Cerapedics announced it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration for i-FACTOR Peptide Enhanced Bone Graft.
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 (ACDF) procedures supported the application. The clinical data were the last step in the premarket approval application, which was submitted by the company in modules, according to a press release from Cerapedics.
“The PMA filing is an important milestone in our effort to advance our proprietary synthetic small peptide (P-15) technology platform, which has the potential to provide significant benefits to patients and surgeons in the U.S. who currently rely on autograft and other less-studied bone graft products on the market today,” Glen Kashuba, CEO at Cerapedics, said in the press release.
Cerapedics presented preliminary outcomes data from an FDA Investigational Device Exemption clinical trial for the i-FACTOR bone graft in March.
With the PMA filing, final data from this trial have been submitted, according to the release.