CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced the University of Pittsburgh Medical Center (UPMC) Presbyterian in Pittsburgh, PA as a clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). UPMC is the largest non-governmental employer in Pennsylvania (with more than 62,000 employees) and operates more than 20 academic, community, and specialty hospitals and 400 outpatient sites. David Okonkwo, MD, PhD, is the Director of Neurotrauma and Director of Scoliosis and Spinal Deformity at UPMC Presbyterian and Associate Professor of Neurological Surgery and Clinical Director of the Brain Trauma Research Center at the University of Pittsburgh. Dr. Okonkwo will be the study’s Principal Investigator at that site.
“We have been searching for decades for an option for patients with these challenging injuries,” Dr. Okonkwo said. “The InVivo study is a unique, never-before tried intervention for spinal cord injury. I’m excited to see if it will prove to be a new way of treating thoracic spinal cord injuries.”
On October 15, 2014, InVivo announced enrollment of its first patient in the study at its clinical site, Barrow Neurological Institute in Phoenix, Arizona. Mark Perrin, InVivo’s CEO, said, “We’re very pleased to have Dr. Okonkwo and UPMC Presbyterian join our pilot trial. Dr. Okonkwo is a thought leader in this area and UPMC is a center of excellence in treating spinal cord injury patients and it is an honor to have them on board. We now have six sites that will be ready to enroll patients once we re-open enrollment.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE 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).
For more information, please visit the Company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold
The biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure 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 safety, feasibility, and clinical effectiveness of its scaffold device, 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.
