icotec Receives FDA Clearance for the CMORE® CT System, Expanding its BlackArmor® Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine

ALTSTÄTTEN, Switzerland and BOSTON, Nov. 13, 2025 /PRNewswire/ -- icotec, the pioneer of implantable devices made from BlackArmor^® Engineered Carbon/PEEK, today announced that the U.S. Food and Drug Administration (FDA) has cleared the CMORE^® CT System for use in the cervicothoracic spine.

The CMORE^® (CT) System is an enhanced set of instruments and implants for posterior stabilization of the upper spine. The world's first spinal implants made of nonmetallic and radiolucent BlackArmor^® technology now enable a full spectrum of treatment modalities in adjuvant tumor therapy and enhance postoperative imaging diagnostics in the cervicothoracic spine. Consisting of a full portfolio of polyaxial screws, straight and precontoured rods, axial and parallel connectors, the CMORE^® CT System provides the versatility needed to accommodate variations in patients' anatomy and pathology.

BlackArmor^® Engineered Carbon/PEEK is a combination composite material with continuous, high strength carbon-fibers and PEEK, manufactured in a process developed by icotec. The result is an implant component with an interwoven 3D fiber architecture. It is also radiolucent in all diagnostic imaging modes (MRI, CT, and X-ray).

"The FDA clearance of the CMORE^® CT System marks another milestone in our commitment to advancing care for patients with spinal tumors, infections, and complex pathologies," said Christoph Eigenmann, CEO of icotec Medical, U.S. "By expanding our BlackArmor^® technology to the posterior cervical spine, we're giving surgeons and radiation oncologists a new level of visibility and confidence in their postoperative and oncological decision-making."

icotec is excited for the upcoming commercial launch of the CMORE^® CT System in the United States. This system will expand icotec's portfolio of BlackArmor^® Engineered Carbon/PEEK implants designed for artifact-free imaging and seamless integration across the spine.

About icotec

icotec is the leading company for the treatment of spinal tumors and other indications with a new generation of high-tech implants. With its BlackArmor^® Engineered Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients and is dedicated to advancing the field of spinal implantation.

With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery. The comprehensive product portfolio has received FDA and CE clearance and is supported by numerous Key Opinion Leaders and spine surgery centers worldwide.

Media Contact: 

Craig Wencis

Senior Vice President of Marketing and Education

craig.wencis@icotec-medical.com

For more information, visit www.icotec-medical.com

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