WESTMINSTER, Colo., Oct. 17, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, today announced long-term follow-up data from its pivotal IDE study of i-FACTOR Peptide-Enhanced Bone Graft. 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. In particular, the results further support the safety and efficacy profile of i-FACTOR at one and two years, as published in Spine and Neurosurgery.
i-FACTOR has proven statistical superiority vs. local autograft in overall success* at one and two-year endpoints for single-level ACDF. i-FACTOR further demonstrated spine fusion rates of 89.7%, 97.3%, and 98.6% at one, two, and six years, respectively, versus 85.8%, 95.8%, and 97.3% for local autograft, with results published in Spine and Neurosurgery. 220 of the original 319 patients were observed over six years or 72 months.
The six-year results, published earlier this year in Neurosurgery, were based on a single blinded, randomized controlled prospective study of i-FACTOR compared to local autograft in single-level ACDF, which included a total of 220 patient subjects with 106 in the i-FACTOR group and 114 in the local autograft control arm. Of the 22 sites from the original IDE study, 17 participated in this six-year post- approval study.
“Clinicians are looking for long-term safety and efficacy data to support decision-making about the safest and most effective spine technologies,” said Professor Paul Arnold, CARLE Illinois College of Medicine, principal investigator and author of the study’s 12-, 24-, and 72-month publications. “In this unique long-term follow-up data from a pivotal IDE study, i-FACTOR met all four FDA-mandated non-inferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion compared to autograft at 12, 24, and 72 months.”
“These results clearly demonstrate the efficacy rates and safety profile of i-FACTOR over an extended period and also reflect Cerapedics’ commitment to producing the highest quality evidence on the use of our products,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “Combined with the IDE study results, these data add to the clinical understanding of i-FACTOR’s efficacy and safety. Although there are numerous other bone graft options, many have not undergone the same level of testing. This data is impactful for insurance payers who seek Level 1 evidence as they make coverage decisions.”
i-FACTOR is available in the US through a premarket approval. It is the most stringent type of device marketing application required by the FDA and involves the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices based on Level 1 clinical trials. Cerapedics is currently conducting its second clinical randomized controlled trial for a transforaminal lumbar interbody fusion (TLIF) indication with 290 subjects, which is registered on clinicaltrials.gov.
About i-FACTOR Peptide-Enhanced Bone Graft
i-FACTOR is a Class III FDA approved bone graft backed by rigorous Level 1 human clinical data from an IDE study published in Spine and Neurosurgery. It is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, with a precise bone-building mechanism.** i-FACTOR has a demonstrated safety profile and is as safe as local autograft in single-level ACDF with proven statistical superiority in overall success* at one and two years.
i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation. For more information, full description of the indication for use, contraindications, safety warnings, etc. about i-FACTOR , please visit our website: https://www.cerapedics.com/sites/default/files/2023-08/40002-07-4%20Putty%20USA.pdf
Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair by healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. i-FACTOR is a Class III FDA-approved product indicated for single-level ACDF. Cerapedics’ new “P-15 Bone Graft” product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal clinical study, and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.
For more information, visit us at www.cerapedics.com.
Ten Bridge Communications
*Defined as meeting Fusion, Function (Neck Disability Index), Neurological and Safety endpoints
**Surface-bound mechanism of action
SOURCE Cerapedics Inc.