“We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR labeling 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, Ph.D., 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 U.S. 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 emphasizing 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 commercialized 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.