InVivo Announces Enrollment Of Fourth Patient In Pilot Spinal Cord Injury Trial

(RTTNews) - InVivo Therapeutics Holdings Corp. (NVIV) announced that a fourth patient has been enrolled in the company'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, CA.

Kee Kim, M.D., Principal Investigator at this site, performed the fourth-ever Neuro-Spinal Scaffold implantation approximately 53 hours after the injury occurred, the company noted.

This is the company's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption or 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.

Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption or HDE.