CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced a six-month post-implant update for the fifth patient in 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.
All patients enrolled in The INSPIRE Study have complete (AIS A) injuries at the time of enrollment. In the time between the three-month and the six-month post-injury assessment, the fifth patient treated improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The ASIA Impairment Scale (AIS) is a five grade scale (AIS A-E) that measures the severity of a spinal cord injury.
The primary endpoint of The INSPIRE Study is the proportion of patients with an improvement in AIS grade by the six-month visit. So far, three out of the first five patients treated (60%) have had an AIS grade improvement by 6 months. Several large natural history databases indicate that fewer than 16% of patients with complete thoracic injuries have an AIS grade improvement by six months post injury.*
As previously announced, the Objective Performance Criterion (OPC) measure of study success for The INSPIRE Study is defined as 25% or more of the patients improving by at least one AIS grade by six months post-implantation.
Mark Perrin, Chief Executive Officer and Chairman, said, “We are encouraged to see this patient’s significant neurological progress. This third conversion brings us one step closer to achieving the Objective Performance Criterion (OPC) for The INSPIRE Study. Our goal is to approach full enrollment of the pivotal INSPIRE study by the end of the year, which will allow for an HDE (Humanitarian Device Exemption) submission in 2017.”
About The INSPIRE Study
The INSPIRE Study 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 study is expected to enroll 20 patients. 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 debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across 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.
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, progress toward achievement of OPC for The INSPIRE Study, the expected timing of full enrollment in the study, and the timing of the submission for Humanitarian Device Exemption (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 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, 2015, 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.
* Zariffa et al., Spinal Cord (2011); Lee et al., J. Spinal Cord Med. (2014); Fawcett et al., Spinal Cord (2007)