FDA Tells Cerapedics Advisory Committee Panel Isn’t Required for i-Factor PMA Approval

Officials with the U.S. Food and Drug Administration (FDA) have informed Westminster, Colo.-based Cerapedics, a privately held orthobiologics company, that an advisory committee panel meeting will not be required for the final review of the firm’s premarket approval (PMA) application for i-Factor Peptide Enhanced Bone Graft.

The company also reported filing a “comprehensive response” to the last few remaining items from the PMA review of i-Factor, including those from a recently completed pre-approval facility inspection.

“We were pleased to receive notice from the FDA that we can move forward in the PMA review process without a panel meeting. We appreciate the interactive nature of the FDA review process, which has streamlined our application,” said Jeffrey G. Marx, Ph.D., president and chief operating officer of Cerapedics.

The i-Factor bone graft is based on P-15 technology developed by Cerapedics to support bone growth through cell attachment and activation. The PMA application is supported by data from a pivotal clinical trial comparing i-Factor bone graft to autograft in anterior cervical discectomy and fusion (ACDF) procedures. In the trial, i-Factor bone graft met all four pre-specified primary endpoints (fusion rate, NDI score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of < 0.0005 for each, according to the company. In addition, a responder analysis for overall success in all four primary outcomes demonstrated 69 percent success for i-Factor bone graft versus 57 percent for autograft. This was statistically significant for superiority (p = 0.038).

“Leading with this excellent clinical profile and what we believe will become the only biologic bone graft approved for cervical fusion, we think that i-Factor bone graft will be an important product for patients and clinicians. We are excited to be advancing i-Factor bone graft through the regulatory process and are now shifting our focus toward planning for U.S. commercialization,” said Glen Kashuba, CEO of Cerapedics. “We would like to thank all of our clinical investigators and other contributors. Without their efforts, we would not be in this position today.”

Cerapedics is developing biologic bone graft products for orthopedic procedures including spinal fusion, traumatic fracture treatment, and joint reconstruction.

According to the company,  i-Factor is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. The novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors.

Earlier this year, the company received CE mark in Europe and Therapeutic Goods Administration listing in Australia for the new i-Factor Flex FR biologic bone graft, which features the company’s proprietary synthetic small peptide bone graft technology with the addition of purified silk fibers to provide enhanced cohesion, mechanical properties, and handling characteristics.

In April, the company closed a loan and equity financing, including a $4 million term loan from GE Capital’s Healthcare Financial Services, which brings the total facility to $16.5 million. The company also raised an additional $4 million in equity financing from inside investors.