It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the U.S. The drug-device combination product is based on small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. for use in anterior cervical discectomy and fusion (ACDF) procedures in 2015. I-FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the U.S. Marx, Ph.D., President, and Chief Operating Officer. The technologies we displace with i-FACTOR don't have cost-effectiveness data, and most have no meaningful clinical data as well," said Jeffrey G. As our healthcare system becomes ever more focused on value in addition to quality clinical outcomes, this data puts us in a unique position relative to our competition.
Ament and his team for conducting this important and infrequently conducted analysis. This comprehensive, cost-effectiveness analysis was the next critical and necessary step to provide clear support for a better alternative to autograft. I-FACTOR has already demonstrated safety and improved outcomes compared to local autograft based on one and two year published data in Spine & Neurosurgery Journals 1,2. The results are felt to be conservative since, in a real world setting, many surgeons are using other more costly grafts in addition to autograft," commented Dr. At 1 year and beyond, these values became negative, suggesting a 'dominant' economic strategy. The incremental cost-effectiveness ratio proved highly cost-effective even at 90 days ( $13,333 per QALY).
#IFACTOR CERAPEDICS TRIAL#
"In a robust cost-utility analysis, i-FACTOR reduced costs within the first year compared to the control group (autograft) in the ACDF IDE trial population. In the base-case analysis, both health and societal system costs were evaluated. Two primary outcome measures were assessed: cost and utility. The study analyzed various real-world scenarios, including inpatient and outpatient surgical settings and private versus public insurances. The patient cohort was extracted from a prospective, multicenter randomized control trial (R.C.T.) from twenty-two North American centers.
#IFACTOR CERAPEDICS PROFESSIONAL#
Jared Ament, M.D., M.P.H., Director of Outcomes Research and Co-Director of Spine Neurosurgery at the Neurosurgery & Spine Group (N.S.G.) and President and Founder of Neuronomics, a professional corporation specializing in cost-effective analyses in the neurosciences, led this study.
#IFACTOR CERAPEDICS FULL#
Click here to download the full article.ĭr. In this landmark study, the data demonstrates that i-FACTOR was cost-effective compared to local autograft in ACDF surgery. 17, 2021 /PRNewswire/ - Cerapedics Inc., a private ortho-biologics company dedicated to enhancing the science of bone repair, announced today that results of a study to evaluate the cost-effectiveness of i-FACTOR Peptide Enhanced Bone Graft compared to autograft for patients undergoing ACDF surgery were recently published in ClinicoEconomics and Outcomes Research ( July 2021, Volume 2021, Issue 13).
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