Cerapedics, Inc. news

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 Graft for the treatment of degenerative disc disease (DDD). The FDA’s Breakthrou

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 p

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 statistically significantly higher

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) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease (DDD). Results from the study are intended to be used in a Premarket Approva

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 study, the data demonstrates that i-FACTOR was cost-effec

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, “Canad

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+  Matrix,” said Glen Kashuba

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 incorporates the 24-month follow-up data from subjects enrolled in the original cli