Invivo Therapeutics Holdings Corp(OTCMKTS:NVIV) has enrolled a second subject in its Study Of Pilot Spinal Cord Injury The objective of trial is to assess the feasibility and safety of the Neuro-Spinal Scaffold. Also, it will collect preliminary data of effectiveness. The treatment of the subject for SCI will be done at the Carolinas Medical Center. It is a key segment of the Carolinas HealthCare System.
The list of co-principal investigators includes Dr. Domagoj Coric and Dr. William Bockenek. Dr. Coric heads neurosurgery segment at Carolinas Medical Center while Dr. Bockenek is CMO of Carolinas Rehabilitation. Dr. Coric together with his associate Dr. John Ziewacz performed the second Neuro-Spinal Scaffold implant into a patient who suffered from acute spinal cord injury.
Both the Doctors are neurosurgery and spine associates with Carolina. Talking about implant, Dr. Coric said that the subject had a severe, multi-trauma injury due to which team has to wait for two days. They can move ahead with implantation surgery only after the subject was stable medically. The implantation was a success.
The safety data
Mark Perrin, the CEO of Invivo Therapeutics Holdings Corp(OTCMKTS:NVIV), said that the accident that results in a major spinal cord injury is tragic. The company is grateful to enroll the second subject in a short time after re-opening enrollment. Invivo is looking forward to monitor the subject progress. The FDA will require thirty days of safety data for the second subject compared to the original requirement of 90 days. Leaving any major safety issues, Invivo expects reopening the trial for concurrent enrollment of three subjects in about two months.
The ongoing trial is the first clinical study of Invivo’s Neuro-Spinal Scaffold. The IDE pilot study has received approval from the FDA. It plans to capture preliminary effectiveness and safety evidence of the study in five subjects suffering from acute thoracic spinal cord injury. Following the study, Invivo Therapeutics Holdings Corp(OTCMKTS:NVIV) expects to commence a pivotal trial to obtain FDA approval to begin commercialization under HDE.