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

Información del proyecto

XTEND U

Identificador del acuerdo de subvención: 190163665

DOI

10.3030/190163665

Proyecto cerrado

Fecha de la firma de la CE 14 Diciembre 2022

Fecha de inicio 1 Enero 2023

Fecha de finalización 31 Diciembre 2025

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

€ 2 351 596,25

Aportación de la UE

€ 1 646 117,00

Coordinado por

C LINDHEXTEND AKTIEBOLAG
Sweden

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

Período documentado: 2025-01-01 hasta 2025-12-31

Resumen del contexto y de los objetivos generales del proyecto

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

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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.