InVivo Therapeutics Corporation Reports Three-Month Update Of First Acute Spinal Cord Injury Subject Implanted With Neuro-Spinal Scaffold

- Motor, Sensory, Bowel, and Bladder Function Improvement with No Reported Serious Adverse Events -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced a three-month update for the first subject in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in subjects with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the subject on October 14, 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, AZ by Dr. Nicholas Theodore, Chief of Spinal Surgery.

“We are impressed with the first subject’s progress to date since comparable spontaneous recovery occurs infrequently in patients with similar injuries. We look forward to continuing to evaluate the Neuro-Spinal Scaffold in this first subject and the remaining subjects planned for this study.”

In the time between implantation and the 3-month post-injury assessment, there were no reported serious adverse events associated with the Neuro-Spinal Scaffold and the subject had progressed from a complete AIS A injury to an incomplete AIS C injury with motor, sensory, bowel, and bladder function improvements. Motor improvement from the pre-surgery assessment to the 3-month visit involved the return of active movement of the hip flexors against gravity (allowing for leg to chest motions) and palpable contractions of the knee extensors. Sensory improvement from the pre-surgery assessment to the 3-month visit involved the bilateral return of sensation to two dermatomes extending down the top of the subject’s legs and the S4-S5 dermatome. In addition, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam, the Spinal Cord Independence Measure (SCIM III) exam, and additional assessments of bowel and bladder function demonstrated that between hospital discharge and the 3-month visit, the subject has regained bowel function and improved bladder function.

Dr. Theodore said, “I am very pleased with the first subject’s progress since the scaffold was implanted. In my experience, this degree of sensory and motor improvement is unexpected. However, this is only one patient and we do not want to over-interpret the data.”

Mark Perrin, InVivo’s CEO, said, “We are impressed with the first subject’s progress to date since comparable spontaneous recovery occurs infrequently in patients with similar injuries. We look forward to continuing to evaluate the Neuro-Spinal Scaffold in this first subject and the remaining subjects planned for this study.”

The data from the first subject were obtained and calculated in accordance with the ISNCSCI, the standard examination used to determine motor and sensory impairment and severity of a spinal cord injury. A copy of the ISNCSCI exam worksheet can be found on the American Spinal Injury Association (ASIA) website at http://www.asia-spinalinjury.org/elearning/ISNCSCI.php.

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. As previously announced, the company has reopened the trial for enrollment of its second subject. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

About the Neuro-Spinal Scaffold

The biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a pioneering 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, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, 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" and similar expressions, and include statements regarding the company’s ability to enroll additional patients in the pilot trial; the degree of improvement in the first subject after implantation of the Scaffold compared to other patients; and the company’s ability to conduct a second pivotal study. 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 FDA approval 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 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, 2013, as amended, 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.