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Patient-specific bone grafts are emerging as a viable option to treat genetic deformities and repair defects caused by trauma or disease. The additively manufactured synthetic implants closely resemble the performance and function of natural bone, match the clinical needs of individual patients and feature surgeon-friendly designs that can reduce surgical times.
With these benefits in mind, companies that specialize in 3D printing are producing bone-like implants with the potential to reshape personalized patient care. It’s a growth opportunity in the orthopedic market worth monitoring as 3D printing technology evolves and adoption among surgeons increases.
Perfecting the Production Process
Cerhum, a 3D printing company in Belgium, is focused on producing grafts that perfectly match the craniomaxillofacial defects of individual patients. The company specializes in working with bioceramic materials, particularly hydroxyapatite, which closely resembles the components of natural bone.
The company’s additively manufactured MyBone implant is the first commercially available 3D-printed bone graft authorized under EU MDR. It’s made of hydroxyapatite, a biocompatible synthetic that precisely matches an individual patient’s bone defect. The implant features interconnected internal channels, a design that cannot be made with conventional manufacturing.
These channels create over 60% of open space, facilitating the growth and colonization of blood vessels throughout the bone graft material. As a result, the more the graft integrates with the patient’s body, the greater the bone in-growth and the better the long-term outcomes.
The graft’s optimized structure and internal channels significantly accelerate the growth of blood vessels, as evidenced by studies that show bone growth up to seven times faster than conventional bone grafts.
“This groundbreaking design is advancing the field of bone implants and offering superior results for patients,” said Valentin Henriet, Cerhum’s Operations Manager.
Cerhum receives scans of patients’ specific bone defects from surgeons and returns personalized implants in four to six weeks. Henriet acknowledged the increasing importance of patient-specific implants and personalized medicine in orthopedics — and why both provide advantages over current standards of care.
“They streamline decision-making and reduce surgical workloads,” he said. “Additionally, surgeons are given perfectly sized grafts to fill bone defects.”
To produce MyBone implants, Cerhum acquires raw hydroxyapatite powder and mixes it with various resins and polymers. This combination forms a slurry, which is then fed into a 3D printer. The printing process begins by spreading a small amount of slurry on the top layer’s printing plate.
UV light is applied to the layer, causing it to solidify. The printing plate then lowers, and a new layer of the slurry is spread on top of a second plate. UV polymerization creates the implant’s next layer. This layer-by-layer process continues until the implant is formed.
The ceramic mixture of polymers and hydroxyapatite requires post-processing to complete the production process. After printing, the bioceramic material undergoes a terminal treatment to remove the remaining polymers from the structure. This process also allows the material to densify and become more resistant.
“A significant achievement is our ability to 3D print bioceramics with exceptional precision, which is a challenging task,” Henriet said. “We have also conducted extensive clinical validations for patients. That’s a lengthy and costly process.”
Streamlined Surgical Care
The creation of personalized implants is aligned with the digitization of orthopedic care. “With increased processing power, surgical planning has become more precise, enabling surgeons to know exactly what needs to be done — and what kinds of implants they need — in advance of procedures,” Henriet said.
Autograft implants, which are the current standard of care in orthopedic surgery, are associated with higher morbidities and prolonged hospital stays.
“This results in significant costs for the hospital and the health system,” Henriet said. “These challenges emphasize the importance of combining the development of synthetic bone grafts and 3D printing, which are becoming increasingly popular as they offer superior benefits for both surgeons and patients.”
Procedures are more complex and time-consuming when orthopedic surgeons work with off-the-shelf implants, Henriet noted.
“It requires two surgical teams — one to open the patient and prepare the graft through manual sampling and shaping, and another to place the graft,” Henriet said. “This process almost doubles the surgery time and may not yield the results that can be achieved through precise preoperative planning and personalized implants.”
With patient-specific implants, the surgical process becomes much more streamlined. “The surgeon opens the patient, places the perfectly designed graft, secures it with screws and closes the wound,” Henriet said. “This efficient process typically takes around one to one-and-a-half hours to complete.”
Exploring New Applications
Spine surgery is another potential application of the additively manufactured MyBone technology. “It offers the advantage of creating various small cages involving different angles,” Henriet said. “This approach caters to the diverse shapes required in spine surgery and presents a considerable market opportunity.”
Cerhum is also actively working to develop different types of bone grafts for the treatment of pseudoarthrosis and fracture repair and the filling of large bone defects. “The main challenges for these applications relate to force loading and mechanical resistance, which I am currently investigating,” Henriet said.
Hydroxyapatite is a non-resorbable ceramic material. Henriet believes 3D printing could evolve to produce resorbable implants. “Eventually, the patient’s body incorporates the graft, leaving only their own bone in its place,” he said. “This is considered the optimal outcome, as there is no foreign material left inside the body.”
Henriet said Cerhum is also exploring the possibility of combining polymers and ceramics to produce more elastic bone grafts. “This would open up new opportunities to tailor the grafts to specific patient needs and clinical applications,” he said.
Overcoming Future Challenges
In February, Chicago-based Dimension Inx raised $12 million in Series A funding to expand its additive manufacturing capabilities and support the commercial launch of CMFlex, a 3D-printed bone graft — the first of its kind cleared by FDA — made of calcium phosphate and minority poly (lactide-co-glycolide).
The company hopes to market the product this year, according to Adam Jakus, Ph.D., co-founder and Chief Technology Officer of Dimension Inx. “We have not yet obtained initial clearance for patient-matched applications,” he said. “Currently, we offer off-the-shelf shapes with simple geometries.”
Despite not being specifically manufactured for individual patients, CMFlex is a versatile and user-friendly solution that surgeons can adapt to the needs of individual patients, according to Dr. Jakus. “It can be cut and trimmed to suit the needs of individual patients,” he said. “This adaptability allows surgeons to customize the material to some extent for a better fit.”
From a technical standpoint, achieving patient-matched 3D printing is feasible today. “However, the process requires obtaining regulatory clearance, which can take several years,” Dr. Jankus said. “Regulatory bodies like FDA not only review the final product but also assess the entire manufacturing process, including image acquisition, modifications made by radiologists or 3D printing engineers, and the actual printing procedure.”
Making the business case for patient-matched implants also remains a significant obstacle, Dr. Jankus noted. “Traditional mass-produced implants are relatively cost-effective and have been widely used for decades,” he said. “Introducing a fully customized approach for every patient may not be economically viable for large orthopedic companies, particularly if it does not significantly impact their profit margins.”
However, there is a growing need for 3D-printed implants in orthopedic surgery, especially for complex procedures.
“As procedures become more intricate, the demand for specialized solutions increases,” Dr. Jankus said. “While off-the-shelf options will always have a place in the market, patient-matched implants are likely to see increased adoption in the coming years.”
