August 17, 2016
CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the ninth patient implanted with the Neuro-Spinal Scaffold™ in the INSPIRE study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between the two- and three-month evaluations. This is the fifth out of the eight patients (62.5% conversion rate) in follow-up to have had an AIS grade improvement to date. 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.* Historical conversion rates are lowest for patients with high thoracic (T2-T5) injuries, with fewer than 8% of patients converting by six months post-injury. The neurological level of injury for this patient was T4.
“The evidence obtained to date in the INSPIRE study is tremendously encouraging. It has been rewarding to be involved in the study and to observe this patient’s recovery to date, and I hope that the patient continues to make progress,” said Stuart Lee, M.D. Dr. Lee, Principal Investigator at Vidant Medical Center in Greenville, NC performed the ninth patient implantation procedure.
“Having five patients improve AIS grades so early in the INSPIRE study is a fantastic achievement and a major milestone for InVivo,” said Mark Perrin, Chief Executive Officer and Chairman. “If we continue to observe AIS conversions at a similar rate, we will dramatically exceed the Objective Performance Criterion (OPC) measure of study success. Our current conversion rate is four times the rate in natural history databases, which is extremely encouraging. We look forward to completing the INSPIRE study as quickly as possible and applying for an HDE in 2017.”
The OPC measure of success for the INSPIRE study is defined as five (25%) or more of 20 evaluable patients in the study having improved by at least one AIS grade at the six months post-implantation assessment. If all five converted patients to date do not revert to AIS A before reaching the six month assessment and are deemed evaluable at the end of the study, then the OPC will have been met.
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. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a HDE application for marketing approval. For more information, refer tohttps://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 pivotal probable benefit 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 Scaffoldreceived 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, the potential achievement of OPC, the determination of whether patients are deemed evaluable and the expectation for 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 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)
InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535