Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, announced it is expanding its headquarters in the Denver metro area to support the growth of its products, which include the U.S. Food and Drug Administration (FDA)-approved i-FACTOR® bone graft for cervical spinal fusion and its next-generation product currently being evaluated for lumbar spinal fusion.
"Since the launch of i-FACTOR, we have seen a continuous increase in its use in spinal fusion. We are committed to supporting the needs of surgeons and their patients by expanding our facility," said Valeska Schroeder, Chief Executive Officer of Cerapedics. "We are fortunate to be based in Colorado and to recruit from the area's experienced, innovation-focused talent pool as we prepare to launch our next-generation product."
Cerapedics has fully enrolled its 290-patient randomized controlled clinical study evaluating the safety and efficacy of the next-generation P-15 Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgery. This next generation product has been granted breakthrough status by FDA and is being studied under an investigational device exemption (IDE).
By expanding its facility, Cerapedics is adding over 50 percent more space to its Colorado headquarters to increase space for manufacturing, research and development and other key functions. Cerapedics has hired more than 100 employees in Colorado in the last five years and plans to hire another 60 Colorado-based employees by the end of 2024.
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