Aiming to promote neural regeneration after spinal cord injury
Caution: Investigational device. Limited by federal law to investigational use.
Our investigational Neuro-Spinal Scaffold™ is implanted at the site of damage within one week of spinal cord injury with the goal of supporting neural regeneration and cell growth.
If left untreated, a cavity will typically develop at the injury site, cutting off transmission of neural signals from the brain to all body parts below the injury. The scaffold is designed to encourage functional cells to fill in that cavity. If achieved, this structural change within the spinal cord has the potential to improve sensory and motor function and lead to a better quality of life for patients.
Our investigational Neuro-Spinal ScaffoldTM
Our proprietary and investigational Neuro-Spinal Scaffold technology is composed of two biocompatible and bioresorbable polymers which together form a highly porous framework that is conducive to cellular attachment and growth.
The scaffold is surgically implanted into the gap in the spinal column that arises at the site of injury, aiming to create a neuropermissive matrix that allows cells which are critical to neuronal health to respond to the injury site and begin filling the cavity. The scaffold breaks down in the body over several weeks and is resorbed.
How the scaffold is designed to facilitate recovery
If achieved, a robust response can lead to improved outcomes for spinal cord injury patients by:
Visualizing improvement in an animal model
The architecture of the spinal cord has not been restored to pre-injury status. However, the cyst is now filled with a neuropermissive matrix that allows cells, which are critical to neuronal health, to respond to the injury site and begin filling the cavity.
Existing Clinical Results
In its first human clinical study (INSPIRE 1.0), the Neuro-Spinal Scaffold was studied in 19 patients with acute thoracic spinal cord injury.
For more information on our clinical data, please see our corporate deck here.
Strong support in scientific literature
Aimetti A.A., et al ,"Natural history of neurological improvement following complete (AIS A) thoracic spinal cord injury across three registries to guide acute clinical trial design and interpretation", Spinal Cord (2019): 753-762 | 2019
Guest, J.D. et al ,"Internal decompression of the acutely contused spinal cord: Differential effects of irrigation only versus biodegradable scaffold implantation.", Biomaterials (2018) | 2018
Layer RT, Ulich TR, Coric D, Arnold PM, Guest JD, Heary RH, Hsieh PC, Jenkins AL, Kim KD, Lee KS, Masuoka LK, Neff KM, Ray WZ, Theodore N, Fehlings MG ,"New clinical-pathological classification of intraspinal injury following traumatic acute complete thoracic spinal cord injury: postdurotomy/myelotomy observations from the INSPIRE trial", Neurosurgery | 2017 | 2017
Dukes, Ellen M., et al ,"Relationship of American Spinal Injury Association Impairment Scale Grade to Post-injury Hospitalization and Costs in Thoracic Spinal Cord Injury", Neurosurgery | 2017
Slotkin, John R., et al ,"Biodegradable scaffolds promote tissue remodeling and functional improvement in non-human primates with acute spinal cord injury", Biomaterials Apr 2017: 63-76 | 2017
Theodore, N. et al ,"First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury: A clinical pilot study for safety and feasibility.", Neurosurgery (2016) | 2016
Pritchard, Christopher D., et al ,"Establishing a model spinal cord injury in the African green monkey for the preclinical evaluation of biodegradable polymer scaffolds seeded with human neural stem cells", Journal of Neuroscience Methods 188.2 (2010): 258-269 | 2010
Teng, Yang D., et al ,"Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells.", Proceedings of the National Academy of Sciences 99.5 (2002): 3024-3029 | 2002