Spurred by a positive clinical trial readout recently, Xeltis has raised €47.5m ($55.1m) to advance commercialisation efforts for aXess, a vascular access implant graft that encourages the development of new natural tissue in kidney disease patients undergoing haemodialysis.
The Netherlands-headquartered company obtained €37.5m ($43.5m) of the proceeds from the European Investment Bank (EIB) under the European Commission’s (EC) Invest EU programme, and €10m ($11.6m) from existing investors, including EQT, and Invest-NL.
Developed using Xeltis’ Endogenous Tissue Restoration (ETR) technology platform, aXess acts as a temporary scaffold that triggers a patient’s body to grow new natural tissue, with new natural tissue vessel growth absorbing the implant over time. The purpose of such implants is to repair, bypass or replace sections of blood vessels during surgical procedures. The intended indication for aXess is patients with end-stage renal disease requiring vascular access to start or maintain haemodialysis therapy.
While fistulas, a surgically created connection between an artery and a vein, have historically been one of the most common approaches in haemodialysis, fistula maturation (vascular wall thickening) is a common challenge that can result in thrombosis (clotting) or stenosis (vessel narrowing).
In September 2025, Xeltis completed a pivotal trial of the implant at 18 sites across Europe. The results demonstrated that aXess achieved superior sustained patency across both primary and secondary outcomes versus other arteriovenous grafts (AVG), with fewer interventions required. The implant also reflected a lower re-intervention rate versus standard of care (SoC) and high infection resistance compared to grafts.
The aXess implant is currently also involved in a US pivotal trial (NCT06494631), with interim data expected in 2026.
Xeltis CEO Eliane Schutte said: “The EU pivotal trial for aXess has delivered exceptional data, and with this new financing, we now have both the validation and resources to move forward toward commercialisation.
“We are now looking to expand our production facilities and hire the critical staff that we will need to bring aXess to the market and transform vascular access treatment for haemodialysis patients.”
The global vascular graft market is growing at a CAGR of 5.7% and forecast to almost double in value to $1bn by 2034, according to GlobalData analysis.
Xeltis also plans to use the proceeds to advance its broader implant portfolio. The company’s second product in clinical development is Xabg, a coronary artery bypass conduit for maintaining blood flow in patients with multi-vessel atherosclerotic coronary artery disease. The device is currently being evaluated in clinical trials at various sites across the EU with preliminary data demonstrating Xabg to be “functioning well”, according to Xeltis.
