News 2014

InVivo announces FDA approval to expedite enrolment for ongoing pilot trial

Published: December 17, 2014

(Spinal News International) InVivo Therapeutics has announced approval from the US Food and Drug Administration (FDA) for an expedited enrolment plan for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.

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InVivo Therapeutics Given Go-Ahead to Expedite Enrollment in Neuro-Spinal Scaffold Trial

Published: December 16, 2014

FDA News Device Daily Bulletin The FDA has given a green light to expedited enrollment in InVivo Therapeutics’ ongoing clinical trial of the Neuro-Spinal Scaffold in patients with acute spinal cord injury, the company said Tuesday. The five-subject pilot study will capture preliminary safety and efficacy data in support of a larger pivotal study and humanitarian device exemption submission.

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First Patient Implanted With InVivo’s Spinal Scaffold

Published: October 16, 2014

FDA News Device Daily Bulletin InVivo Therapeutics said Tuesday it has enrolled the first patient in a pilot study of the Neuro-Spinal Scaffold. The device is being evaluated as a treatment for complete traumatic spinal cord injuries. The study — conducted at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz. — will gauge the safety and preliminary efficacy of the scaffold, determined by no worsening of paralysis or sensory motor neurological function, the company said.

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