8 News & Press Releases found
Cerapedics, Inc. News
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Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone ...
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Cerapedics Announces FDA approval of an IDE supplement
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going ...
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Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print ...
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Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) ...
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Cerapedics Announces Publication of Results of Study Evaluating the Cost-Effectiveness of i-FACTOR vs. Local Autologous Bone in ACDF Surgery
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 ...
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Cerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada ...
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Cerapedics Announces Canadian Approval of its next-generation bone graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. ...
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Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data
Cerapedics, a private ortho-biologics company, today announced the U.S. 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 ...