Description

ST01 is a fully synthetic bone substitute material for lumbar, thoracic and cervical spinal fusion and related procedures. The product is based on the ceramic biomaterial ß-tricalcium phosphate (ß-TCP) coated with a recombinant human BMP variant.

ß-TCP is a synthetic calcium-based biomaterial which acts as a scaffold for new bone ingrowth. In spinal surgery, mechanical loading conditions are a major challenge for the biomechanical properties of new artificial bone substitutes. ß-TCP displays pressure-resistant characteristics and has scaffold properties for cell in-growth (osteoconduction). The BMP variant is a validated growth factor manufactured in E. Coli for effective bone augmentation in orthopaedic indications providing strong osteoinductive properties. The combination of rhBMP variant and ß-TCP provides ideal prerequisites for the use as bone substitute material in spinal fusion procedures.

The growth factor is applied to the granular ß-TCP scaffold using the proprietary coating technology. This proprietary coating technology allows for a homogeneous protein coating on the ß-TCP matrix while maintaining the biological activity of the growth factor, avoiding structural modifications as well as aggregation of the protein.

Highly promising preclinical data were obtained in a relevant rabbit model with ST01 showing superior efficacy compared to competitor products and autograft, in a posterolateral interbody spinal fusion model. Preliminary histological analysis suggests significant advantages in the formation of new bone mass, bone ripeness and bone stability.

The expected dose reduction and a controlled release formulation of the protein reduce the potential for harmful side effects and may prove more cost-effective.

ST01 therefore will have two significant advantages:

• Controlled release and reduced dosing of rhBMP variant with beneficial impact on the side effect profile (e.g., restriction of excessive bone growth)
• Compression-resistance (mechanical stress)

Developmental stage

ST01 has established proof-of-concept in a preclinical study that showed it was superior to the gold standard and competitor products in a spinal fusion model.

Further formulation for trauma/fractures

Scil Technology is developing an in situ forming scaffold targeted at fracture repair. The product consists of a protein-free matrix that is injected into the fracture region and hardens within a short time period at body temperature.