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June 26, 2014
08:32 EDTNVIVInvivo announces BNI as third clinical trial site for neuro-spinal scaffold
InVivo Therapeutics Holdings announced that a third clinical site, the Barrow Neurological Institute, or BNI, in Phoenix, AZ, is now open for enrollment for patients with acute spinal cord injury. The first clinical site, The University of Arizona Medical Center in Tucson, AZ, was approved in April of this year under the direction of Principal Investigator Ali A. Baaj, MD, Assistant Professor of Surgery and Director, Spinal Neurosurgery Program at The University of Arizona Medical Center. A second clinical site, the Carolina Medical Center in Charlotte, NC, opened for enrollment in May of this year. Dom Coric, MD, of Carolina Neurosurgery & Spine Associates, Chief of Neurosurgery at Carolinas Medical Center, and William L. Bockenek, MD, head of Carolinas Rehabilitation, Charlotte, are Co-Principal Investigators. This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The pilot study has been approved by the FDAand is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
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December 16, 2014
08:01 EDTNVIVInvivo Therapeutics announces FDA approval to expedite pilot trial enrollment
InVivo Therapeutics Holdings announced approval by the U.S. FDA for an expedited enrollment plan for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment for the second subject in mid-January. Upon enrollment of the second subject, InVivo will submit to the FDA one month of safety data for that subject together with the previous subject’s data; concurrent enrollment for the remaining three subjects will then begin. There will be no additional mandatory holds between enrollment of the final three subjects. This differs from the previous plan, which required a mandatory three-month hold between sequential enrollment of each of the five subjects. This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The 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. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.

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