Degenerative disc disease is a gradual process by which the inter-vertebral discs lose their ability to act as effective ‘shock absorbers’ and become less flexible. Degenerative disc disease is primarily an age-related disease, but can also be a result of major injury to the spine. It afflicts nearly half the US population between forty and sixty years of age and approximately 90% of Americans older than sixty. [1]

In its most advanced stages, disc degeneration may ultimately be followed by collapse, resulting in excruciating pain. In cases of degeneration leading to collapse (most frequent in discs in the cervical or lumbar region) debilitating pain, impairment of neurological function, and, in the most acute cases, paralysis may result from the instability of vertebrae interfering with the function of surrounding nerves. [1]

Patients who fail to experience improvement with bed rest and anti-inflammatory medications are often diagnosed with a herniated disc. Treatment for this indication may involve discectomy, or fusion of affected vertebral bodies if the spine is unstable. Fusion procedures are designed to eliminate motion between the affected vertebrae, thus providing pain relief at the site of spinal instability. The vertebrae are fused using bone grafts, with or without pedicle screws, plates, or cages. [1]

In these cases, bone grafts provide osteoconductive scaffolds for local natural bone growth and more rapid fusion results. Bone graft material may be placed directly into the inter vertebral gap formerly occupied by the defunct disc or into the centre of a threaded titanium fusion cage, allograft bone dowel, or femoral ring to induce bone growth into, around and through the structure replacing the disc. [1]

Scil Technology is developing ST01, an artificial bone substitute material for lumbar, thoracic and cervical spinal fusion and related procedures. The product is based on a ceramic biomaterial ß-tricalcium phosphate (ß-TCP) coated with a recombinant human BMP variant. In spinal surgery, mechanical loading conditions are a major challenge for the biomechanical properties of new artificial bone substitutes. ß-TCP displays compression-resistant characteristics and has scaffold properties for cell in-growth (osteoconduction). The BMP variant encourages this osteoconduction allowing for spinal fusion composed of living bone. The combination of the growth factor and ß-TCP in ST01 therefore provides ideal prerequisites for use as bone substitute material in spinal fusion procedures.

ST01 has established proof-of-concept in a preclinical study showing superiority to the gold standard and competitor products in a spinal fusion model.

[1] Market Dynamics: Bone Substitutes and Growth Factors; Datamonitor, December 2002