Our primary goal is to address the health complexities associated with tendon and ligament disorders, promoting rapid recovery for acute or chronic conditions.

• Improved Clinical Outcomes: The 4D hydrogel scaffold aims to reduce tissue healing time by 30% and surgical recovery time by 15% through the use of minimally invasive techniques (MIS).
• Functional Restoration: We seek to achieve tendon integrity by amplifying cell recruitment from surrounding tissues, which will drive extracellular matrix (ECM) production, effectively replacing compromised or absent tissue.
• Improved Quality of Life: Tendinopathies cause chronic pain and functional deficits, which affect patients’ psychological well-being. Faster recovery with a lower risk of relapse will support active ageing and improve quality of life.
• Social and Economic Savings: The loss of labour productivity due to complete Achilles tendon (AT) ruptures is estimated to cost an average of €6,900 per patient in EU countries, amounting to a total loss of €2.484 billion per year in the EU. By reducing relapses and accelerating recovery, TEN4CARE will significantly decrease this social burden.

TEN4CARE is also committed to Public and Patient Involvement (PPI) to ensure that innovation delivers the outcomes that matter most to end users and to promote societal trust in innovative therapies.

TEN4CARE will boost the EU’s industrial leadership in advanced materials and sustainable manufacturing technologies.

• Innovation in Medical Devices: We are developing an advanced, multipurpose medical device that is a game changer. This fibrous 4D nanocomposite hydrogel with shape memory will combine enhanced structural properties, antibacterial activity and regenerative capabilities driven by magnetic and electric fields (EMF/EMS).
• Advancement in Surgery: The shape memory design allows for implantation via minimally invasive surgery (MIS), a growing trend that offers better outcomes and fewer complications. This strengthens the widespread adoption of less invasive surgical procedures.
• Scalability and Digitalisation: We will obtain a GMP (Good Manufacturing Practices) validated production process coupled with an industrial-scale expansion strategy. This will be achieved through centrifugal spinning technology, which is a sustainable, cost-effective and high-performance alternative to techniques such as electrospinning.
• Digital Twin and Personalisation (AI): The development of an Artificial Intelligence (AI)-assisted Digital Twin will simulate and optimise the manufacturing process. In addition, the feasibility of a Digital Twin will be investigated to analyse MRI images of in vivo tendon injuries and simulate the 3D geometry of the scaffold, laying the foundation for a personalised treatment approach.
• Market Growth: The global tendon repair market, valued at USD 2.28 billion in 2023, is expected to grow to USD 5.11 billion by 2033. TEN4CARE will increase the EU’s market share, benefiting the industries involved.

TEN4CARE methodology includes pillars to ensure that the results are safe, sustainable and easily transferable to the clinical market.

• Safety and Sustainability by Design (SSbD): We will implement a detailed Safety and Sustainability assessment based on the SSbD concepts of the European Commission’s Joint Research Centre (JRC). This will guide our developments and generate general guidelines and discussion for the entire advanced materials sector in the medical field.
• Circular Economy and Materials: The project develops biodegradable and bioresorbable materials, contributing to the Circular Economy Action Plan and the Zero Pollution Action Plan. In addition, we ensure EU autonomy by using key raw materials (such as polycaprolactone, chitosan and chondroitin sulphate) that can be sourced from EU industrial suppliers.
• Robust Regulatory Strategy: We will provide early regulatory planning, including a regulatory roadmap for the sector. This includes defining the regulatory strategy for the device as a Class III implantable device incorporating a medicinal substance (anti-inflammatory drug) under the MDR/EMA.
• Complete Translation Package: TEN4CARE will conclude with the delivery of a complete translation support package. This package will integrate the regulatory roadmap, rigorous cost-benefit analysis (including the impact on QALYs) and business/exploitation models. This result will form the basis for attracting investors and ensuring a smooth transition to clinical phases and market adoption.