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Ifactor bone graft1/7/2024 Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft technology platform into the rapidly expanding market for osteobiologic products. 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. 190, 192 This bone graft combination of ABM and P-15, also known as i-Factor, is claimed to facilitate bone formation. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. ABM consists of smooth, porous particles of pure deproteinated hydroxyapatite. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. 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. Peptide Enhanced Bone Graft in place in the disc space. This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. Ring allograft (structural) A ring-shaped bone graft that holds i-FACTOR. Level 1 evidence, presented at EUROSPINE 2018 in Barcelona, Spain, demonstrates that of i-FACTOR peptide enhanced bone graft results in significantly higher. Marx, Ph.D., President and COO, Cerapedics.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). “The next generation product we’re developing with DSM is showing tremendous potential, and will allow us to bring the bone forming potential of the P-15 technology into the lumbar spine,” said Jeffrey G. following the FDA Premarket Approval (PMA) of i-FACTOR Bone Graft, and we are excited to be partnered with DSM in delivering our next generation product to market,” said Glen Kashuba, CEO, Cerapedics. ![]() This novel mechanism of action increases the body’s natural bone healing process and thus leads to reliable. This unique ABM/P-15 combination acts as a binding link for osteogenic cells. “Over the past year we have been focused on accelerating our commercialization efforts in the U.S. i-FACTOR is the only bone graft substitute on the market that binds a small, synthetically produced peptide (P-15) to an inorganic bone mineral (ABM). We are extremely pleased and excited about the FDA’s approval of i-FACTOR bone graft for cervical spinal fusions, a large and growing market segment that, up until now, has been lacking the optimal. Cerapedics is partnering with DSM to collaboratively develop and commercialize the next generation of this technology. The proportion of i-FACTOR bone graft subjects with overall success was significantly higher than that of the autograft subjects (p 0.0382). for anterior cervical discectomy and fusion (ACDF) procedures since late 2015. History The first P-15 enhanced bone graft substitute was developed for use in the oral. This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. The company’s first-generation product, i-FACTOR™ Peptide Enhanced Bone Graft, has been commercially available outside of the U.S. ABOUT i-FACTOR Bone Graft 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). ![]() ![]() “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”Ĭerapedics developed P-15 technology to support bone growth through cell attraction, attachment, and activation. “The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” said David Yonce, Vice President and Global Head of Innovation at DSM Biomedical. Under the partnership agreement with Cerapedics, DSM will also provide a collagen carrier, final packaging, and full support from concept through commercialization. The strategic partnership aligns DSM’s regenerative materials capabilities with proprietary synthetic small peptide (P-15) technology developed by Cerapedics.ĭSM’s newest bioceramic platform is a carbonated apatite matrix designed for fast, predictable remodeling in bone graft substitute applications. DSM Biomedical, a global solutions provider in biomedical science and regenerative medicine, today announced that it is partnering with Cerapedics, a privately-held orthobiologics company, to develop and manufacture the next generation peptide enhanced bone graft.
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