1/31/2024 0 Comments Ifactor medical![]() Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Cerapedics initial P-15 technology product, i-FACTOR Peptide Enhanced Bone Graft, was approved in the European Union in 2008 and Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). I-FACTOR+ MATRIX utilizes a small proprietary peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of Cerapedics, “Canada will be the first market offering the i-FACTOR+ MATRIX product, which leverages the clinically proven P-15 osteogenic cell-binding peptide combined with a collagen carrier for optimized handling.” Photo: courtesy of Cerapedics, Inc.Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. Image: The trial will assess the and efficacy of P-15L peptide enhanced bone graft compared to autograft in TLIF surgery for degenerative disk disease. ![]() need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bone as well as address the evidence gap around commercial bone grafts often used in these procedures.” “Several hundred thousand people in the U.S. In November 2015, Cerapedics secured premarket approval from the FDA for the use of i-FACTOR bone graft in anterior cervical discectomy and fusion (ACDF) procedures.Ĭerapedics CEO Glen Kashuba said: “With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft. The trial will assess the patients prior to surgery and six weeks, three months, 12 months and 24 months post-surgery.Īccording to the company, the primary endpoint of the trial will be composite clinical success at 24 months based on various factors, including the achievement of radiographic fusion, at least 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit and no subsequent surgical intervention at the index level. The prospective, single-blinded, multi-center, randomized and non-inferiority pivotal IDE trial will recruit 364 patients with degenerative disk disease at around to 30 clinical trial sites across the US. A bone graft taken from the patient’s pelvis will be placed in the interbody space to enhance fusion.Īn alternative to autologous bone, the new bone graft is based on firm’s synthetic small peptide (P-15) technology and will support bone growth through cell attraction, attachment and activation. Spinal fusion procedures such as TLIF will include joining and stabilizing one or more vertebrae to decrease pain and nerve irritation. Under the IDE study, the company will assess the safety and efficacy of P-15L peptide enhanced bone graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease. Orthobiologics company Cerapedics has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial of P-15L bone graft.
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