Here are five takeaways:
1. This is the first bone graft approved for use in the cervical spine.
2. Based on synthetic small peptide technology, the i-FACTOR bone graft is designed to promote bone growth through cell attachment and activation.
3. It may be used in place of autologous bone in ACDF procedures.
4. In a clinical trial, the i-FACTOR bone graft showed 69 percent success in four outcomes, while the autograft showed 57 percent success in four outcomes.
5. With this FDA approval, Cerapedics plans to commercially launch the i-FACTOR bone graft in the United States.
“Now, for the first time spine surgeons in the U.S. will have access to biological bone graft based on our proprietary P-15 technology platform, providing a safe and effective alternative to a patient’s own bone and other less studied products that are being marketed for cervical spine procedures,” said Glen Kashuba, CEO of Cerapedics.
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