Cervical Disk Articles & Analysis
6 news found
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 clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...
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 of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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). In this landmark ...
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 through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of ...
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. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...
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 and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that ...