Surgeons in Europe can now treat patients with severe facial deformations using MyBone, a first of its kind patient specific 3D printed bone implant.
The bone consists of hydroxyapatite, a calcium phosphate which is the main mineral component of natural bone.
MyBone is 3D printed with a unique porous structure by Cerhum, a medical device company in Liège, Belgium, and is the first commercially available 3D printed bone graft, authorised under the Medical Device Regulation 2017/745 (MDR). The bone has been made available to a first batch of maxillofacial and orthopedic surgeons as a patient-specific implant. It is registered with the Belgium Competent Authority (FAMHP, registration number BE/CA01/1-72228) and ISO 13485 certified.
As part of a controlled release phase two years ago, a complex and challenging case was done in which a patient received a 3D printed implant specific to them. The patient is said to be doing well and on a recent CT scan the implant appeared exactly like natural bone.
Dr Christophe Ronsmans, Head of Department Plastic Surgery, CHR Liege, had this to say about the patient who received the implant two years ago: “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.”
Cerhum (CERamics for HUMans), was founded in 2016, and is a spinout from Sirris, the Belgian National Science and Technology Institute, and a partner of the University of Liège. Grégory Nolens, the Founder and CSO of Cerhum said: “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.”
Speaking about the benefits of the MyBone and its capabilities to previous implants, Nolens added: “Our 3D printed bone implants offer a unique, patented porous structure that allows ingrowth of blood vessels. As a result, MyBone has shown seven times faster bone ingrowth than currently available bone graft granules.”
The ability to design implants so precisely to match the complexity of facial defects in patients, and have the implant constructed of the same component as natural bone, which has been given a lot of positive feedback from maxillofacial surgeons, has allowed Cerhum to expand its portfolio into the dental and oncological market.