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InVivo Therapeutics Files Investigational Device Exemption Application With FDA

To advance human clinical studies for spinal cord injury treatment

InVivo Therapeutics has filed an investigational device exemption application with the FDA requesting permission to advance to human clinical studies. InVivo is currently conducting its third primate study and expects to receive approval to begin a human study in 2010.

Frank Reynolds, CEO is confident in the company’s chances of receiving approval, and is optimistic about what obtaining a regulatory green light represents for spinal cord injury research, making InVivo’s technology the first treatment of its kind to progress to clinical studies.

Reynolds, said: “We anticipate annual revenue for our first product to exceed a billion dollars. The total market opportunity is significant.”

“As a spinal cord injury patient myself, I keep our team focused on a daily basis. Our organization looks forward to providing humanitarian benefit to the millions of people waiting for us to succeed.”