WESTMINSTER, Colo., July 19, 2023 /PRNewswire/ — Cerapedics Inc., a commercial-stage orthopedics firm devoted to redefining the usual of take care of bone restore, introduced at this time it’s increasing its headquarters within the Denver metro space to help the expansion of its merchandise, which embrace the U.S. Food and Drug Administration (FDA)-approved i-FACTOR® bone graft for cervical spinal fusion and its next-generation product at present being evaluated for lumbar spinal fusion.
“Because the launch of i-FACTOR, we’ve got seen a steady improve in its use in spinal fusion. We’re dedicated to supporting the wants of surgeons and their sufferers by increasing our facility,” stated Valeska Schroeder, Chief Government Officer of Cerapedics. “We’re lucky to be based mostly in Colorado and to recruit from the world’s skilled, innovation-focused expertise pool as we put together to launch our next-generation product.”
i-FACTOR is the one spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide™, and it is only one of two FDA authorised Class III drug-device bone grafts with a spinal indication. i-FACTOR has confirmed statistical superiority vs. native autograft in general success (outlined as assembly Fusion, Operate (Neck Incapacity Index), Neurological and Security endpoints) at one and two-year endpoints for single-level Anterior Cervical Discectomy and Fusion.
Cerapedics has absolutely enrolled its 290-patient randomized managed scientific research evaluating the security and efficacy of the next-generation P-15 Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgical procedure. This subsequent era product has been granted breakthrough standing by FDA and is being studied below an investigational machine exemption (IDE).
By increasing its facility, Cerapedics is including over 50 p.c more room to its Colorado headquarters to extend area for manufacturing, analysis and improvement and different key capabilities. Cerapedics has employed greater than 100 workers in Colorado within the final 5 years and plans to rent one other 60 Colorado-based workers by the tip of 2024.
About Cerapedics
Cerapedics is a world, commercial-stage orthopedics firm that aspires to redefine the usual of take care of bone restore by therapeutic bones quicker and at increased charges, with out compromising security, in order that sufferers can stay their healthiest lives. Bone grafts, together with Cerapedics’ merchandise, are utilized in over 4 million annual spine, orthopedics, trauma and interventional procedures worldwide. i-FACTOR is a Class III FDA authorised product indicated for single-level ACDF. Cerapedics’ next-generation product is at present being evaluated to be used in lumbar interbody fusion via ASPIRE, a pivotal scientific research, and has been granted a Breakthrough Machine Designation by the FDA. Cerapedics is headquartered in Westminster, CO.
For extra info, go to us at www.cerapedics.com.
Media contact: Ten Bridge Communications
TBCCerapedics@tenbridgecommunications.com
SOURCE Cerapedics Inc.
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