In contrast, other categories of bone graft, for example synthetic bone grafts are characterized by passive processes where the results are highly subjective and dependent on a patient’s biology. On the other hand, DBMs claim to be osteoinductive, providing chemical materials to initiate bone formation. “However, the concentration of the proteins in the chemical materials is such that it makes inductivity in humans virtually impossible,” reveals Marx. More likely, cellular allograft materials appear to be dependent on the metabolic activity of living cells for their primary function and if that’s the case it would require an entirely different FDA pathway. “In short, it’s not certain what the value or mechanism of these products exactly is,” he adds.
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FREMONT, CA: Cerapedics, an ortho-biologics company, appoints Patrick O’Connor as the Vice President of clinical and market development. “We are pleased to welcome Mr. O’Connor to the Cerapedics team as we continue to enroll patients in our investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgery,” says Dr. Jeffery G. Marx, Ph.D., president and Chief Operating Officer of Cerapedics.