The Cambridge, Mass.-based company won FDA approval to launch the new pivotal study of the device last March, after ending the previous Inspire study of the device in January.
InVivo’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
In its new 20-patient, two-arm, randomized, controlled study InVivo aims to explore the usefulness of its neuro-spinal scaffold device in treating patients with complete thoracic AIS A spinal cord injuries.
The study’s primary endpoint will be the difference in the proportion of subjects who demonstrate an improvement of at least one grade on the AIS scale at a six-month follow-up visit, calculated between the treatment and control arm. The company said it will be looking for an effect equal to or greater than 20%.
“Having the first two patients enrolled into the INSPIRE 2.0 Study is a critical milestone for the company and for the spinal cord injury patient population, as there continues to be inadequate treatment options for these patients. With eight clinical sites now open for enrollment, we remain optimistic about continuing to execute on the INSPIRE 2.0 study and will provide updates when appropriate. We appreciate the investigators’ continued focus and willingness to support not only this trial, but also this underserved patient population. Ultimately, we hope to address a large unmet medical need for spinal cord injury patients,” prez & CEO Dr. Richard Toselli said in a press release.