Living implants move from clinical progress towards manufacturing scale-up
Xeltis’ latest funding round highlights the manufacturing and regulatory work needed to move a novel implant platform into wider clinical use.
Dutch-US MedTech company Xeltis has raised an additional €20.5 million to support the next stage of development and commercialisation of its implant technology.
The company develops artificial vessels and valves designed to be gradually replaced by a patient’s own living tissue. The new investment will support the European rollout of its aXess vascular-access device, completion of a US pivotal trial, preparation for an FDA submission and further development of its XABG and XPAD clinical programmes.
A significant part of this next phase is manufacturing scale-up. For innovative implant developers, clinical progress and production readiness must advance together. Increasing output requires repeatable material performance, controlled processes, traceability, quality assurance and evidence that the manufactured device remains consistent as production volumes grow.
The announcement is a useful signal for SMEs developing biomaterial-based or implantable products. Reaching patients at scale depends not only on demonstrating that a technology works, but on building a credible route through validation, regulation and commercial manufacturing.
Original article
Xeltis raises an additional €20.5m of funding to advance aXess™ toward FDA approval and US commercial launch