Cerapedics received FDA approval for an Investigational Device Exemption clinical trial of P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion to treat degenerative disc disease.
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll 364 patients at up to 30 U.S. sites, with follow-up at 6 weeks, 3 months, 12 months and 24 months. Investigators can use any FDA-cleared static PEEK interbody and any FDA-cleared pedicle fixation system delivered in an open or minimally invasive technique.
P-15L graft is a substitute for autologous bone that is based on synthetic small peptide technology, developed to spur bone growth via cell attraction, attachment and activation.
In 2015, Cerapedics received FDA Premarket Approval for its i-FACTOR™ Peptide Enhanced Bone Graft for use as a substitute for autologous bone in anterior cervical discectomy and fusion in patients with degenerative disc disease. It remains one of only two PMA-approved bone grafts for spinal use.
Cerapedics received FDA approval for an Investigational Device Exemption clinical trial of P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion to treat degenerative disc disease.
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll 364 patients at up to 30...
Cerapedics received FDA approval for an Investigational Device Exemption clinical trial of P-15L Peptide Enhanced Bone Graft vs. autograft in transforaminal lumbar interbody fusion to treat degenerative disc disease.
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal study will enroll 364 patients at up to 30 U.S. sites, with follow-up at 6 weeks, 3 months, 12 months and 24 months. Investigators can use any FDA-cleared static PEEK interbody and any FDA-cleared pedicle fixation system delivered in an open or minimally invasive technique.
P-15L graft is a substitute for autologous bone that is based on synthetic small peptide technology, developed to spur bone growth via cell attraction, attachment and activation.
In 2015, Cerapedics received FDA Premarket Approval for its i-FACTOR™ Peptide Enhanced Bone Graft for use as a substitute for autologous bone in anterior cervical discectomy and fusion in patients with degenerative disc disease. It remains one of only two PMA-approved bone grafts for spinal use.
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