Dimension Inx CMFlex Pioneers Surgeries as FDA’s First Cleared 3D Printed Bone Graft

Marking a new milestone in 3D printed medical innovation, the first 3D printed regenerative bone graft product is now making its way into surgeries, offering a pioneering solution for bone repair. Made by Dimension Inx, CMFlex is an off-the-shelf, customizable bone graft material cleared by the U.S. Food and Drug Administration (FDA) in December 2022. Manufactured using the Desktop Health 3D-Bioplotter Manufacturer Series model, CMFlex has been successfully used in two patient jaw surgeries, an upper and lower jaw, and several dental socket preservation cases.

Desktop Health has announced the first patient treatments using CMFlex, the production-grade medical 3D printing brand of Desktop Metal (NYSE: DM). According to the brand, the first jaw cases were performed by maxillofacial surgeon Derek Steinbacher, the Director of West River Surgery Center and Professor of Plastic surgery and Chief of Oral and Maxillofacial surgery at Yale New Haven Health in Connecticut, and orthognathic (jaw) surgeon Dr. Brian Farrell of the Carolinas Center for Oral & Facial Surgery in North Carolina. Meanwhile, other procedures performed included mandibular angle augmentation, which is the surgery of the lower jaw, and maxillary segmental osteotomy, which refers to the surgery of the upper jaw.

CMFlex has also been used in dental socket preservation surgeries for future dental implant placement by oral surgeon Dr. Robert Bosack, who serves in Illinois’ Oral, Maxillofacial & Dental Implant Surgery. Although CMFlex is currently available to a limited number of key surgeons, it will gain a broader release later in 2024.

“These first cases are not only indicative of a new generation of biomaterials but also highlight our technology platform’s unique capability to rapidly create biomaterials that direct cell behavior to restore tissue and organ function. It is a proud moment for us to be able to demonstrate the value of therapeutics derived from integrating novel biomaterial design and 3D-printing approaches,” said Adam Jakus, who is Chief Technology Officer, Head of Technology Strategy, and Dimension Inx co-founder.

Dimension Inx’s CMFlex is an off-the-shelf 3D printed synthetic bone graft. Image courtesy of Business Wire.

One of the major benefits of CMFlex is its ability to eliminate the need for invasive procedures to harvest bone from another area of a patient’s body. This not only reduces the risk and complexity of surgeries but also improves patient comfort and recovery time. The material is customizable and can be shaped to fit specific anatomical requirements, making it a highly adaptable solution for various bone grafting needs. This innovative product marks a new era in medical treatments for bone defects, particularly in maxillofacial, mandibular, and dental applications.

Designed to encourage natural bone regeneration, CMFlex is an ideal solution in bone repair and regenerative medicine. Its material composition includes hydroxyapatite, a naturally occurring mineral in bone, combined with a biodegradable polylactide-co-glycolide (PLG) polymer. This composite, known as Hyperelastic Bone, is 3D printed into the final CMFlex product using Desktop Health’s 3D-Bioplotter Manufacturing Series model. Initially launched in 2000, the 3D-Bioplotter is the most seasoned bioprinter in the market, backed by more than 600 research papers. It can process a range of materials with high precision, which is crucial for the complex requirements of medical applications.

3D-Bioplotter Manufacturer Series. Image courtesy of Desktop Health.

Designed as a tool for advanced tissue engineering and also for use in a production environment, the 3D-Bioplotter Manufacturer Series is the most versatile and developed of the three 3D-Bioplotter options and is capable of running up to five materials in a build as well as UV curing capabilities and both heated and cooled platform options. Dimension Inx owns four Desktop Health 3D-Bioplotters; two are used for R&D, and two are used for manufacturing their commercial CMFlex product.

Launching CMFlex represented a significant milestone in the field of bioprinting. Dimension Inx and Desktop Health are at the forefront of this technology, driving innovation and the application of 3D printing in medicine. Furthermore, the successful clinical use of CMFlex paves the way for further advancements and applications of bioprinting in healthcare.

Looking ahead, the introduction of CMFlex into clinical practice is just the beginning of a new era in medical treatment. As Dimension Inx and Desktop Health continue to explore the possibilities of 3D printing in medicine, the potential for more groundbreaking products and treatments is immense. Although still in its launch period, CMFlex’s recent success in the OR sets a new standard in regenerative therapeutics, offering a little hope for this new range of advanced solutions for patients with bone defects.