#Ifactor ortho trial#

The approval will allow for the immediate U.S. will have access to a biologic bone graft based on our proprietary P-15 technology platform, providing a safe and effective alternative to a patient’s own bone and other less studied products that are being marketed for cervical spine procedures. Now for the first time spine surgeons in the U.S. “We are extremely pleased and excited about the FDA’s approval of I-Factor bone graft for cervical spinal fusions, a large and growing market segment that, up until now, has been lacking the optimal product solution.

#Ifactor ortho trial#

The study reported the I-Factor graft met 4 pre-specified endpoints related to fusion rate, NDI score, neurological outcomes and safety success, the company said.ĭata from the trial reported a 69% success rate in all 4 primary outcomes for the I-Factor versus 57% for the autograft, the company said. This novel mechanism of action enhances the bodys natural bone healing process resulting in safe, predictable bone formation. Autologous bone marrow aspirate obtained from the iliac crest is also commonly used during orthopedic procedures as an adjunct to other graft materials to. The PMA approval was supported by data from a pivotal clinical trial pitting the I-Factor bone graft against an autograft in ACDF procedures. i-FACTOR Putty combines a unique anorganic bone mineral (ABM) and small peptide (P-15) that acts as an attachment factor for specific integrins on osteogenic cells. With our transition to a commercial stage company, all of us at Cerapedics look forward to bringing an important new biologic bone graft option, the only backed by significant level-1 clinical evidence, to surgeons and patients across the U.S.,” COO & prez Jeffrey Marx said in a press release. It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. “This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration. Westminster, Colo.-based Cerapedics said the I-Factor graft is the 1st bone graft approved for use in cervical spine procedures and the 2nd PMA cleared bone graft for the spine. i-FACTOR Bone Graft products are intended to replace or augment the use of autologous bone commonly utilized in spine, trauma, and orthopedic. Cerapedics said yesterday it won FDA premarket approval for its I-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures for patients with degenerative cervical disc disease. This enables i-FACTOR Flex FR to provide significant new application options while retaining the safety and efficacy of P-15 technology.