Rebooting bone regeneration
Orthopaedic surgery plays a crucial role in the lives of millions of Europeans, with 1.6 million individuals requiring surgery annually due to bone, ligament or tendon injuries. However, the existing orthopaedic procedures using metallic or bioresorbable implants often result in imperfect healing outcomes, leading to complications such as infection, inflammation, chronic pain and a significant economic burden on healthcare systems. Furthermore, 15-20 % require a second surgery within 18 months, leading to chronic skeletal pain treated with drugs that may have undesirable side effects.
Disruptive bone-regenerative technology
In response to these challenges, the EU-funded REBOOT project, led by NORAKER, introduces a groundbreaking solution using biocomposite surgical implants made of bioactive glass (Bioglass®) and synthetic bioresorbable polymers. NORAKER's Bioglass® technology(opens in new window) utilises bioactive glass(opens in new window) 45S5 ceramic, ensuring optimum safety, biocompatibility and a reduced risk of pathogen transmission. “Our innovative technology demonstrates disruptive bone regeneration properties, achieving healing outcomes that surpass those of traditional implants,” explains project coordinator Céline Saint Olive. The journey towards Bioglass® began with the pioneering work of Larry L. Hench in the late 1960s. Fuelled by a need for materials that could seamlessly bond with bone, Hench's inspiration came from amputations resulting from the body's rejection of metal implants in Vietnam. Successful rat femur implantation marked the birth of bioactive glass, setting the stage for NORAKER's cutting-edge Bioglass® technology.
Bioglass® mode of action
Upon implantation, Bioglass® initiates integration by exchanging calcium and sodium ions with bodily fluids, forming a silica-gel layer. This is followed by the development of another layer that mirrors natural bone. Growth factors attracted to Bioglass's surface activate resident macrophages, prompting migration of osteoprogenitor cells which attach to the bone and differentiate into bone-producing osteoblasts. Throughout, Bioglass® degrades, transforming into new extracellular matrix material – fostering continuous bone growth and repair in a natural and seamless process. In a convenient and applicable form, Bioglass® is available in a syringe, ensuring optimal safety during implantation and facilitating natural and effective bone regeneration.
Technology advancements
The key objective of the REBOOT project was to advance the technology in terms of manufacturing, prototyping and industrial production scalability. The team improved processability and injectability of the biocomposite, allowing for implant designs as small as 1 mm wide. The injection precision was increased tenfold, enabling broader applications, especially on small joints. Prototypes of shoulder and knee implants were successfully manufactured, even for challenging cases with small/large dimensions and complex geometries. In vivo testing demonstrated positive results for safety and performance, showcasing bone regeneration superior to state-of-the-art implants. These results also confirmed compliance with medical device regulations, with the team streamlining the regulatory process by proposing a single biocomposite formula.
Future directions
Looking ahead, the project will continue to successfully engage with stakeholders, and pursue FDA and CE certifications. Moreover, the team plans to expand the production capacity to meet the increasing demand for biocomposite implants. NORAKER envisions a transformative impact on orthopaedic surgery, contributing significantly to improved quality of life for millions of patients worldwide.
