Dimension Inx, a biomaterials platform company, announced that CMFlex, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases.
The first two cases were performed by Dr. Derek Steinbacher, Director of West River Surgery Center, Former Professor of Plastic surgery and Chief of Oral and Maxillofacial surgery at Yale New Haven Health and Dr. Brian Farrell, DDS, MD, of the Carolinas Center for Oral & Facial Surgery. Procedures performed included a mandibular angle augmentation (surgery of the lower jaw) and maxillary segmental osteotomy (surgery of the upper jaw).
CMFlex is a 3D-printed synthetic bone graft used for various bony defects in oral and maxillofacial surgical applications. CMFlex utilizes a chemistry comprised primarily of hydroxyapatite particles combined with biodegradable polylactide-co-glycolide (PLG) polymer. Both materials have an extensive history demonstrating biocompatibility and clinical utility. Dimension Inx combines these base materials into a proprietary, microstructurally porous composite material, Hyperelastic Bone, as first published in Science Translational Medicine in 2016. This unique, easily deployable bone repair material is then 3D-printed into CMFlex. The resulting product is one that surgeons can size for each patient and is uniquely capable of absorbing fluid, which enables it to control bleeding during surgery while assisting the bone remodeling process once implanted.
Dimension Inx received FDA clearance of CMFlex in December of 2022. CMFlex is currently available to a limited number of key surgeons with a broader release to follow later in 2024.
