The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“I am delighted that our first patient continued to experience significant motor improvement after the 6-month visit. It is particularly exciting that the patient is regaining motor function in the ankle region as this indicates recovery is occurring not only in muscles that demonstrated some early recovery, but also in new muscles further down the legs. We are all hoping for continued improvement for the patient in the future. It was a brave decision to volunteer to be the 1st person ever to receive our investigational product, and it has been rewarding to observe the patient’s steady improvement over the last year,” CEO Mark Perrin said in a press release.
Between the 6-month and 12-month follow ups, InVivo said the patient demonstrated an 8-point gain on the American Spinal Injury Association’s 50-point lower extremity motor score and additional bilateral motor function improvements.
Comparable patients with similar injuries not treated by the device showed an average improvement of less than 2 points, the company said.
The company said the patient also showed bilateral contractions of the ankle dorsiflexors and plantar flexors for the 1st time.
Earlier this month, InVivo said it won a nod from the FDA to double the enrollment in a clinical trial of its neuro-spinal scaffold.
Cambridge, Mass.-based InVivo enrolled the 5th patient in the pilot study last month. Its bioabsorbable device is designed to treat acute spinal cord injuries.
The FDA approved the expansion of enrollment in the pilot study from 5 to 10 patients. InVivo said it plans to transition the pilot study into a pivotal probable benefit trial and use it as the basis for a bid for humanitarian device exemption from the U.S. safety watchdog.