Skip to main content
European Commission logo print header

First-in-class implants for bone regeneration surgery after a bone, ligament or tendon injury

Periodic Reporting for period 3 - REBOOT (First-in-class implants for bone regeneration surgery after a bone, ligament or tendon injury)

Reporting period: 2021-11-01 to 2022-10-31

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.
Specific objective 1: Do the industrial scale-up of the biocomposite production and drive new implant designs (addressed in WP1).

NORAKER has increased the processability and injectability of the biocomposite (injectability multiplied by 10 in order to target all indications, especially on small joints). The new injection technology enable to develop new implant designs (down to 1mm width) and finalize their specifications.
NORAKER developped a new capacity to produce the granules of biocomposite, manufactured the molds. The injection according to the newly-defined specifications has been delayed because of the lockdown in France for several months (explained in details later in the document).


Specific objective 2: Industrialize the manufacturing process and produce a first line of biocomposite implants (addressed in WP2)

NORAKER has manufactured prototypes and test the process on implants, which have been flagged as “most-wanted” in the market study performed during the SME Instrument Phase 1: shoulder and knee implants.


Specific objective 3: Implement a tailored regulatory strategy, where NORAKER will request mutualized market authorization for a “pool” of implants instead of a “one by one” procedure

The biocompatibility assessment is a major requirement in the technical file for medical devices: in vivo implantations in animals must be conducted in the case of the release of a new medical device on the market. In vivo testings will start in March 2021, with a 6 months delat according to the initial plan (explained in details in the document).

There will be one single biocomposite formula for all the implants produced, so NORAKER will request that the biocompatibility assessment made on the first-developed REBOOT implant becomes a base element for all subsequent technical files.


Specific objective 4: Build a tailored dissemination and exploitation framework for global market uptake

In 2018, NORAKER achieved a revenue of 1,6M€, selling in France in more than 50 public and private hospitals and having a network of specialized representatives in more than 15 countries, in Europe, Latin America, Asia and Middle East.
In 2020, NORAKER dramatically strengthened its business network with the REBOOT implants, as end-users are the same specialized representatives and surgeons as the current implants of NORAKER. The complete range of implants of NORAKER will also be very attractive to new experienced representatives worldwide.
NORAKER achieved major milestones regarding business development, by completing the registration of the current projects in key countries: Brazil, India and Australia. The sales in the major countrie started right away thanks to string local partners, and could compensate the lockdown and cancelation of elective surgeries in France and Europe.
NORAKER continued to invest in scientific and clinical communication and marketing, by hosting events at major international congresses and medical fairs; and by collaborating with surgeons to publish their clinical studies in international peer-reviewed papers. Even though most events were cancelled, NORAKER developed a on-line strategy of webinars to train surgeons and reach new customers.
anchor of REBOOT