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i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. "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."Ĭerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. "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.
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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.
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20, 2014 /PRNewswire/ - 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. "These data indicate that i-FACTOR Peptide Enhanced Bone Graft offers significant potential benefits in fusion rates compared to allograft," said Dr. Two-level concomitant degenerative olisthesis patients saw estimated fusion rates of 63 percent with i-FACTOR compared to 18 percent with allograft. Those patients with one-level concomitant degenerative olisthesis accomplished estimated fusion rates of 40 percent with i-FACTOR compared to 21 percent with allograft.ģ. At one-year postoperative follow-up, researchers found a 50 percent fusion rate using i-FACTOR versus a 20 percent fusion rate using allograft.Ģ. The patients underwent non-instrumented lumbar posterolateral spine surgery with either i-FACTOR Peptide Enhanced Bone Graft or allograft.ġ. The study involved 98 patients aged 60 or older who suffered from lumbar spinal stenosis or concomitant degenerative olisthesis. Andersen, MD, of Middelfart Hospital in Denmark, reported results from the IVANOS study investigating Cerapedics' i-FACTOR Peptide Enhanced Bone Graft.