CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Cooper Neurological Institute (CNI) in Camden, NJ has been added as a clinical site in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). CNI is a part of Cooper University Health Care, a network providing care to Southern New Jersey and the entire Delaware Valley. Steven Yocom, DO, Assistant Professor of Neurosurgery and Co-Director of the CNI Spine Program, has been named Principal Investigator at this site.
“Our group has a particular interest in spinal trauma and spinal cord injury. I’m excited that InVivo is approaching the significant unmet medical need in this field with such a novel technology,” Dr. Yocom said.
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Yocom and the Cooper Neurological Institute to our study. Dr. Yocom’s subject matter expertise will be valuable as we seek to enroll the final two subjects in our ongoing pilot trial.”
There are currently 13 clinical sites that are open for enrollment:
- Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
- Barrow Neurological Institute – St. Joseph’s Hospital and Medical Center, Phoenix, AZ
- Carolina Neurosurgery and Spine Associates/ Carolinas Rehabilitation, Charlotte, NC
- Cooper Neurological Institute, Camden, NJ
- Goodman Campbell Brain and Spine / Indiana University Health Neuroscience Center, Indianapolis, IN
- Keck Hospital of University of Southern California, Los Angeles, CA
- Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
- Oregon Health & Science University, Portland, OR
- Rutgers New Jersey Medical School, Newark, NJ
- University of Arizona Medical Center, Tucson, AZ
- University of California/Davis Medical Center, Sacramento, CA
- University of Kansas Medical Center, Kansas City, KS
- University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the 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. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
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 is designed to act 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 (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage 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, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., 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. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
About the Cooper Neurological Institute
The Cooper Neurological Institute (CNI) is fully dedicated to the diagnosis and treatment of neurological and neurosurgical issues. The Institute offers convenient access to CNI’s nationally-recognized team of physicians including specialists in minimally invasive neurosurgery techniques, brain tumor treatments, spinal trauma, hydrocephalus, neuromuscular care. Our Stroke Program is certified as a Primary Stroke Center by the Joint Commission. At the CNI, patients are offered supportive services including support groups, integrative medicine, nutritional and psychological counseling, and social services.
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," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the company’s ability to conduct a 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 volatility of the trading price of the company’s common stock; 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 modify its pilot trial protocol or to conduct a future study; the company’s ability 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 the treatment of 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, 2014, 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.
