THIS COMBINATION PRODUCT 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. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.ĪPPROVAL FOR THE I-FACTOR PEPTIDE ENHANCED BONE GRAFT. Be sure to look at the supplements to get an up-to-date information on device changes. The device description/function or indication may have changed. i-FACTOR bone graft is the only biologic bone graft that utilizes a. Marx, Ph.D., President and COO, Cerapedics.Note: this medical device has supplements. i FACTORTM and P-15TM are registered trademarks of Cerapedics, Inc., CO, USA. “The next generation product we’re developing with DSM is showing tremendous potential, and will allow us to bring the bone forming potential of the P-15 technology into the lumbar spine,” said Jeffrey G. following the FDA Premarket Approval (PMA) of i-FACTOR Bone Graft, and we are excited to be partnered with DSM in delivering our next generation product to market,” said Glen Kashuba, CEO, Cerapedics. “Over the past year we have been focused on accelerating our commercialization efforts in the U.S. Cerapedics is partnering with DSM to collaboratively develop and commercialize the next generation of this technology. It's a synthetic replicate of a native peptide that is a part of type 1 collagen. The P-15 molecule is a 15 amino acid peptide. First and foremost, it is a drug device combination product, so is very active in terms of driving the biological response within the patient post-implantation. for anterior cervical discectomy and fusion (ACDF) procedures since late 2015. JM : i-FACTOR is different in a couple of important ways. discuss the future of the bone graft substitutes and the uniqueness of iFACTOR Peptide Enhanced Bone Graft, a small peptide technology in an interview with Kim French, Sr. Cerapedics’ CEO Glen Kashuba and President and COO Jeff Marx, Ph.D.
The company’s first-generation product, i-FACTOR™ Peptide Enhanced Bone Graft, has been commercially available outside of the U.S. SmartTRAK Interviews Cerapedics: i-FACTOR, a Novel Bone Graft. Randomised double-blind clinical trial of i-FACTOR Peptide Enhanced Bone Graft versus Bone Bank Allograft in non-instrumented lumbar fusion surgery. “Together, from concept to commercialization, we are at the leading edge of advanced healing solutions.”Ĭerapedics developed P-15 technology to support bone growth through cell attraction, attachment, and activation. “The partnership combines the industry leading expertise and capabilities in bioceramic materials of DSM with Cerapedics’ innovative growth factor, delivering a new product solution to improve people’s lives,” said David Yonce, Vice President and Global Head of Innovation at DSM Biomedical.
Under the partnership agreement with Cerapedics, DSM will also provide a collagen carrier, final packaging, and full support from concept through commercialization. The strategic partnership aligns DSM’s regenerative materials capabilities with proprietary synthetic small peptide (P-15) technology developed by Cerapedics.ĭSM’s newest bioceramic platform is a carbonated apatite matrix designed for fast, predictable remodeling in bone graft substitute applications.
DSM Biomedical, a global solutions provider in biomedical science and regenerative medicine, today announced that it is partnering with Cerapedics, a privately-held orthobiologics company, to develop and manufacture the next generation peptide enhanced bone graft.