This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. 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 is free of many safety risks seen with other products such as ectopic bone formation and on average costs at least 30% less expensive than other drug-device combination products. One of only two Class III FDA-PMA approved spinal bone grafts, i-FACTOR is the leading evidence-based alternative and is powered by a first of its kind molecule called P-15: Osteogenic Cell Binding Peptide. In this study i-FACTOR demonstrated high fusion rates and statistical superiority vs. in Ceramic Engineering from Missouri University of Science and Technology, Rolla MO.Ĭerapedics is an advanced orthobiologics company with i-FACTOR® Peptide Enhanced Bone Graft.Īmong 400+ spinal bone grafts on the market, spine surgeons can feel confident in choosing i-FACTOR Peptide Enhanced Bone Graft which is backed by Level 1 human clinical data from an IDE study published in Spine and Neurosurgery. When Orthovita was acquired by Stryker Orthobiologics, Jeff led the team that integrated the two companies he continued as VP Corporate Development at Stryker. His experience includes over 13 years with Orthovita, where he was VP Corporate Development. With some two decades of experience in executive management with medical device companies, he brings considerable expertise in research & development, commercialization, sales management, business development and strategic planning. "We look forward to advancing the clinical research program for i-FACTOR biologic bone graft as we continue to investigate potential new applications for our proprietary small peptide technology.Jeffrey Marx serves as President & Chief Operating Officer, overseeing regulatory, quality, manufacturing, and R&D efforts for the company. "The results represent a major advance in our commitment to developing and commercializing novel orthobiologic products," said Glen Kashuba, CEO at Cerapedics. i-FACTOR biologic bone graft is composed of anorganic bone matrix (ABM) enhanced with synthetic small peptide (P-15), based on a proprietary technology developed by Cerapedics. The procedure requires patients to undergo a second surgery to harvest bone for use in the grafting procedure. The current standard of care to achieve arthrodesis in ALIF procedures is autologous bone graft typically obtained from the iliac crest along the largest bone in the pelvis. "The use of orthobiologic materials that can deliver high fusion rates without the need to harvest autologous bone graft will represent a significant advance in patient care, and so these results involving treatment with i-FACTOR biologic bone graft are especially encouraging." "Grafting supports bone regeneration in a variety of cases in orthopedic surgery, but harvesting autologous bone graft has been associated with a number of complications including chronic pain, infection, and fracture," said Dr. Results also showed a statistically significant improvement between preoperative and postoperative scores when assessing patients using the Oswestry Low Back Pain Disability Questionnaire (ODI), Short Form-12, Odom's criteria score, and a visual analogue scale for pain (VAS). While the mean follow-up time for collection of radiological data was 24 months, evidence of fusion was demonstrated as early as 3-6 months post-surgery in some patients (43% of one-level, 44% of 2-level). The one-level fusion rate was 98 percent (78/80), the two-level fusion rate was 82 percent (22/27), and the three-level fusion rate was 100 percent (3/3). In total, 94 percent of patients achieved arthrodesis. Fusion rate was assessed using fine cut coronal CT scans. Treatment was shown to provide favorable clinical outcomes in patients who undergo ALIF surgery for degenerative spine conditions by facilitating successful fusion of two or more vertebrae, also known as arthrodesis. In the non-blinded study, a total of 110 patients were treated with i-FACTOR biologic bone graft and evaluated for fusion rates and clinical outcomes with a mean follow-up of two years. Mobbs, MD, Prince of Wales Hospital in Australia. Findings from the study, entitled, "Clinical Outcomes and Fusion Rates Following Anterior Lumbar Interbody Fusion with Bone Graft Substitute 'i-FACTOR' – an ABM/P-15 Composite," were presented by the research team led by Ralph J. Cerapedics, a privately-held orthobiologics company, today announced that results from the first prospective clinical study evaluating the safety and efficacy of i-FACTOR bone graft in anterior lumbar interbody fusion (ALIF) have been published in the peer-reviewed Journal of Neurosurgery: Spine.
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