31 Jul Cerapedics™ Announces Expansion of Headquarters to Support Growth of its Bone Graft Products
WESTMINSTER, Colo., July 19, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, announced today 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.”
i-FACTOR is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide™, and it is just one of two FDA approved Class III drug-device bone grafts with a spinal indication. i-FACTOR has proven statistical superiority vs. local autograft in overall success (defined as meeting Fusion, Function (Neck Disability Index), Neurological and Safety endpoints) at one and two-year endpoints for single-level Anterior Cervical Discectomy and Fusion.
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.
Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair by healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures worldwide. i-FACTOR is a Class III FDA approved product indicated for single-level ACDF. Cerapedics’ next-generation product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal clinical study, and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.
For more information, visit us at www.cerapedics.com.
To find out more news from the industry head over to our news section – orthocg.com/news