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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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April 1, 2015
08:03 EDTNVIVInvivo Therapeutics announces new trial site for neuro-spinal scaffold
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March 30, 2015
08:06 EDTNVIVInvivo Therapeutics announcse new site for neuro-spinal scaffold clinical trial
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March 26, 2015
09:03 EDTNVIVInvivo reports reopening of enrollment in neuro-spinal scaffold trial
InVivo Therapeutics Holdings announced the reopening of subject enrollment for the company’s ongoing Investigational Device Exemption pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrollment of each subject. To date, there have been no reported serious safety events related to the Neuro-Spinal Scaffold or the procedure to implant the Neuro-Spinal Scaffold with the study’s first and second subjects, and InVivo has been approved by FDA and the Data Safety Monitoring Board to move forward with the study. As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial. 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.
March 24, 2015
08:01 EDTNVIVInvivo Therapeutics announces 1-for-4 reverse stock split
InVivo Therapeutics Holdings announced that its Board of Directors has approved a 1-for-4 reverse stock split of its issued and outstanding common stock in preparation for its planned uplisting to the NASDAQ Capital Market. The company anticipates the reverse stock split to become effective and its common stock to begin trading on a post-split basis at the open of trading on April 8, contingent upon approval from the Financial Industry Regulatory Authority. The reverse stock split is intended to fulfill InVivo’s requirements for listing to the NASDAQ Capital Market since the requirements include that a company’s common stock must maintain a minimum closing price of $3.00 for at least five trading days.

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