WESTMINSTER, Colo., June 13, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that it has been selected as a winner in the 2018 MedTech Breakthrough Awards program. The award recognizes the company’s i‑FACTOR™ Peptide Enhanced Bone Graft as the best new surgical technology solution.
“We are pleased to be recognized as one of the top companies, technologies, and products in the global health and medical technology market,” said Glen Kashuba, chief executive officer of Cerapedics. “i‑FACTOR Peptide Enhanced Bone Graft is an innovative solution for orthopedic surgeons who are looking for a safe, clinically proven and cost-effective bone graft that is supported by Level 1 human data, and we are focused on gathering additional clinical evidence supporting its use and addressing the evidence gap around commercial bone grafts often used in spinal fusion procedures.”
i‑FACTOR Peptide Enhanced Bone Graft is based on proprietary biomimetic small peptide (P-15) technology that 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 disc disease. This unique drug-device technology enhances the body’s natural bone healing process through cellular activity that is directional and predictable. i‑FACTOR Peptide Enhanced Bone Graft is only the second bone graft to receive Premarket Approval (PMA) in the spine, and it is supported by proven safety and efficacy data through an investigational device exemption (IDE) clinical trial.
“For the hundreds of thousands of people suffering from severe back pain, degenerative disc disease and need a spinal fusion, Cerapedics has developed an innovative therapy to enhance bone healing with i‑FACTOR Peptide Enhanced Bone Graft, a novel PMA-approved small peptide bone graft,” said James Johnson, managing director at MedTech Breakthrough. “We congratulate Cerapedics on developing an innovative, evidence-based technology that has the opportunity to become an industry standard of care, and we are thrilled to recognize them as a 2018 MedTech Breakthrough Award – Surgery winner.”
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary biomimetic 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.
i‑FACTOR Peptide Enhanced Bone Graft Indications for Use
USA: 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 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i‑FACTOR™ Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.
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