The first human trial to evaluate a biopolymer scaffold product for traumatic spinal cord injury is all set to be initiated in the next few months by InVivo Therapeutics Holdings Corp. (NVIV).
The FDA approved the company's Investigational Device Exemption, seeking permission to begin human studies to test its biopolymer scaffolding for the treatment of acute spinal cord injury, today.
The company plans to finalize the details of the study over the next month or so, and expects to have all data to the FDA by the end of 2014. The study is expected to occur over approximately 15 months.
In non-human primate studies involving monkeys and rodents with spinal cord injury, treatment with InVivo's biopolymer scaffolding has demonstrated functional recovery.
According to the National Spinal Cord Injury Statistical Center, the annual incidence of spinal cord injury (SCI), not including those who die at the scene of the accident, is about 40 cases per million population in the U. S. or approximately 12,000 new cases each year. Currently, there are no treatment options to successfully restore function following a spinal cord injury.
InVivo's biopolymer scaffolding product has also received Humanitarian Use Device, or HUD, designation. Devices that receive HUD designation are developed to treat rare, 'orphan' diseases or conditions. HUD designation also speeds up the regulatory process.
In his own words in a press release issued yesterday, this is what Frank Reynolds, InVivo CEO said, " We intend to leverage our platform to further develop treatments for chronic SCI, and expect 2013 to be a springboard year for our stakeholders as we have multiple 510(k) products targeted for market entry by the end of 2014. Our work in 2013 will be marked by clinical SCI data and by developing treatments for additional neurotrauma conditions in the arms and legs while we engage the FDA on multiple products."
Shares of InVivo Therapeutics, which trade on over the counter Bulletin Board, have thus far hit a 52-week low of $1.25 and a 52-week high of $2.94.
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