Society states company's drug-device combination technology shown to be safe and effective as autograft replacement with compelling clinical evidence
WESTMINSTER, Colo., March 6, 2019 /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. Food & Drug Administration (FDA) through the Premarket Approval (PMA) process and supported by level 1 clinical data.
"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. "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."
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. Prior research indicates that i‑FACTOR Peptide Enhanced Bone Graft is superior to the historical "gold standard" autograft in overall clinical success. 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.
"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. Arnold, MD, Chairman, Dept. of Neurosurgery, University of Illinois Carle School of Medicine. "i‑FACTOR Peptide Enhanced Bone Graft has a wealth of clinical evidence supporting its use as well as the potential to offer an economical alternative that aligns with the values of healthcare systems."
"More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery," added Jeffrey Marx, PhD, president and chief operating officer of Cerapedics. "Increasingly surgeons and hospitals are recognizing the advantages of the i‑FACTOR Peptide Enhanced Bone Graft's biomimetic small peptide technology in helping to improve safety and outcomes, and we hope this ISASS policy statement builds awareness among healthcare institutions and payors of the proven benefits of our technology and the importance of making it a covered treatment option for patients."
For more information about the ISASS bone grafting policy statement, visit https://www.isass.org/public-policy/isass-publishes-policy-statements-on-bone-graft-procedures-and-vertebral-augmentation/.
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.
CAUTION: P-15L Bone Graft is an Investigational Product limited by Federal (USA) Law to Investigational Use.
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SOURCE Cerapedics, PRNewswire March, 6, 2019