Since approval, ABM/P-15 has been used in an estimated 500,000 procedures.įrom these roots, Cerapedics has reformulated the (ABM/P-15) product and branded it i-FACTOR Peptide Enhanced Bone Graft to capture the unique “attachment factor” mechanism of action. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. DCPD + -TCP/CaSO4 PRO-DENSE (Wright Medical Group, TN, USA) OCP/fibrin FibroFor (BioNova, Russia) Undisclosed CaPO 4 + biologics i-FACTOR (Cerapedics. i-FACTOR Peptide Enhanced Bone Graft is the only. The first P-15 enhanced bone graft substitute was developed for use in the oral cavity by CeraMed Dental – the precursor to Cerapedics – under the leadership of Andrew J. Cerapedics is an ortho-biologics company focused on developing and commercializing its proprietary small peptide (P-15) technology platform. This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors.Our lead technology platform (i-FACTOR Peptide Enhanced Bone Graft) is the only biologic bone graft that uses a unique small peptide attachment factor (P-15) bound to anorganic bone mineral (ABM). i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. About CerapedicsĬerapedics is an ortho-biologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA. The drug-device combination is based on synthetic small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease.

We are very excited about FDA’s approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR.”Ĭerapedics commercialized i‑FACTOR Bone Graft beginning in 2016. 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. and around the world.” Market Penetration in Ortho-Biologics

“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. “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. Since introducing the i-FACTOR Peptide Enhanced Bone Graft to. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study. Cerapedics is a private ortho-biologics company headquartered in the Denver metropolitan area. 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. 18, 2019 /PRNewswire/ - Cerapedics, a private ortho-biologics company, today announced the U.S. The i-FACTOR® Peptide Enhanced Bone GraftĬontinues to demonstrate statistical superiority to autologous bone in cervical spine surgery

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