Here are five key notes:
1. The most recent patient is the seventh out of 11 patients who reported an AIS grade improvement at the one-month follow-up after the procedure. The trial's conversion rate is currently 63.6 percent. The patient improved from AIS A to AIS B spinal cord injury between the one- and two-month evaluations.
2. The trial includes two other patients who haven't had their one-month visit yet, but the conversion rate is already higher than published rates for other SCI treatments, which is below 25 percent.
3. In addition to AIS conversion, the patient reported substantial improvement in sensory and motor function; before surgery the patient had T12 neurological level of injury with some spared bilateral sensation at the front of the legs and unilateral palpable hip muscle contraction but couldn't move the legs.
However, two months after treatment the patient could move his hips and knees bilaterally and regained some sensory function in almost all regions of the lower back, feet and back of the body below the waist.
4. The Neurovascular Program Director and Principal Investigator at Banner-University Medical Center in Tucson Travis Dumont, MD, performed the patient's procedure and has been following his recovery.
"This patient had a very low thoracic neurological level of injury, and such patients have the best prognosis," he said. "Nonetheless, I have been impressed with the patient's recovery to date and am hopeful that the positive trajectory will continue."
5. The Neuro-Spinal Scaffold implant is an investigational device that received the Humanitarian Use Device designation for use in the Inspire pivotal probable benefit study.
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