InVivo Therapeutics Holdings Corp. (NVIV) today announced it has
received written notification from the Securities and Exchange
Commission (SEC) that it has concluded its investigation of the Company,
which, as the Company previously disclosed, sought information
concerning statements related to the timing and completion of the
clinical study of the Neuro-Spinal Scaffold™. The SEC said that
it does not intend to recommend an enforcement action against the
Company.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151022005353/en/
Copyright Business Wire 2015