Fourth Patient Enrolled in InVivo Therapeutics' Pilot Spinal Cord Injury Trial.
M2 PHARMA-August 20, 2015-Fourth Patient Enrolled in InVivo Therapeutics' Pilot Spinal Cord Injury Trial
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A fourth patient has been enrolled in US-based medical device maker InVivo Therapeutics Holdings Corp.'s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute thoracic spinal cord injury at the UC Davis Medical Center in Sacramento, California, the company said on Thursday.
Kee Kim, M.D., Principal Investigator at this site, performed the fourth-ever Neuro-Spinal Scaffold implantation approximately 53 hours after the injury occurred.
This is the company's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption 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.
Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
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 designation and is currently being studied in an Investigational Device Exemption pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
InVivo Therapeutics Holdings 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.
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|Date:||Aug 20, 2015|
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