Evidence

Educated decision making with reasoned burden of proof requires access to relevant posters, abstracts and peer-reviewed publications

Evidence comes in many forms – with personal experience being the most credible. But before personal experience can be gathered, most bone graft materials must be evaluated under the regulation of the FDA. Tissue products (cellular bone matrices and simple allografts) are not required to provide any clinical proof of safety or performance to the FDA. Evidence supporting device products (formulated DBMs and synthetics) must compare favorably in animal studies to a similar bone graft material already on the market. A drug/device combination (peptide bone matrix and rhBMP) is proven in a human clinical trial.

Cerapedics believes that choosing a bone graft based on educated decision making with reasoned burden of proof requires access to relevant posters, abstracts and peer-reviewed publications. These are organized by our mechanism of action, pre-clinical research and clinical study.

IDE Study

i-FACTOR Bone Graft shown to be superior to autograft based on analysis of patient response to all four clinical endpoints from the pivotal IDE trial.

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Mechanism of Action

Key to choosing the appropriate graft material is an understanding of how it works. Learn more about the natural process and what to expect from i-FACTOR Bone Graft.

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Pre clinical

Studies have shown that P-15, in combination with ABM, mimics the behavior of autograft bone. Learn more about the depth of scientific research supporting this novel bone graft.

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Clinical

Research needs to translate into patient outcomes. Learn more about how i-FACTOR is transforming patients lives by providing clinicals with Level-1 data demonstrating the safety and efficacy of this new category of bone graft

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