InVivo Therapeutics Hldgs Corp (fka NVIVQ)

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2nd Patient enrolled!

InVivo Therapeutics Announces Enrollment of Second Subject in Pilot Spinal Cord Injury Trial

InVivo Therapeutics Holdings (USOTC:NVIV)
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Today : Thursday 22 January 2015

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InVivo Therapeutics Holdings Corp. (NVIV) today announced that a second subject has been enrolled in the pilot study of its Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury (SCI) at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC. The objective of the pilot study is to evaluate the safety and feasibility of the Neuro-Spinal Scaffold as well as to gather preliminary evidence of effectiveness.

Dr. Domagoj Coric, Chief of Neurosurgery at Carolinas Medical Center, together with Dr. William Bockenek, Chief Medical Officer of Carolinas Rehabilitation, are Co-Principal Investigators at this site. Dr. Coric and his partner Dr. John Ziewacz, both of the Carolina Neurosurgery and Spine Associates, performed the second-ever Neuro-Spinal Scaffold implant into an acute spinal cord injury patient. Dr. Coric commented, “This subject sustained a severe, multi-trauma injury that required my team to wait two days for the subject to stabilize medically before proceeding with the concurrent spinal stabilization and implantation surgery. The implantation procedure was a success, and I look forward to monitoring the subject’s progress.”

Mark Perrin, InVivo’s CEO, said, “Although each accident that results in a spinal cord injury is tragic, we’re grateful to have enrolled the second subject so quickly after re-opening enrollment, and are looking forward to monitoring the subject’s progress. As previously stated, the FDA will require only 30 days of safety data for this subject, rather than the original requirement of 90 days, before reopening enrollment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrollment of subjects three through five in about two months.”

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (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 (HDE).

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110