of Neurosurgery, University of Illinois Carle School of Medicine. "We are continually hearing about the development of new technologies to support bone regrowth and repair, but little about the supporting clinical evidence," said Paul M.
Cerapedics recently initiated a second investigational device exemption clinical trial to evaluate the safety and efficacy of the P-15 technology compared to autograft in transforaminal lumbar interbody fusion surgery. Prior research indicates that i‑FACTOR Peptide Enhanced Bone Graft is superior to the historical "gold standard" autograft in overall clinical success.
I‑FACTOR Peptide Enhanced Bone Graft has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disk disease. "The ISASS statement notes that i‑FACTOR Peptide Enhanced Bone Graft is based on a well-established mechanism of action and carries extensive clinical data including level 1 human data that strongly supports its safety and efficacy."
"We are very pleased that ISASS has issued this important policy update that differentiates our proprietary biomimetic small peptide (P-15) technology from other bone grafting products that have little or no clinical evidence," said Glen Kashuba, chief executive officer of Cerapedics.
Food & Drug Administration (FDA) through the Premarket Approval (PMA) process and supported by level 1 clinical data. 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.WESTMINSTER, Colo., Ma/PRNewswire/ - Cerapedics, a privately-held orthobiologics company, today announced that the International Society for the Advancement of Spine Surgery (ISASS) issued a new bone grafting policy with recommendations on usage and payor coverage criterion that features i‑FACTOR™ Peptide Enhanced Bone Graft as one of only two drug-device combination products approved by the U.S. There were no allergic reactions associated with i-Factor™. Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation ( P =. The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P =. 4507), and SF36v2 Mental Component Score improved 7.88 (i-Factor TM) and 7.53 (autograft P =. 1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft P =. 2763) Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft P =. 1448) Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p =. Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft P =. 2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft P =. RESULTSĪt 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively ( P =. Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes.
A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. I-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier.