– Continued Improvement from AIS B to AIS C for Two Patients with Early Conversions –
CAMBRIDGE, Mass. (June 28, 2017) – InVivo Therapeutics Holdings Corp. (NVIV) today announced that two patients in the INSPIRE study of the Neuro-Spinal Scaffold have improved from sensory incomplete AIS B spinal cord injury (SCI) to motor incomplete AIS C SCI in their most recent INSPIRE assessments. These are the second and third patients in the INSPIRE study to have reached AIS C motor incomplete classification.
One of these patients was enrolled in May 2016 and converted from complete AIS A SCI to incomplete AIS B SCI at the three-month exam in August 2016. At the 12-month visit, the patient regained motor function associated with the most sacral segments of the spinal cord and was assessed to be AIS C. Stuart Lee, M.D., is the Principal Investigator at Vidant Medical Center in Greenville, North Carolina, where this patient was implanted with the Neuro-Spinal Scaffold.
Dr. Lee said, “The patient’s continued improvement at the one year exam is encouraging. Return of sacral motor function may be related to improvements in bowel and bladder function that can have an appreciable impact on a patient’s quality of life. We look forward to monitoring this patient’s recovery and hope for continued progress.”
The second patient was enrolled in June 2015 and converted from complete AIS A SCI to incomplete AIS B SCI at the one-month exam in July 2015. At the 24-month per protocol ISNCSCI exam (see About the ISNCSCI Exam below), the patient was assessed to be AIS C with the ability to contract two muscles of one leg. The motor function was not noted in a separate medical evaluation earlier in the day that did not include a full ISNCSCI exam. Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, and William Bockenek, M.D., of Carolinas Rehabilitation, are Co-principal Investigators at the site where this patient was implanted.
Dr. Bockenek said, “This patient moved from AIS A to AIS B shortly after the initial injury and implantation with the Neuro-Spinal Scaffold two years ago, and now is noted on the ISNCSCI exam to have moved to an AIS C based on trace movements in one leg. Though the clinical significance of this change is unknown at this time, we remain cautiously optimistic that there may be a possibility for additional changes.”
InVivo CEO and Chairman Mark Perrin said, “We are excited that these two patients have continued to progress beyond the period of early improvement. Three of the five patients with an AIS conversion in INSPIRE have demonstrated motor recovery and are now classified as AIS C conversions. Having assessments of motor improvements occurring one or two years post-implantation is uncommon and may be indicative of prolonged neural repair.”
About the ISNCSCI Exam
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam is a full neurological exam designed to characterize a patient’s SCI, including full motor and sensory testing. Based upon the findings of the ISNCSCI exam, an American Spinal Injury Association Impairment Scale (“AIS”) grade classification is determined. For more information, refer to the ISNCSCI exam worksheet at: http://asia-spinalinjury.org/wp-content/uploads/2016/02/International_Stds_Diagram_Worksheet.pdf
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffoldwithin the decompressed and 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.
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 safety and effectiveness of the Neuro-Spinal Scaffold and the sufficiency of the INSPIRE study design to support application for an HDE. 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 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 on Form 10-Q for the quarter ended March 31, 2017, and its other filings with the SEC, including the company’s Annual Report on Form 10-K, its Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.