Cerapedics ifactor
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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.
#CERAPEDICS IFACTOR TRIAL#
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. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA.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. The drug-device combination is based on synthetic small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. We are very excited about FDA’s approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR.”Ĭerapedics commercialized i‑FACTOR Bone Graft beginning in 2016. Glen Kashuba, chief executive officer, said, “Since the commercial release of i-FACTOR Bone Graft in the US market, Cerapedics has been successful in rapidly penetrating the US Ortho-Biologics market by emphasizing the importance of Level I human clinical data.
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“We believe 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. “We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR 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 has been maintained at two-year follow up,” said Jeffrey Marx, Ph.D., president and chief operating officer of Cerapedics.
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Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics, a private ortho-biologics company, has announced the U.S.