InVivo Therapeutics Reports Conversion of a Fourth Patient Implanted with the Neuro-Spinal Scaffold(TM) in the INSPIRE Study
- April 26th, 2016
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- Four Out of First Six Patients Have Converted from Complete to Incomplete Spinal Cord Injury –
CAMBRIDGE, Mass. / CRWEPRESSRELEASE / April 26, 2016 – InVivo Therapeutics Holdings Corp. (NVIV) today announced that the sixth-implanted patient in the INSPIRE study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This is the fourth out of the first six patients (67%) with at least two months of follow up data to have had an AIS grade improvement.
The Objective Performance Criterion (OPC), a measure of study success for the INSPIRE study, is defined as 25% or more of the patients having improved by at least one AIS grade by six months post-implantation. 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. *
“We’re encouraged by the progress the patient has made in the first two months after injury. It’s still early in the patient’s recovery period, and we look forward to monitoring this patient for signs of further neurological recovery,” said Wilson (Zack) Ray, M.D. Dr. Ray performed the implantation at the Barnes-Jewish Hospital at Washington University Medical Center in St. Louis, MO.
“The proportion of patients in the INSPIRE study that have recovered some neurological function is impressive. This most recent conversion brings us closer to achieving the study’s Objective Performance Criterion of five patient conversions. We will be enrolling 13 additional evaluable patients in order to reach 20 patients at six months, and we only need to observe one additional conversion in order to meet the OPC,” said Mark Perrin, InVivo’s Chief Executive Officer and Chairman. “Our goal is to approach full enrollment by the end of this year and file for Humanitarian Device Exemption approval next year.”
All patients enrolled in the INSPIRE study have complete (AIS A) spinal cord injuries at the time of enrollment. In the time between the one-month and the two-month post-injury assessment, the sixth 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.
* Zariffa et al., Spinal Cord (2011); Lee et al., J. Spinal Cord Med. (2014); Fawcett et al., Spinal Cord (2007)
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. 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 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 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 of the 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 impact of achieving the OPC on the FDA approval 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.
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