InVivo Therapeutics named Barrow Neurological Institute in Phoenix a third clinical trial site for the company's acute spinal cord injury treatment.
InVivo Therapeutics is a biomaterials and biotechnology company focused on spinal cord injury treatment. The company pioneered a potential new treatment platform using a biocompatible polymer-based device to promote structural support for spinal cord regeneration while improving functional recovery prognosis after traumatic injury.
Here are five things to know about the new clinical trial:
1. Barrow Neurological Institute opened enrollment for patients with acute spinal cord injury. BNI at St. Joseph's Hospital and Medical Center is the largest dedicated neurosurgical center in the world, hosting more operative neurosurgical procedures than any other institution in the United States.
2. Nicholas Theodore, MD, director of neurosurgery spine program and director of neurotrauma at BNI, is the study's principal investigator. He focuses on spinal cord injury and published several peer-review journals and books on the topic. He also received the Mayfield Award and Tasker Award from the Congress of Neurological Surgeons.
Dr. Theodore also received a National Institutes of Health RO-1 grant to study spinal injuries and novel approaches to spine surgery. He also received a Department of Defense grant earlier this year to conduct a multi-center study evaluating cerebrospinal fluid drainage for acute SCI treatment.
3. The University of Arizona Medical Center in Tucson was the first approved clinical site in April, followed by the Carolina Medical Center in Charlotte, N.C., in May. Ali A. Baaj, MD, director of spinal neurosurgery program at the University of Arizona Medical Center, Dom Coric, MD, chief of neurosurgery at Carolinas Medical Center and William L. Bockeneck, MD, head of Carolinas Rehabilitation in Charlotte are principal investigators at their respective sites.
4. This is the company's first clinical study of the investigational degradable polymer Neuro-Spinal Scaffold. The FDA approved this pilot study to capture preliminary safety and effectiveness data. The company expects to conduct a study to obtain FDA approval for commercialization under the Humanitarian Device Exemption.
"At present, there are no effective therapies for treatment of acute thoracic spinal cord injury," said Dr. Theodore in a news release. "I am excited that InVivo's Neuro-Spinal Scaffold will fill in that void, both literally and figuratively, created after a traumatic injury to the spinal cord. The preclinical laboratory investigations have been promising with the scaffold creating a pathway unlike a trellis for a growing plant, to help direct recovery of injured pathways."
5. InVivo estimates the worldwide acute complete SCI market at more than $500 million annually. The current chronic SCI market exceeds $10 billion. Last week, the company appointed spine industry veteran Steven McAllister CFO to help drive the company into the future. During the first quarter of 2014, InVivo reported a $5.1 million net loss, but this was just half the company's reported net loss from the first quarter of 2013.
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