InVivo Therapeutics is now shipping its investigative Neuro-Spinal Scaffold, a sign that the device's clinical trial is approaching, albeit a year after the company received permission to test it in humans.
The University of Arizona Medical Center in Tucson will receive surgical training following the device's arrival and then begin subject enrollment, InVivo said in a statement. Two other sites have received institutional review board approval and will begin enrollment in the second quarter, the company said.
The trial will gather safety and effectiveness data in 5 patients with an acute thoracic spinal cord injury. Although InVivo received permission to test the scaffold in humans in April 2013, the FDA placed conditions over the form the trial should take, resulting in a delay in trial initiation and falling stock price.
The conditions of the investigational device exemption human clinical trial approval required it to enroll just one patient every three months. InVivo stock fell 40% when the news was announced in August 2013, and another 34% following the departure of its CFO. The stock now trades for less than $2 on the over-the-counter market. It has gone up about 30 cents on today's news.
CEO Mark Perrin has replaced Frank Reynolds, who resigned one week before the bad news about the company's delayed clinical trial. Steven McAllister is now the interim CFO.
According to an April 4 statement, the scaffold received a Humanitarian Use Device designation from the FDA, which is designed to speed the device's time to market because it treats a rare condition.
Following the safety trial, a larger pivotal study will be needed for final FDA approval. InVivo said that the global market for treating complete spinal cord injury patients is $500 million annually and treating chronic patients is $10 billion.
Still, there is much work to be done at InVivo. It posted a net loss of $38.7 million in 2013 according to the company's website.
- read the release
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