InVivo Therapeutics files an Investigational Device Exemption application with the FDA

InVivo Therapeutics Corporation has filed an Investigational Device Exemption application with the Food and Drug Administration 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.

CEO Frank Reynolds 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.

According to the Christopher Reeve Foundation website, there are “nearly 1 in 50 people living with paralysis -- approximately 6 million people.” Of this, 1,275,000 cases, or twenty-three percent, are the result of spinal cord injury.

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

By 2011, the total addressable market for acute spinal cord injury will be approximately $10.4B annually. The National Spinal Cord Injury Statistical Center (NSCISC) at the University of Alabama has been commissioned by the US government to maintain a national database of spinal cord injury statistics since 1973. The NSCISC has projected increasing incidence of annual spinal cord injuries due to a growing US population and escalated societal risks that include faster highway speed limits, expanding participation in extreme sports, and increased gun ownership.

The financial impact of a spinal cord injury, as reported by the NSCISC, is enormous. During the first year alone, “cost of care” ranges from $236,109 to $801,161, depending on the severity of the injury. The net present value (NPV) to maintain a quadriplegic for life who has been injured at age 25 is nearly $3.2 million, while the NPV to maintain a paraplegic for life is just over $1 million.

These costs place a tremendous financial burden on patients, families, hospitals, insurance providers, and government agencies. Moreover, despite the more than $24 billion spent annually to care for spinal cord injury patients, the patient remains disabled for life as current medical interventions address only the symptoms of spinal cord injury rather than the underlying neurological cause.

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