The study, published in Neurosurgery, the journal of the Congress of Neurological Surgeons, involved a 25-year-old man with an American Spinal Injury Assn. Grade A spinal cord injury sustained in a motocross accident. Dr. Nicholas Theodore, of the Johns Hopkins Neurosurgical Spine Center, implanted an InVivo spinal scaffold directly into the traumatic cavity.
After 3 months, the patient had improved to a Grade C incomplete injury, according to the study, and at 6 months there were no procedural complications or safety issues related to the device. InVivo has said that the patient demonstrated an 8-point gain on the 50-point AIS lower extremity motor score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.
“Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold,” according to the study.
“I am gratified that the case report detailing the safety and feasibility of the implantation of the neuro-spinal scaffold was published in a distinguished journal. The patient’s improvement to date has been notable and provides the basis for my continued enthusiasm for the Inspire study,” Theodore said in prepared remarks.
“We are very pleased to have the first clinical neuro-spinal scaffold case report published in a leading, peer-reviewed neurosurgical journal,” added InVivo chairman & CEO Mark Perrin. “We have been steadily increasing awareness in the neurosurgical community and look forward to additional publications on the Inspire study.”
In December 2015, InVivo won conditional approval from the FDA to convert its the ongoing pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. Earlier this year the company raised a $32 million funding round.