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www.fdanews.com/articles/171544-invivo-enrolls-third-patient-in-spinal-cord-injury-trial

InVivo Enrolls Third Patient in Spinal Cord Injury Trial

June 5, 2015

InVivo Therapeutics has enrolled a third patient in its investigational pilot trial of the Neuro-Spinal Scaffold for patients with acute spinal cord injury, the Cambridge, Mass., devicemaker announced Thursday.

The study is being conducted at the Carolinas Medical Center in Charlotte, N.C., and ultimately will enroll five patients. Upon completion of the pilot trial, the company plans a pivotal study to support FDA approval.

The device is implanted at the epicenter of the spinal cord wound and works by acting as a physical substrate for nerve sprouting. The product has received Humanitarian Use Device designation. — Jason Scott