, /PRNewswire/ -- 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.
"This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration," said , Ph.D., president and COO of Cerapedics. "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."
Berry & Company Public Relations