Dimension Inx Introduces FDA-Cleared CMFlex™ 3D-Printed Bone Graft in Surgery
Thursday, October 05, 2023
Dimension Inx, a cutting-edge biomaterials platform company, recently marked a significant achievement with the successful use of CMFlex™. It is the first 3D-printed regenerative bone graft product to receive FDA approval, employed in clinical cases.
CMFlex is a synthetic bone graft designed for addressing bony defects in oral and maxillofacial surgical procedures. It comprises hydroxyapatite particles and biodegradable polylactide-co-glycolide (PLG) polymer, both renowned for their biocompatibility and clinical efficacy.
Dimension Inx's groundbreaking approach combines these base materials to create a unique microstructurally porous composite material named Hyperelastic Bone®. This distinctive bone repair material is then transformed into CMFlex using 3D printing technology. What sets it apart is its adaptability, allowing surgeons to customize it for each patient. Additionally, CMFlex can absorb fluids, aiding in surgical hemostasis and supporting bone remodeling after implantation.
These initial clinical cases herald a new era of biomaterials and underscore Dimension Inx's remarkable technology platform's potential. It rapidly generates biomaterials that guide cell behavior to restore tissue and organ function. This achievement reflects the value of innovative biomaterial design and 3D printing techniques.