CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced a one-month post-implant update for the third study patient and a six-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 complete acute spinal cord injury.
In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.
The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.
The Neuro-Spinal Scaffold was implanted in both patients by Dr. Dom Coric of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center (CMC) in Charlotte, NC. The study is being led at CMC by Dr. Coric and Dr. William Bockenek, Chief Medical Officer of Carolinas Rehabilitation and Chairman of the Department of Physical Medicine and Rehabilitation at CMC.
Dr. Coric said, “I am very encouraged with the third patient’s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.” Dr. Bockenek further stated, “It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.”
Mark Perrin, InVivo’s CEO, said, “We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10-T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury. To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure. We look forward to continuing to follow these patients and expect to complete enrollment of the remaining two patients in our pilot trial within the coming months.”
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. 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 continued enrollment in our pilot trial 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 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.