Dutch PEEK 3D printing startup Bond3D and medical implant developer Invibio Biomaterial Solutions have successfully developed a method of additively manufacturing spinal fusion cages to better facilitate patient recovery.
The "next-generation" spinal fusion device developed by the two companies not only has all the therapeutic advantages of its predecessor but can also be configured with the porosity needed to stimulate new bone formation. At Formnext, the companies' mesh structures are also said to be biocompatible enough to be approved by the U.S. Food and Drug Administration, which they are currently going through the regulatory steps to gain.
△CT image of mesh spinal fusion cage printed by Bond3D
Bond3D's PEEK 3D printing technology
Operating from its base in Enschede, Bond3D specializes in the production of functional components from high-performance polymers that are certified for end-use in critical applications. The company's operations revolve around a patented pressure-controlled extrusion process in which filaments can be printed in layers, resulting in a final part with a density greater than 99 percent .
This technology enables Bond3D to address the medical, aerospace, energy, and automotive markets due to compatibility with materials such as polyimides, fluoropolymers, liquid crystalline polymers and polyaryletherketones (PAEKs).
To help it further develop its unique extrusion method, Bond3D received funding from Victrex in 2019, said to be worth "several million euros". Since then, the company has continued to refine the technology, unveiling its void-free PEEK 3D printing process last year and announcing eight production-ready systems.
△Bond3D's 3D-printed PEEK spinal fusion cage
Given that PEEK is sterilizable, highly biocompatible, and has an impressive strength-to-weight ratio, it has proven to be a popular material in the medical industry. In fact, according to Bond3D, the polymer has been used to create implants for more than 15 million patients, whether they need orthopedic, spinal, trauma, or cardiovascular treatments.
Bond3D identified an opportunity in this area to develop spinal intervertebral fusions that allow for clearer, artifact-free CT/MRI imaging. According to the company, producing implants with a modulus similar to natural bone, porous regions that promote bone growth, and rigidity that prevents mesh collapse also remains an ongoing challenge in the field of biomedical devices.
To address these issues related to imaging and stiffness, Bond3D partnered with Invibio Biomaterials to develop the ability to 3D print high-porosity spinal cages. Bond3D says its technology allows for the creation of "fourth generation" implants that combine all the advantages of previous generations with enhanced biomechanics and biocompatibility to aid in bone regeneration.
The two companies are now taking the final steps to submit an FDA application for one of these devices to a spinal implant developer in the United States. Bond3D says the file will help any subsequent medical OEMs bring their designs to market in the future.
While 3D printing is still finding its footing in the broader medical market, the technology has already caught on in the manufacture of custom spinal implants. 4WEB Medical now sells a complete line of these devices, including its self-contained anterior spinal truss system, intended for use during the treatment of spinal conditions.
Back in 2018, Johnson & Johnson acquired EIT, a move that also gave the American multinational a strong foothold in the 3D printing of spinal implants. At the time, the deal was said to bolster Johnson & Johnson's orthopedic arm DePuySynthes' intervertebral implant portfolio, which includes titanium-integrated PEEK devices designed for minimally invasive procedures.