Several months after earning FDA clearance, a 3D-printed bone graft product is gaining steam, having now been used in a handful of surgical procedures.
The product in question is CMFlex, which was developed by Dimension Inx. It’s a synthetic bone graft material that’s customized to each individual patient and, once implanted, is designed to promote natural regeneration of the nearby bones.
CMFlex was cleared by the FDA in December 2022, making it the first 3D-printed regenerative bone graft product to earn a green light from the regulator. It’s indicated for use in surgeries to correct maxillofacial, mandibular and dental bone defects.
The synthetic material has now been used across all of those indications, according to an announcement this week from Desktop Health, maker of the 3D printer used to churn out CMFlex.
The first upper and lower jaw surgeries took place in North Carolina and Connecticut, while an Illinois-based oral surgeon has also used CMFlex in several dental socket preservation surgeries ahead of future dental implant placements.
The bone graft product is currently available only to a handful of surgeons, but Dimension is planning to increase its reach throughout 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,” Adam Jakus, Ph.D., Dimension’s co-founder and CTO, said in the announcement.
“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,” he added.
CMFlex is made from a material developed by Dimension and dubbed Hyperelastic Bone. It’s a combination of particles of the natural mineral hydroxyapatite and a biodegradable polylactide-co-glycolide (PLG) polymer, which together create a material that’s designed to integrate well into the human body and encourage its own replacement with regenerating bone. The material is also absorbent and can therefore help the body reach hemostasis by controlling bleeding during surgical procedures, according to its maker.
Dimension uses Desktop’s 3D-Bioplotter machines to 3D print the material into the CMFlex bone grafts, which can be precisely sized to each patient.
In a statement shared by Dimension last month, Derek Steinbacher, M.D., who performed the Connecticut-based surgery, attested that CMFlex “boasts excellent handling characteristics, and the fact it can also be cut and trimmed to easily match the defect site made it an exceptional product to work with.” North Carolina-based Brian Farrell, D.D.S., M.D., meanwhile, praised how “the material was easy to contour.”