Drugs / i-FACTOR
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01618435 | Mar 2012 → Jun 2013 | spinal stenosis | Sygehus Lillebaelt | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-09-24 | CeraPedics, Inc | Regulatory Cerapedics’ i-FACTOR P-15 Peptide Enhanced Bone Graft, a Trusted Choice in Bone Graft Solutions, Now Approved for Expanded Indications for Use cerapedics.com ↗ |
| 2023-10-17 | CeraPedics, Inc | Results Cerapedics Reinforces Commitment to Level 1 Evidence with Long-Term Results from Six-Year Pivotal IDE Cervical Study Demonstrating 98.6% Spine Fusion Rates in Patients Treated With i-FACTOR® cerapedics.com ↗
Published data demonstrated fusion rates in single-level Anterior Cervical Discectomy and Fusion (ACDF) of 98.6% after six years in patients treated with i-FACTOR and reinforces Cerapedics’ commitment to capturing long-term clinical evidence. |
| 2021-08-17 | CeraPedics, Inc | Results Cerapedics Announces Publication of Results of Study Evaluating the Cost-Effectiveness of i-FACTOR vs. Local Autologous Bone in ACDF Surgery cerapedics.com ↗
In this landmark study, the data demonstrates that i-FACTOR was cost-effective compared to local autograft in ACDF surgery. |
| 2020-09-15 | CeraPedics, Inc | Regulatory Cerapedics Announces Canadian Approval of its next-generation bone graft cerapedics.com ↗
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. |
| 2020-07-22 | CeraPedics, Inc | Regulatory Cerapedics Announces FDA approval of an IDE supplement cerapedics.com ↗
WESTMINSTER, Colo., July 22, 2020 -- 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. |
| 2020-05-19 | CeraPedics, Inc | Results Cerapedics Announces Results from Clinical Trial of i-FACTOR® Peptide Enhanced Bone Graft in Lumbar Fusion Surgery cerapedics.com ↗
The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate compared to allograft plus local bone. |
| 2019-11-18 | CeraPedics, Inc | Regulatory Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data cerapedics.com ↗
WESTMINSTER, Colo., November 18, 2019 -- 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. |
| 2018-05-21 | CeraPedics, Inc | Results Cerapedics announces results from IVANOS study of i-FACTOR Peptide Enhanced Bone Graft cerapedics.com ↗
Results demonstrated a 50 percent fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20 percent fusion rate (23/114) using allograft at one-year postoperative follow-up. |
| 2015-11-03 | CeraPedics, Inc | Regulatory Cerapedics receives FDA approval for i-FACTOR Peptide Enhanced Bone Graft in Cervical Spine Surgery cerapedics.com ↗
Cerapedics, a privately-held orthobiologics company, announced today the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) application for i-FACTOR Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. |
| 2015-06-16 | CeraPedics, Inc | Regulatory Cerapedics announces FDA Advisory Committee Panel Is not required for i-FACTOR PMA Approval cerapedics.com ↗
Furthermore, the company has filed a comprehensive response to the last few remaining items from the PMA review of i-FACTOR Peptide Enhanced Bone Graft, including those from a recently completed pre-approval facility inspection. |
| 2015-02-17 | CeraPedics, Inc | Results Study supports use of Cerapedics i-FACTOR Biologic Bone Graft as alternative to Autograft in common spine surgery for chronic back pain cerapedics.com ↗
During the study, bridging bone inside hollow disc cages in the spine developed earlier with the use of i-FACTOR™ biologic bone graft when compared to autograft, while average pain decreased and function improved. |
| 2015-01-14 | CeraPedics, Inc | Regulatory Cerapedics receives CE mark and TGA listing for new i-FACTOR™ Flex FR Biologic Bone Graft cerapedics.com ↗
We are pleased to receive CE Mark approval and TGA listing for the new i-FACTOR Flex FR biologic bone graft," said Glen Kashuba, CEO at Cerapedics. |
| 2014-10-20 | CeraPedics, Inc | Results Novel i-FACTOR Biologic Bone Graft Shown to improve clinical outcomes in ALIF procedures cerapedics.com ↗
Cerapedics, a privately-held orthobiologics company, today announced that results from the first prospective clinical study evaluating the safety and efficacy of i-FACTOR bone graft in anterior lumbar interbody fusion (ALIF) have been published in the peer-reviewed Journal of Neurosurgery: Spine . |
| 2014-03-11 | CeraPedics, Inc | Results Cerapedics announces positive results from IDE clinical trial cerapedics.com ↗
Preliminary analysis of the results indicates that treatment with i-FACTOR met the pre-specified primary end points. |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | i-FACTOR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01618435 ↗ |
| Known as | i-FACTORputty, Cerapedics, USA. CE-brand 0086 | “i-FACTOR®putty, Cerapedics, USA. CE-brand 0086” NCT01618435 ↗ |