CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that data from the Christopher & Dana Reeve Foundation NACTN Registry will be included in the Contemporary Thoracic SCI Registry Study (now called the “CONTEMPO Registry Study”), a complement to the ongoing INSPIRE study of the Neuro-Spinal Scaffold™. The CONTEMPO Registry Study is intended to provide comprehensive natural history benchmarks for INSPIRE study results that include spinal cord injury (SCI) patients with similar baseline characteristics treated since 2006. The NACTN registry is derived from a network of academic neurosurgical departments of hospitals that have a strong focus on SCI, especially in the acute injury phase. The NACTN Registry includes acute patient data such as pre- and post-operative data, post-injury complications and treatments, MRI data, and follow-up neurological exams. Because the NACTN registry contains acute care data, it will allow for the close matching of registry patient characteristics with INSPIRE inclusion and exclusion criteria, and will be highlighted in the CONTEMPO Registry Study as a well matched natural history benchmark comparator for INSPIRE results.
The CONTEMPO Registry Study will provide a robust evaluation of the recent natural history of acute, complete thoracic SCI patients across North American and European populations. InVivo has submitted a protocol for the CONTEMPO Registry Study to the U.S. Food and Drug Administration (FDA) and does not expect this study to affect clinical or regulatory timelines. InVivo believes that the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the Humanitarian Device Exemption (HDE) approval process, and plans to submit the two studies together for HDE approval.
James Guest, M.D., Ph.D., a member of InVivo’s Scientific Advisory Board, a NACTN investigator, and the Principal Investigator of the CONTEMPO Registry Study, said, “The NACTN Registry was developed in large part to aid in the interpretation of SCI clinical trial results. This is the first time that the registry will be used with a partner in industry, and I believe that the registry will provide a valuable benchmark for analysis of INSPIRE results.”
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are grateful for the care and vigilance that NACTN has put into developing an impressively thorough, curated database over many years. The inclusion of the NACTN Registry substantially increases the strength of the CONTEMPO Registry Study. We look forward to completing the INSPIRE study and the CONTEMPO Registry Study and submitting the results together in 2018 in an application for HDE approval of the Neuro-Spinal Scaffold.”
A new CEO’s Perspective discussing the CONTEMPO Registry Study can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. InVivo is in discussions with the FDA on this recommendation and believes that the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the HDE approval process. InVivo plans to submit the two studies together for HDE approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and carefully debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.
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.
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 HDE approval process, the expected impact of the Contemporary Thoracic SCI Cohort Study on clinical and regulatory timelines and the likelihood of demonstration of safety and probable benefit. 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 complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, 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 Quarterly Report of the three months ended March 31, 2017, 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.