Cerapedics Reinforces Commitment to Level 1 Evidence with Long-Term Results from Six-Year Central IDE Cervix Study Showing 98.6% of Spinal Fusions Occurring in Patients Treated with i-FACTOR®

WESTMINSTER, Colo., Oct. 17, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedic company committed 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 single-level anterior cervical discectomy and fusion (ACDF) fusion rates of 98.6% after six years in patients treated with i-FACTOR and reinforce Cerapedics’ commitment to accumulating long-term clinical evidence. In particular, the results support the safety and efficacy profile of i-FACTOR at one and two years, as published in Spine And Neurosurgery.

i-FACTOR has demonstrated statistical superiority over 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 for 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 enrolled a total of 220 patients, including 106 in the i-FACTOR group and 114 in the local autograft control arm. Of the 22 locations from the original IO study, 17 participated in this six-year post-approval study.

“Physicians 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 12-, 24- and publications from 72 months. “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 years of age age. , 24 and 72 months.”

“These results clearly demonstrate the efficacy rates and safety profile of i-FACTOR over time 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 results of the IDE study, these data contribute to the clinical understanding of the efficacy and safety of i-FACTOR. While there are numerous other bone grafting options, many have not undergone the same level of testing. This data has a significant impact on insurance payers looking for Level 1 evidence when making coverage decisions.”

i-FACTOR is available in the US through pre-market approval. It is the most stringent type of 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 an indication for transforaminal lumbar interbody fusion (TLIF) involving 290 subjects, which is registered onclinicaltrials.gov.

About i-FACTOR Peptide-enhanced bone graft
i-FACTOR is a Class III FDA-approved bone graft supported 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 overall success* after one and two years.

i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for the reconstruction of a degenerated cervical intervertebral disc at one level from C3-C4 to C6-C7. i-FACTOR Peptide Enhanced Bone Graft should be used in an allograft bone ring and with additional 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

About Cerapedia
Cerapedics is a global commercial-stage orthopedic company that aims to redefine the standard of care for bone repair by healing bones faster and faster, without compromising safety, so patients can live their healthiest lives. Bone grafts, including Cerapedics products, are used in more than four million spine, orthopedics, trauma and interventional procedures worldwide each year. 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 trial, and has received Breakthrough Device Designation from the FDA. Cerapedics is headquartered in Westminster, CO.

For more information, please visit us at www.cerapedics.com.

Media contact:
Ten Bridge communications
TBCCerapedics@tenbridgecommunications.com

*Defined as meeting the Fusion, Function (Neck Disability Index), Neurological, and Safety endpoints
**Surface-based mode of action

SOURCE Cerapedics Inc.