Xtend U – An Amputee solution for a life without pain, blisters and infections

Informations projet

XTEND U

N° de convention de subvention: 190163665

DOI

10.3030/190163665

Projet clôturé

Date de signature de la CE 14 Decembre 2022

Date de début 1 Janvier 2023

Date de fin 31 Decembre 2025

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 2 351 596,25

Contribution de l’UE

€ 1 646 117,00

Coordonné par

C LINDHEXTEND AKTIEBOLAG
Sweden

Periodic Reporting for period 3 - XTEND U (Xtend U – An Amputee solution for a life without pain, blisters and infections)

Période du rapport: 2025-01-01 au 2025-12-31

Résumé du contexte et des objectifs généraux du projet

Xtend U-190163665

Xtend U addresses one of the most frequent challenges for prosthetic users: heat and moisture buildup inside the socket, which affects comfort, skin health, and daily mobility. The project aimed to deliver a prosthetic liner that improves the stump microclimate while functioning as a reliable everyday liner.
From 2023–2025, the work focused on refining the design, validating performance, and preparing the solution for regulatory approval and market readiness. A clinical investigation has shown strong user benefits, and preparations for full serial production are in place. The project also identified new opportunities for intellectual property protection, strengthening long‑term impact and competitiveness.

www.lindhextend.com

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Xtend U

During the project period, the team conducted extensive prototyping and iterative material development to optimise the Xtend U liner’s structure, absorption performance and compatibility with existing prosthetic sockets. Multiple prototype batches were produced, and short‑term laboratory testing helped refine the balance between superabsorbent content, fabric construction, and overall thickness. Mechanical characterisation—including abrasion, tensile and burst testing—was carried out and showed performance levels in line with conventional liner materials.

The project also explored and evaluated several alternative concepts for achieving adequate cushioning and optimised external sealing properties. These investigations supported decisions for the next development steps while ensuring that retrofit compatibility and user comfort remained central design requirements.

In parallel, the team developed and validated methods to measure humidity in the liner–skin interface. Various sensor orientations were tested, and a reliable measurement approach was established, enabling consistent assessment of the liner’s microclimate performance.

The clinical investigation was completed with positive outcomes that supported the intended function of the Xtend U liner. In the final phase of the project, preparations for transition to full serial production were concluded, including materials validation, refinement of manufacturing processes and readiness for scale‑up

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The project finalised the serial production design of the Xtend U liner, including complete engineering documentation and validated manufacturing tolerances.

Production readiness was demonstrated through successful manufacturing runs that confirmed robustness and repeatability. Internal verification and validation activities showed that the technology reached the expected maturity for transfer to high‑volume production.

The clinical investigation at Sahlgrenska University Hospital was completed with strong results: the Xtend U liner significantly reduced skin‑liner humidity compared to conventional liners, met its intended clinical purpose, and showed no safety concerns. The validated study methodology supports future regulatory and scientific work.

Significant progress was achieved toward industrialisation, including supplier qualification, process optimisation and preparation for scale‑up. While full TRL8 with one year of sales was not reached, the project established a solid technical, clinical and manufacturing foundation for rapid transition to market. Remaining needs include finalising large-scale production capacity, market access activities and continued regulatory and IPR support.