It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA. The drug-device combination is based on synthetic small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. We are very excited about FDA’s approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR.”Ĭerapedics commercialized i‑FACTOR Bone Graft beginning in 2016. Glen Kashuba, chief executive officer, said, “Since the commercial release of i-FACTOR Bone Graft in the US market, Cerapedics has been successful in rapidly penetrating the US Ortho-Biologics market by emphasizing the importance of Level I human clinical data. “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 of Cerapedics. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study. Whats Mergr We built Mergr to save people the arduous and time-consuming process of tracking when companies are bought, sold, and who currently owns them. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics, a private ortho-biologics company, has announced the U.S.
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