Our Products

ARTEBONE®

ARTEBONE® is obtained from demineralized reindeer bone using a process designed to retain a high and consistent level of bioactive osteopromotive growth factors. The tissue extract is added to the resorbable calcium salt granules andalso has osteoconductive properties. The product is being developed as a bone graft substitute for orthopedic applications, especially for challenging fracture and fusion cases where rapid and optimal bone regeneration is required. Our product provides the surgeon and patient with a safer, more reliable and better performing bone graft substitute for orthopedic surgery.

Safety

ARTEBONE® has been extensively evaluated in formal animal studies under GLP conditions normally reserved for new drugs or medicinal products, and the results so far have demonstrated a high degree of safety and no toxicity for this product. ARTEBONE® will be evaluated in a high quality study in humans to document the safety and performance features of the product.

Human DBM products are all derived from human donor bone and thus carry a risk of transmission of communicable disease whereas, ARTEBONE® is obtained from a natural wild animal source and is therefore incapable of transmitting a human disease pathogen like HIV, hepatitis B or C, or a Treponema pallidum organism.

The possible immunogenicity of the protein extract of reindeer origin has been tested in an extensive preclinical trial, without any alarming signs of reaction.

ARTEBONE® has been manufactured to medicinal product standards and has developed a full preclinical safety and toxicology package.

Reliability

Reliability means manufacturing consistency – not the lot to lot variability of osteopromotive growth factors in the product. Because the FDA requires that each lot of allograft or DBM product come from a single human donor, it is impossible to guarantee the same degree of quality from one batch to another. This problem cannot be solved by improvements in the bioprocessing; it is inherent in the source of the material. Independent analyses of current commercial DBM products have shown an unacceptably high lot-to-lot variability in concentration of many bone growth factors. In fact, many lots fail to contain any detectable levels at all for several of these growth factors. Only young healthy animals are procured for the manufacture of ARTEBONE® in order to guarantee a consistent and high level of growth factors. The manufacturing process has been designed to retain and concentrate all of the necessary factors originally present in the bone. Biochemical tests for specific growth factors have shown that these growth factors are present in much higher amounts in ARTEBONE® compared to human allograft and DBM products. The consistent and state-of –the art manufacturing process of ARTEBONE® far exceeds that of any comparable commercial product on the market.

Performance

Proven – Published Effectiveness

In multiple studies using rabbit and recently sheepsubjects, the reindeer bone morphogenic protein (BMP) has been shown to have osteopromotive healing properties at much lower doses than human-based pharmaceutical growth compounds. The reindeer BMP was shown to be safe and reliable as published in Acta Orthopaedica in 2006. BBS-Bioactive Bone Substitutes Ltd has proven its preclinical efficiency in several animal models.