Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) pilot trial of its neuro-spinal scaffolding is going extraordinarily well. The company is “2 for 2″ in respect of treating initially completely paralyzed patients to enable some motor function. In the coming months, it will enroll three more patients in the IDE pilot trial. The expectations are high from the ongoing trials. It started the pilot trial under a humanitarian based device pathway. The registration study is expected to commence next year. The stock price of Invivo has a meaningful run in the past six months.
In last week of March, the U.S. FDA approved to start the open enrollment of third, fourth and fifth patient in the company’s ongoing pilot trials of its investigational NSS for the treatment of acute SCI. It is primarily a safety study, with the main objective to assess whether the NSS is feasible and safe for curing complete functional spinal cord injury.
In the trial conducted by Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV), the primary endpoint is occurrence of all adverse device impact of any seriousness in six months post-surgery. The feature safety will be evaluated by no degradation in paralysis status or sensory motor neurological activity beyond that typically noticed in the AIS-A enrollment. However, to collect initial evidence of clinical efficiency of the NSS, investigators will evaluate functional progress of ASIA Impairment Scale, motor scores, sensory scores, bladder and bowel function, the Spinal Cord Independence Measure III and neurological tests.
Last October, Invivo completed the first surgery and implantation of NSS. The subject Jordan Fallis, was admitted at the Barrow Neurological Institute. In January, 2015 the company provided an update following a safety evaluation at 90 days post-surgery. The results were promising. Also, in between the implantation time and 90-day post-injury evaluation, no serious adverse effects linked with the NSS were recorded.