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Cerapedics gets FDA premarket approval for first bone graft to be used in cervical spine

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Cerapedics recently announced the FDA has approved the company’s premarket approval application for the i-FACTOR Peptide Enhanced Bone Graft.

According to a company release, the i-FACTOR is the first FDA-approved bone graft for use in the cervical spine and the second bone graft to receive FDA premarket (PMA) approval for use in the spine.

“This is an historic milestone for us at Cerapedics and also for the surgical treatment of cervical disc degeneration,” Jeffrey G. Marx, PhD, president and chief operating officer of Cerapedics, stated in the release. “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.”

The i-FACTOR bone graft is indicated for use in patients with degenerative cervical disc disease who will undergo anterior cervical discectomy and fusion (ACDF). The graft is based on synthetic proprietary small peptide (P-15) technology that uses cell attachment and activation to enhance bone growth. According to the release, it can be used as a substitute for autologous bone in ACDF procedures.

“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,” Glen Kashuba, chief executive officer of Cerapedics, stated in the release. “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.”

Reference:

www.cerapedics.com.