![]() It is in a new category of bone graft technology and is one of only two drug/device combination products approved by the FDA, joining Medtronic’s Infuse. ![]() ![]() The drug/device combination is based on synthetic small peptide technology that accelerates new bone formation. FavoriteĬerapedics launched i‑FACTOR in 2016. Manuel with a solid background in banking and Cosmin as an entrepreneur, are familiar with the difficulties that SMEs face when looking to access the necessary working capital from banks. spine surgeons can feel confident in choosing i-FACTOR Peptide Enhanced Bone Graft. At the heart of our initiative is innovation, transforming iFactor into a solution out of the traditional patterns of financing methods. It is in a new category of bone graft technology and is one of only two drug/device combination products approved by the FDA, joining Medtronic’s Infuse. in the Medical Device industry and member of the Forbes Councils. and around the world.”Ĭerapedics launched i‑FACTOR in 2016. “We believe i-FACTOR Bone Graft represents one of the most important technological breakthroughs in this field and are committed to compiling extensive Level I human clinical data to support its use across the U.S. “We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR labeling to reflect longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year has been maintained at two-year follow-up,” said Jeffrey Marx, Ph.D., President and Chief Operating Officer. Analysis of combined endpoints for overall success demonstrated 70% success for patients receiving i-FACTOR vs. Cerapedics requested approval for an updated package insert that incorporates 24-month follow-up data from subjects enrolled in the original clinical study.Ī review of 2-year follow-up data from an FDA Investigational Device Exemption clinical trial of i-FACTOR indicated its statistical superiority in overall clinical success to autograft in ACDF. FDA approved Cerapedics’ Premarket Approval (PMA) supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion to treat degenerative cervical disc disease.
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