CAMBRIDGE, Mass. (June 26, 2014) – InVivo Therapeutics Holdings Corp. (NVIV) announced today that a third clinical site, the Barrow Neurological Institute (BNI) in Phoenix, AZ, is now open for enrollment for patients with acute spinal cord injury (SCI). BNI at St. Joseph’s Hospital and Medical Center is the largest dedicated neurosurgical center in the world and is a recognized leader in neurosurgical training, research, and patient care. More operative neurosurgical procedures take place at BNI than at any other institution in the United States. Nicholas Theodore, MD, Professor of Neurosurgery, Director of Neurosurgery Spine Program, and Director of Neurotrauma at BNI will be the study’s Principal Investigator.
Dr. Theodore said, “At present there are no effective therapies for the treatment of acute thoracic spinal cord injury. I am excited that InVivo’s Neuro-Spinal Scaffold will fill in the 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, not unlike a trellis for a growing plant, to help direct recovery of injured pathways.”
Dr. Theodore’s main focus is on complex spinal disorders and spinal cord injury. He is a published author in peer-reviewed journals and books, and has made over 100 technical presentations. He is the recipient of the Mayfield Award and the Tasker Award from the Congress of Neurological Surgeons, and was named a “U.S. News Top Doc.” Dr. Theodore recently received an NIH RO-1 grant to study spinal injuries and novel approaches to spinal surgery. Less than 10% of these grants are funded nationally. In 2014, Dr. Theodore was a recipient of a Department of Defense (DoD) grant to conduct a multi-center study evaluating cerebrospinal fluid drainage for the treatment of acute SCI. He, along with Dr. Neil Crawford, founded Excelsius Surgical, which focused on the development of image-guided robotic surgical techniques prior to its acquisition by Globus Medical, Inc.
“We are delighted to include the Barrow Neurological Institute in this study,” InVivo CEO Mark Perrin said today. “We are confident that our deep-rooted commitment to developing a treatment for patients who have acute SCI that may benefit from our innovation and scientific excellence will be carried forward by Dr. Theodore and his team, and by all of the clinical sites for whom enrollment is now open.”
The first clinical site, The University of Arizona Medical Center in Tucson, AZ, was approved in April of this year under the direction of Principal Investigator Ali A. Baaj, MD, Assistant Professor of Surgery and Director, Spinal Neurosurgery Program at The University of Arizona Medical Center.
A second clinical site, the Carolina Medical Center in Charlotte, NC, opened for enrollment in May of this year. Dom Coric, MD, of Carolina Neurosurgery & Spine Associates, Chief of Neurosurgery at Carolinas Medical Center, and William L. Bockenek, MD, head of Carolinas Rehabilitation, Charlotte, are Co-Principal Investigators.
This is the company’s first clinical study of its investigational 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 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 (HDE).
InVivo has pioneered a potential new treatment platform utilizing 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 Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function. There currently is no effective treatment for paralysis caused by SCI. The company estimates the worldwide market for treating acute complete SCI to be over $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 addressing a major unmet need for patients with SCI.
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and acts as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding the enrollment of additional patients in the scaffold pilot study following the reopening of enrollment and its ability to conduct a second pivotal study. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, as amended, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.