Cerapedics filed a premarket approval application with the U.S. Food & Drug Administration for it's i-FACTOR Peptide Enhanced Bone Graft.
The application is supported by data from a clinical trial demonstrating that i-FACTOR bone graft can be used as an alternative to autograft harvesting in anterior cervical discectomy and fusion procedures.
"We are excited to advance i-FACTOR toward becoming only the second PMA-approved bone graft and the first to be approved for use in the cervical spine. We look forward to leveraging the reimbursement and commercial potential of our Level I data and unique regulatory position, which are key factors supporting success in today's healthcare environment," said Jeff Marx, PhD, president and COO of Cerapedics.
Cerapedics is an orthobiologics company focused on developing and marketing its proprietary synthetic small peptide technology platform.
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