InVivo Therapeutics Holdings is a medical technology company focused on utilizing polymers as a platform technology to develop treatments to improve function in patients paralyzed as a result of traumatic spinal cord injury. In 2011, the company earned the prestigious David S. Apple Award from the American Spinal Injury Association for its contributions to spinal cord injury medicine.
The company today gave an update on the clinical timeline for its biopolymer scaffolding to treat acute spinal card injuries. InVivo’s management team now expects that it will enroll the first patient sometime in the first quarter of 2014. It anticipates that, from the date of the first patient enrollment, it will take a minimum of 21 months to complete enrollment.
This time is needed because of the conditions of the FDA approval of the Investigational Device Exemption. The five-person trial will be staggered so that each patient can be followed for three months prior to requesting approval to enroll the next patient. Consistent with FDA guidance, InVivo then expects to conduct a key study with a control group in order to obtain FDA approval to begin commercialization of its biopolymer platform under a Humanitarian Device Exemption.
In addition, the company’s new management team has begun a comprehensive project and timeline review of its hydrogel technologies platform as well as its application to pain treatment, dural sealants, nerve conduits, and fibrosis treatment. It plans to provide updates to the public as soon as possible on these programs.
For further information about InVivo Therapeutics Holdings, please visit www.invivotherapeutics.com
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