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.
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.
“This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration. 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.,” COO & prez Jeffrey Marx said in a press release.
The PMA approval was supported by data from a pivotal clinical trial pitting the I-Factor bone graft against an autograft in ACDF procedures. 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.
Data 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.
“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. Now for the first time spine surgeons in the 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. The approval will allow for the immediate U.S. commercial release of I-Factor bone graft and represents a significant achievement for Cerapedics,” CEO Glen Kashuba said in a prepared statement.
Cerapedics said it is engaged with distributors and preparing to hire direct sales reps to support a commercial launch of the product.