurgery and vice chair of research, has been named principal investigator at the site.

“We look forward to participating in this exciting pilot study of an innovative device that is targeted at addressing the huge unmet medical need in the treatment of acute spinal cord injury patients,” Arnold said.

“We welcome Dr. Arnold and University of Kansas Medical Center into InVivo’s ongoing pilot study, which was recently reopened for concurrent enrollment of the final three patients,” said Mark Perrin, InVivo’s CEO and chairman, said. “We are pleased to be working with a researcher of Dr. Arnold’s caliber, and are pleased as well that we now have nine sites open to enroll subjects.”

InVivo’s first patient was enrolled in October 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz. In January this year, InVivo announced enrollment of its second patient in the study at Carolinas Medical Center in Charlotte, N.C.

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the U.S. Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.

Based in Cambridge, Mass., InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries.