The leaders of Cerapedics, Inc. think the FDA is on the verge of approving a Premarket Approval (PMA) application for the company’s i-Factor peptide enhanced bone graft.
No FDA Panel Required for Cerapedics PMA Application
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Secondary
The company announced on June 16, 2015 that it has been informed that the agency will not need to convene an advisory panel to review the company’s application and make a decision about approving the product or issuing a non-approvable letter.
Jeff Marx, Ph.D., the company’s president and COO, is happy about the news. He said he was “pleased” about moving forward without a panel meeting. “We appreciate the interactive nature of the FDA review process, which has streamlined our application, ” said Marx.
Glen Kashuba, the company’s CEO, said, “Leading with this excellent clinical profile and what we believe will become the only biologic bone graft approved for cervical fusion, we think that i-FACTOR bone graft will be an important product for patients and clinicians. We are excited to be advancing i-FACTOR bone graft through the regulatory process and are now shifting our focus toward planning for U.S. commercialization.” We would like to thank all of our clinical investigators and other contributors. Without their efforts, we would not be in this position today.”
Small Peptide
According to the company, i-Factor is the only biologic bone graft that utilizes a unique small peptide (P-15) to stimulate the natural bone healing process. Benefits include “predictable bone formation, and ease-of-use in a wide range of spine, trauma and orthopedic procedures.” The technology combines anorganic bone mineral (ABM) and P-15 to act as an attachment factor for specific integrins on osteogenic cells.
Pivotal Trial Comparison
A pivotal clinical trial compared Cerapedics’ bone graft to autograft in anterior cervical discectomy and fusion (ACDF) procedures. According to the company, its graft met all four pre-specific primary endpoints (fusion rate, NDI (Neck Disability Index) score, neurological outcomes, and safety success), “demonstrating non-inferiority to autograft with p-values of < 0.0005 for each.”
A responder analysis showed statistical significance for superiority in all four primary outcomes, demonstrating 69% success for the bone graft versus 57% for autograft.
The company also announced that it has filed a response to remaining items from an FDA’s review of the graft from a recently completed facility inspection.
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Discussion
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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