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Allograft Bone Articles & Analysis

6 news found

Cerapedics Announces FDA approval of an IDE supplement

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 clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...

ByCerapedics, Inc.


Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery

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 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 ...

ByCerapedics, Inc.


Cerapedics Announces Publication of Results of Study Evaluating the Cost-Effectiveness of i-FACTOR vs. Local Autologous Bone in ACDF Surgery

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 patients undergoing ACDF surgery were recently published in ClinicoEconomics and Outcomes Research (July 2021, Volume 2021, Issue 13). In this landmark ...

ByCerapedics, Inc.


Cerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada

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 through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of ...

ByCerapedics, Inc.


SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications

SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications

The 3D GraftRasp System is the only device to receive FDA clearance that allows for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft. It is approved for general orthopedic use and spine procedures. “In spine procedures, the transverse processes and facet joints may now be targeted in a more efficient and effective surgical technique pioneered by ...

BySurgentec LLC


Cerapedics Announces Canadian Approval of its next-generation bone graft

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. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...

ByCerapedics, Inc.

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