12/16/2023 0 Comments Ifactor cerapedicsi-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. Ĭerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. "Increasingly surgeons and hospitals are recognizing the advantages of the i‑FACTOR Peptide Enhanced Bone Graft's biomimetic small peptide technology in helping to improve safety and outcomes, and we hope this ISASS policy statement builds awareness among healthcare institutions and payors of the proven benefits of our technology and the importance of making it a covered treatment option for patients."įor more information about the ISASS bone grafting policy statement, visit. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery," added Jeffrey Marx, PhD, president and chief operating officer of Cerapedics. "i‑FACTOR Peptide Enhanced Bone Graft has a wealth of clinical evidence supporting its use as well as the potential to offer an economical alternative that aligns with the values of healthcare systems." of Neurosurgery, University of Illinois Carle School of Medicine. "We are continually hearing about the development of new technologies to support bone regrowth and repair, but little about the supporting clinical evidence," said Paul M. Cerapedics recently initiated a second investigational device exemption clinical trial to evaluate the safety and efficacy of the P-15 technology compared to autograft in transforaminal lumbar interbody fusion surgery. Prior research indicates that i‑FACTOR Peptide Enhanced Bone Graft is superior to the historical "gold standard" autograft in overall clinical success. I‑FACTOR Peptide Enhanced Bone Graft has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disk disease. "The ISASS statement notes that i‑FACTOR Peptide Enhanced Bone Graft is based on a well-established mechanism of action and carries extensive clinical data including level 1 human data that strongly supports its safety and efficacy." "We are very pleased that ISASS has issued this important policy update that differentiates our proprietary biomimetic small peptide (P-15) technology from other bone grafting products that have little or no clinical evidence," said Glen Kashuba, chief executive officer of Cerapedics. Food & Drug Administration (FDA) through the Premarket Approval (PMA) process and supported by level 1 clinical data. WESTMINSTER, Colo., Ma/PRNewswire/ - Cerapedics, a privately-held orthobiologics company, today announced that the International Society for the Advancement of Spine Surgery (ISASS) issued a new bone grafting policy with recommendations on usage and payor coverage criterion that features i‑FACTOR™ Peptide Enhanced Bone Graft as one of only two drug-device combination products approved by the U.S.
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