Cerapedics, a privately-held orthobiologics company, announced today the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) application for i-FACTOR™ Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease.
i-FACTOR bone graft is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine.
Says Jeffrey G. Marx, Ph.D., president and COO of Cerapedics;
“This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration. It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. With our transition to a commercial stage company, all of us at Cerapedics look forward to bringing an important new biologic bone graft option, the only backed by significant level-1 clinical evidence, to surgeons and patients across the U.S.”
i-FACTOR bone graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. It may be used as a substitute for autologous bone in ACDF procedures.