Wednesday November 4, 2015 0 comments
WESTMINSTER -- Cerapedics, a privately-held orthobiologics company, announced the FDA has approved the company’s Premarket Approval application for i-FACTOR Peptide Enhanced Bone Graft for use in procedures in patients with degenerative cervical disc disease.
Cerapedics’ i-FACTOR bone graft is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft for the spine, the company said.
“This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration,” said Jeffrey G. Marx, Cerapedics president and COO.
“It is the culmination of years of seamless cooperation with our clinical investigators to support PMA approval. 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.”
i-FACTOR bone graft is based on synthetic small peptide technology developed by Cerapedics to support bone growth through cell attachment and activation.
“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,” said Glen Kashuba, Cerapedics CEO.
"The approval will allow for the immediate U.S. commercial release of i-FACTOR bone graft and represents a significant achievement for Cerapedics.”