InVivo Therapeutics Holdings (NVIV) Gives Update on Clinical Timeline for Spinal Cord Injury Treatment

MissionIR would like to highlight InVivo Therapeutics Holdings (OTCBB: NVIV), a medical device company founded to develop and commercialize groundbreaking technologies for the treatment of spinal cord injuries (SCI). The company is dedicated to providing superior neurological products and services by delivering novel approaches to the treatment of disease that will improve the quality of life and satisfy the needs of those who live with spinal cord injury.

In the company’s news,

InVivo Therapeutics Holdings 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.  

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Forward-Looking Statement:

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