Two years ago at a medical 3D printing event where I served as a moderator, one of the presenters explained that applications of 3D printed patient specific solutions were very much needed to facilitate the work of the surgeon and accelerate the recovery time for the patient. The thing is those patient-specific implants needed to be developed first for specific parts of the body, and be approved by medical authorities. And this latest part is often the Holy Grail for most medical technology companies.
One of the companies that has recently addressed these hurdles is Cerhum, a medical device company that developed 3D printed bone grafts. Founded and led by Gregory Nolens, Cerhum appeared on our radar last year when it signed a partnership with 3DCeram.
The Belgium-based company has recently developed a patient specific 3D printed bone, to treat patients with severe facial deformations. Named MyBone, 3D printed bone is made of hydroxyapatite, a calcium phosphate which is the main mineral component of natural bone.
Available for Europe-based surgeons, it is 3D printed with a unique porous structure and is the first commercially available 3D printed bone graft authorised under the Medical Device Regulation 2017/745 (MDR), registered with the Belgium Competent Authority (FAMHP, registration number BE/CA01/1-72228) and ISO 13485 certified, a press communication reads.
MyBone is made available to a first batch of maxillofacial and orthopaedic surgeons as a patient-specific implant. For example, 2 years ago, as part of a controlled release phase, a complex and challenging case was done in which a patient received such a 3D printed bone implant. The patient is doing excellent and the implant looks exactly like natural bone on a recent CT scan, Cerhum explains.
“Given the complexity of the defect, it would have been impossible to achieve such perfection from an aesthetic point of view and such a functional result with current methods“, Dr Christophe Ronsmans, Head of Department Plastic surgery, CHR Liege comments.
“We are very proud to have successfully gathered vital clinical data and passed all the regulatory hurdles with a synthetic bone graft that is safe and effective. Our 3D printed bone implants offer a unique, patented porous structure that allows ingrowth of blood vessels. This process, called vascularisation is key to achieve successful bone ingrowth. As a result, MyBone has shown 7x faster bone ingrowth than currently available bone graft granules. Due to extremely positive feedback of maxillofacial surgeons so far, Cerhum is expanding its portfolio into the dental and oncological market”, Grégory Nolens, Cerhum Founder and CSO concludes.
Read more about failure mechanisms of biological structural materials, such as bone and nacre.
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