Dom Coric, M.D., of Carolina Neurosurgery & Spine Associates, chief of neurosurgery at Carolinas Medical Center, is a co-principal investigator. William L. Bockenek, M.D., chief medical officer of Carolinas Rehabilitation, part of the Carolinas HealthCare System, and chairman of the Department of Physical Medicine and Rehabilitation at Carolinas Medical Center, is also a co-principal investigator.
This is the company’s first clinical study of its degradable polymer Neuro-Spinal Scaffold. The 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 device in up to five human 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).
Coric said: “We are excited to initiate the study of this innovative surgical treatment for neurologically devastating spinal cord injury at the Carolinas Medical Center.”
Cambridge, Mass.-based InVivo has developed a new treatment platform using 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 use of the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function, according to the company.
There is currently no effective treatment for paralysis caused by SCI. The company estimates the worldwide market for treating acute complete SCI to be more than $500 million annually, and the chronic SCI market to be over $10 billion. This is the first in-human study of InVivo’s novel investigational device, a critical step in the company’s business objective to address a major unmet need for patients with SCI.
InVivowas founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital.