Cerapedics Inc.12.02.15
Westminster, Colo.-based Cerapedics Inc., an orthobiologics company, has earned U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the application of i-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. According to the company, 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 in the spine.
“This is a historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration,” said Jeffrey G. Marx, Ph.D., president and chief operating officer of Cerapedics. “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 United States.”
The i-Factor bone graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. It may be used as a substitute for autologous bone in ACDF procedures.
The PMA approval is driven by data from a pivotal clinical trial comparing i-Factor bone graft to autograft in ACDF procedures. In the trial, i-Factor bone graft met all four pre-specified primary endpoints (fusion rate, Neck Disability Index score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of < 0.0005 for each. 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. The proportion of i-Factor bone graft subjects with overall success was significantly higher than that of the autograft subjects (p = 0.0382).
According to the FDA, the bone graft 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 agency specifies that i-Factor must be used inside an allograft bone ring and with supplemental anterior plate fixation.
The PMA also stated that the bone graft should not be used in situations where there is an absence of load bearing structural support at the graft site; sensitivity to any components of the bone graft; acute or chronic infections, systemic or at the operative site; metabolic or systemic disorders that affect bone or wound healing; or compromised renal or hepatic function.
“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, CEO of Cerapedics. “Now for the first time spine surgeons in the United States 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.”
As a result of the FDA approval, Cerapedics has begun to engage a number of top-tier distributors, and is preparing to recruit a number of direct sales representatives, to support the U.S. commercial launch of i-Factor bone graft. The U.S. surgical market for biologic bone substitutes is estimated to be about $500 million.
“This is a historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration,” said Jeffrey G. Marx, Ph.D., president and chief operating officer of Cerapedics. “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 United States.”
The i-Factor bone graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. It may be used as a substitute for autologous bone in ACDF procedures.
The PMA approval is driven by data from a pivotal clinical trial comparing i-Factor bone graft to autograft in ACDF procedures. In the trial, i-Factor bone graft met all four pre-specified primary endpoints (fusion rate, Neck Disability Index score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of < 0.0005 for each. 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. The proportion of i-Factor bone graft subjects with overall success was significantly higher than that of the autograft subjects (p = 0.0382).
According to the FDA, the bone graft 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 agency specifies that i-Factor must be used inside an allograft bone ring and with supplemental anterior plate fixation.
The PMA also stated that the bone graft should not be used in situations where there is an absence of load bearing structural support at the graft site; sensitivity to any components of the bone graft; acute or chronic infections, systemic or at the operative site; metabolic or systemic disorders that affect bone or wound healing; or compromised renal or hepatic function.
“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, CEO of Cerapedics. “Now for the first time spine surgeons in the United States 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.”
As a result of the FDA approval, Cerapedics has begun to engage a number of top-tier distributors, and is preparing to recruit a number of direct sales representatives, to support the U.S. commercial launch of i-Factor bone graft. The U.S. surgical market for biologic bone substitutes is estimated to be about $500 million.