The Need

Today, a patient that requires a bone graft does not have an option that carries little risk or meets ideal graft criteria.  Although the ideal bone replacement involves the use of one’s own bone (autograft), the quantity that can be harvested is limited and the complications, which can sometimes be permanent, are significant and costly both to the patient (in terms of morbidity) and health care payor (direct medical costs).

The use of cadaver bone (allograft) eliminates the need for additional surgery for the patient, but also carries its own set of risks that include the induction of immune response, bone rejection, and/or transmission of virus through the implanted bone.  Thus the ideal bone graft material should be totally synthetic, non immunogenic, contain all the bone regenerative properties of an autograft, and be cost effective for all indications. Unfortunately, the majority of purely synthetic bone products only partially fulfill the ideal graft criteria.

Additionally, other technologies that use biologics generally have poor outcomes or limited efficacy due to the stability of the substrate, the enzyme and/or the ability to integrate proteins into the biomaterial during the bone replacement block manufacturing process.  The inability to confine the product to the bony area can lead to ectopic bone formation and sponge delivery is incapable of controlling dose levels.