CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) announced today that a second clinical site in its clinical study, the Carolinas Medical Center in Charlotte, NC, is now open for enrollment for patients with acute spinal cord injury (SCI). Dom Coric, MD, of Carolina Neurosurgery & Spine Associates, Chief of Neurosurgery at Carolinas Medical Center, is a Co-Principal Investigator. William L. Bockenek, MD, 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 Neuro-Spinal Scaffold 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). In commenting about the significance of this study, Dr. 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.”
InVivo has pioneered a 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 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. There is currently 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 the company’s business objective to address a major unmet need for patients with SCI.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials company with unique technologies for drug delivery 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 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 company’s expectations regarding enrollment of patients in the scaffold pilot study, its ability to conduct a second pivotal study, and the effectiveness of its scaffold and potential market for treatments of spinal cord injuries. 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; 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 its Form 10-Qs and its current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.
