Bioceramic Bone Tissue Printer CeraPrint Receives FDA Approval: Printing Implantable Bones Using Patients' Own Cells

Bioceramic Bone Tissue Printer CeraPrint Receives FDA Approval: Printing Implantable Bones Using Patients' Own Cells

Organovo today announced that its bioceramic bone tissue printer CeraPrint has received FDA 510(k) approval. The device can mix a patient's mesenchymal stem cells with hydroxyapatite bioceramic material and use extrusion-based 3D printing technology to manufacture customized bone tissue grafts.

CeraPrint's workflow: extract mesenchymal stem cells from the patient's bone marrow, expand them in vitro, mix them with bioceramic ink, and print bone tissue precisely matching the defect site based on CT scan data. After printing, the graft is cultured in a bioreactor for 14 days until the cells have sufficiently proliferated and differentiated before implantation.

In clinical trials, CeraPrint was used for bone defect repair after tumor resection in 28 cases. At 12 months post-surgery, the osseointegration success rate was 93%, significantly higher than the 78% for traditional titanium alloy implants.

Organovo CEO Mike Renard said: "CeraPrint achieves the ultimate goal of orthopedic repair — rebuilding a patient's own bone using their own cells. The implant not only matches in form but is also bioactive, capable of remodeling and strengthening over time."

The CeraPrint device is priced at $850,000, with single-use printing consumables costing approximately $5,000. The first devices will be deployed at 20 top orthopedic centers across the United States.