Cerapedics today announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) supplement for i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study.
“We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR labelling to reflect longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year has been maintained at two-year follow up,” said Jeffrey Marx, president and chief operating officer of Cerapedics. “We believe i-FACTOR Bone Graft represents one of the most important technological breakthroughs in this field and are committed to compiling extensive Level I human clinical data to support its use across the US and around the world.”
Glen Kashuba, chief executive officer said, “Since the commercial release of i-FACTOR Bone Graft in the US market, Cerapedics has been successful in rapidly penetrating the US Ortho-Biologics market by emphasising the importance of Level I human clinical data. We are very excited about FDA’s approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR.”
Cerapedics commercialised i-FACTOR bone graft beginning in 2016. The drug-device combination is based on synthetic small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA.