Oxford Performance Materials, Inc. (OPM), a leader in advanced materials science and high performance additive manufacturing (HPAM), today announced that it has received a Notice of Decision to Grant a Patent from the European Patent Office (EPO) for OPM’s invention on a “Customized Implant for Bone Replacement”, which leverages its OsteoFab implant manufacturing process, originally filed on December 5, 2011. The patent, which took effect on December 21, 2016, will be valid until August 7, 2029, and enables OPM to apply its high-performance additive manufacturing process to 3D print customized implants for bone replacement.
This fundamental patent protects OPM’s novel OsteoFab process for manufacturing a three-dimensional object from poly-ether-ketone-ketone (“PEKK”) powders through selective laser sintering (SLS). OPM utilizes the OsteoFab® process, which combines 3D printing with a unique material chemistry, to print orthopedic and neurological implants that possess unique and beneficial attributes, including radiolucency, bone-like mechanical properties, and a distinctive “peak-and-pit like” surface topography.
“This patent from the EPO is an important milestone for OPM as it allows us to further expand into Europe with validated process technology that enables the 3D printing of fully functional, patient-specific parts for biomedical applications. Our biomedical innovations are enabling improved surgical outcomes at a lower cost, causing the industry to rethink how surgical implants are designed and manufactured. We look forward to delivering improved personalized medicine to the European market.” Severine Zygmont, President of OPM Biomedical.
OPM Biomedical is a pioneer in personalized medicine, 3D printing OsteoFab cranial and facial implants as an OEM, and its SpineFab line on a contract manufacturing basis. OPM Biomedical is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has a total of four 510(k) clearances in its portfolio.
OPM’s medical devices that utilize the company’s OsteoFab process, which combines laser sintering additive manufacturing technology and OPM’s proprietary OXPEKK material formulation to 3D print orthopedic and neurological implants.
The rising cost of healthcare is a global issue that cannot be ignored. The adoption of our OsteoFab implants over metallic and other polymeric options appears to be driven by a combination of 3D printing technology attributes: desirable economics, biocompatibility, radiolucency, and bone-like mechanics and behavior. Studies have shown that our OXPEKK 3D printed formulation exhibits osteoconductive characteristics – meaning bone grows onto the micro-textured surface, providing technology for bone fixation.
OPM also provides contract manufacturing services to 3D print OsteoFab implants from approved design files from customers worldwide. An exciting aspect of OPM’S OsteoFab technology is that additional complexity does not increase manufacturing cost. As a result, additive manufacturing has the potential to not only improve patient outcomes, but also fundamentally improve the economics of orthopedics on a global scale – for developed and developing countries. These are disruptive changes that could allow the industry to provide the finest levels of healthcare to more people at lower cost.