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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.
News For NVIV From The Last 14 Days
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November 25, 2014
08:04 EDTNVIVInvivo Therapeutics announces UPMC as clinical side in IDE pilot study
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November 21, 2014
08:02 EDTNVIVInvivo Therapeutics names fifth clinical site for neuro-spinal scoffold study
InVivo Therapeutics Holdings announced that the Oregon Health & Science University in Portland, OR is the fifth clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury. OHSU is a nationally prominent research university and Oregon’s only public academic health center, seeing nearly one million patients every year. Ahmed Raslan, MD, an Assistant Professor of Neurological Surgery at OHSU, will be the study’s Principal Investigator at that site. On October 15, InVivo announced enrollment of its first patient at Barrow Neurological Institute in Phoenix, Arizona. Mark Perrin, InVivo’s CEO, said, “We continue to bring great centers into our study and are delighted to have Dr. Raslan and OHSU join us. OHSU and the other centers will be able to enroll the next subject following the three-month observation period for first patient.” 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 U.S. 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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