The peptide enhanced bone graft, i-FACTOR+ Matrix, from Westminster, Colorado-based Cerapedics, Inc. has received approval from Health Canada. Canada is the first market to approve the launch of the new bone graft. The bone graft uses the same string of amino acids, known as P-15, as the original i-FACTOR, but now it is bound to a collagen-based carrier for greater bioavailability and easier application. OTW recently covered the progress of the new material, also referred to as P15-L in a U.S. investigational device exemption (IDE) study named ASPIRE.
Cerapedics’ Next-Generation Graft Approved by Health Canada
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Cerapedics CEO Glen Kashuba described the improvements in the next-generation bone graft, “The matrix product leverages the clinically proven power of the P15 peptide combined with a collagen carrier for optimized interoperative delivery.” COO Jeffrey Marx, Ph.D. stated that the company anticipates “commercial launch in Canada this October.”
The active component of the bone graft, P-15, is a string of 15 amino acids normally found in Type I collagen. When bound to the matrix the peptide has significantly greater availability and activity than when buried in the tightly coiled collagen protein. The company’s oft repeated statement of “Attract, Attach, Activate,” refers to the compound’s ability to act upon bone building cells, including osteoblasts and progenitors, at the fusion site. Clinical studies have shown superiority to autograft and equivalence to bone morphogenetic protein-based biologics, without the undesirable side-effects associated with them. The first-generation bone graft, i-FACTOR, was FDA approved in 2015 for use in single-level anterior cervical discectomy and fusion (ACDF). It was approved for any bony defect of the spine or extremities in the European Union (EU) and Australia in 2008 and 2010, respectively.
The ASPIRE IDE trial began in 2018 and is expected to run for several more years with some initial results available in 2021, possibly enough to submit a pre-market approval application to the U.S. FDA.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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