Each year in Europe, 1,6 million people require orthopaedic surgery after a bone, ligament or tendon injury. This number is projected to increase dramatically as the human life span, and involvement in high-activity sports continue to rise. And yet, there has been limited innovation in the field of orthopaedic surgery. For years, implant manufacturers have tried to perfect the surgical techniques and the design of their products made of metallic or bioresorbable materials, but their healing outcomes are imperfect. It leaves millions of European patients with fragilized bones and a ruined quality of life:
• Infection, inflammation or bone tissue destruction around the implant occurs for 30% of the patients ;
• 15% to 20% of the patients, within 18 months following the first surgery, will undergo a second surgery to remove a non-resorbable implant or to solve implant rejection;
• Post-surgical skeletal pain interferes with effective rehabilitation and bone healing, especially for the severely injured and the elderly, and lead to the development of chronic skeletal pain;
• This chronic pain is treated with nonsteroidal drugs and opiates with unwanted side effects ;
• Over 100 million Europeans suffer from Musculo-Skeletal-Disorders (MSDs) as a result of a bone injury. The community subsequently bears billions of follow-up costs each year, including re-operation costs and costs for chronic pain. The situation is similar in ageing populations outside Europe.
Enter NORAKER’s biocomposite surgical implants, made of bioactive glass – a revolutionary bioresorbable ceramic – mixed with a synthetic bioresorbable polymer. Unlike any other implant, this technology shows disruptive bone regeneration properties and proves able to recreate up to 100% of the native-like functional structure of the patient’s bone with no inflammation6 (for 99% of patients), no abnormal pain6 (no pain at all for 95% of patients) and a very low re-operation rate of 4% . No MSD is projected to come out of such a surgery.
NORAKER’s latest technology and patented process are already dedicated for use in one single indication: knee cruciate ligament injury. In 2015, the company has marketed the world-first biocomposite resorbable implant for this indication. NORAKER has achieved in 2018 a revenue of 1,6 M€. In 2018, in a SME Instrument Phase 1 project , NORAKER has validated the feasibility of a new biocomposite formula for use in many more indications (such as shoulder, ankle, elbow, wrist and long bones). The goal of the present Phase 2 project is to do the industrial scale-up and launch the industrial production of implants for these multiple indications. Adoption of these implants will support the transition toward bone regeneration surgery and bring an end to the damaging spiral of pain, infection, re-operation and MSDs. With this disruptive offer, NORAKER will become a scale-up operating worldwide, with a production, sales capacity and turnover multiplied by 15 in five years.
