CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced a six-month post-implant update for the first study patient and a three-month post-implant update for the second study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the first patient in October 2014 at the Barrow Neurological Institute, Phoenix, AZ and in the second patient in January 2015 at the Carolinas Medical Center, Charlotte, NC.
From the three-month assessment to the six-month assessment, the first patient has demonstrated continued improvement in motor function as assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. The patient has regained partial function of knee extensors and remains classified as ASIA Impairment Scale C (AIS C) with a motor incomplete spinal cord injury. The second patient remains classified as AIS A with a complete spinal cord injury. Of note is the appreciable improvement in the second patient’s trunk stability, self-care, mobility and bowel and bladder function at the three-month post-implant assessment. There have been no reported Adverse Events associated with the Neuro-Spinal Scaffold to date in either patient.
Dr. Lorianne Masuoka, InVivo’s Chief Medical Officer, added, “We would like to acknowledge the high level of care that our study patients are receiving by the neurosurgical and rehabilitation teams at the Barrow Neurological Institute and Carolinas Medical Center. The videos of our study patients posted on various social media outlets have proven both inspiring and scientifically valuable as we consider supplementing standard assessments with additional measures to identify motor improvement in trunk and hip muscles that are not evaluated as part of the standard ISNCSCI exam. We may add these assessments to the protocol of the ongoing pilot study or a future study to supplement the ISNCSCI exam.”
“I am very pleased with the improvements observed with the first two patients who have received our Neuro-Spinal Scaffold. The second patient’s progress is encouraging since the injury and the patient’s condition at presentation were more severe, delaying spinal stabilization, decompression, and scaffold implantation. We look forward to following the patients’ progress over the coming months and hope that they will demonstrate continued improvement,” said Mark Perrin, InVivo’s Chief Executive Officer and Chairman of the Board.
On March 26, the company announced the reopening of enrollment for the remaining three patients of its pilot trial in patients with acute thoracic spinal cord injury.
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot 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. 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 possible changes to the pilot trial protocol and the expected benefits, efficacy and future clinical outcomes of the company’s Neuro-Spinal Scaffold.. 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 volatility of the trading price of the company’s common stock; 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 FDA approval to modify its pilot trial protocol or to conduct a future study; 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, 2014, 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.