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

Informazioni relative al progetto

XTEND U

ID dell’accordo di sovvenzione: 190163665

DOI

10.3030/190163665

Progetto chiuso

Data della firma CE 14 Dicembre 2022

Data di avvio 1 Gennaio 2023

Data di completamento 31 Dicembre 2025

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 2 351 596,25

Contributo UE

€ 1 646 117,00

Coordinato da

C LINDHEXTEND AKTIEBOLAG
Sweden

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

Periodo di rendicontazione: 2025-01-01 al 2025-12-31

Sintesi del contesto e degli obiettivi generali del progetto

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

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.