CAMBRIDGE, Mass., Oct 23, 2015 (BUSINESS WIRE) — InVivo Therapeutics Holdings Corp. (NVIV) today announced a 12-month post-implant update for the first 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 the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors.
A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.
“I am delighted that our first patient continued to experience significant motor improvement after the 6-month visit. It is particularly exciting that the patient is regaining motor function in the ankle region as this indicates recovery is occurring not only in muscles that demonstrated some early recovery, but also in new muscles further down the legs. We are all hoping for continued improvement for the patient in the future. It was a brave decision to volunteer to be the first person ever to receive our investigational product, and it has been rewarding to observe the patient’s steady improvement over the last year,” said Mark Perrin, InVivo’s CEO and Chairman.
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.