New, two-year follow-up data for i-FACTOR™ Peptide Enhanced Bone Graft shows that the one-year superiority over autologous bone grafts in anterior cervical discectomy and fusion (ACDF) procedures for degenerative cervical disc disease, is sustained for two years.
So, Cerapedics, Inc. asked the FDA if they could update their package insert accordingly.
The FDA agreed.
On November 18, 2019, Cerapedics announced the change to i-FACTOR’s Premarket Approval (PMA) supplement for ACDF.
Company President and CEO Jeff Marx, Ph.D. said the approval allows labeling to reflect “longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year have been maintained at two-year follow up.”
He continued that he believes i-FACTOR Bone Graft “represents one of the most important technological breakthroughs in this field and are committed to compiling extensive Level I human clinical data to support its use across the U.S. and around the world.”
Cerapedics commercialized the bone graft in 2016. The drug-device combination, according to the company, is based on synthetic small peptide (P-15) technology “that accelerates new bone formation in patients with degenerative disc disease. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA.”
P-15 is a novel synthetic, 15-amino-acid polypeptide that, according to the referenced study, “mimics the cell-binding domain of type I collagen and is able to signal a mechanical and biochemical communication pathway that ultimately results in new bone formation.”
Study
The clinical data was published in Neurosurgery in September 2018. Study authors included Drs. Paul Arnold, Rick Sasso, Michael Janssen, Michael Fehlings, Robert Heary, Alex Vaccaro and Branko Kopjar.
The results of the data:
At 2 yr, the fusion rate was 97.30% and 94.44% in i-FACTOR and autograft subjects, respectively(P=.2513), and neurological success rate was 94.87%(i-Factor) and 93.79% (autograft; P=.7869). Neck Disability Index improved 28.30 (i-FACTOR) and 26.95 (autograft; P=.1448); Visual Analog Scale arm pain improved 5.43 (i-FACTOR) and 4.97 (autograft) (p =.2763); Visual Analog Scale neck pain improved 4.78 (i-FACTOR) and 4.41 (autograft; P=.1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-FACTOR) and 10.18(autograft=.4507), and SF36v2 Mental Component Score improved 7.88 (i-FACTOR) and 7.53(autograft=.9872).
The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of reoperations) was greater in i-FACTOR subjects compared to autograft subjects (69.83% and 56.35%, respectively=.0302). Twelve (7.45%) i-FACTOR subjects and 16 (10.53%) autograft subjects underwent re-operation (P=.3411). There were no allergic reactions associated with i-FACTOR.
The conclusion:
Use of i-FACTOR in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
Company CEO Glen Kashuba, said, since the commercial release of the bone graft in the U.S. market, “Cerapedics has been successful in rapidly penetrating the US Ortho-Biologics market by emphasizing the importance of Level I human clinical data. We are very excited about FDA’s approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR.”
