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Up to €37.5m investment from the EIB, consisting of €10m upfront with optionality to further increase by an additional €27.5m
€10m investment from existing shareholders including EQT Life Sciences (EQT) and Invest-NL

Follows the announcement of excellent EU pivotal trial data highlighting the transformative potential of aXess in hemodialysis treatment

European market approval and US pre-market approval of aXess expected in 2026

EINDHOVEN, The Netherlands, 2 December 2025 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that it has secured nearly €50m of new financing, consisting of up to €37.5m from the EIB, supported under the European Commission’s Invest EU programme, and €10m from existing investors, including EQT, investing from its LSP Health Economics Fund 2, and Invest-NL. The proceeds raised will be used to advance aXess into commercialization, including upscaling production and hiring, and supporting the continued development of its broader pipeline.

The financing follows the announcement of exceptional clinical data from Xeltis’ EU pivotal trial investigating the patency, safety, and performance of aXess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy. The study successfully met its primary endpoints, demonstrating standout sustained patency rates and significant improvements across all key measures, such as reduced infection rates and fewer interventions, compared to standard of care. A US pivotal trial for aXess is also well underway, and is heading towards pre-market approval, with interim data expected in 2026.

Together, these results and the investment from the EIB, position Xeltis to advance confidently toward commercialization, bringing aXess – a revolutionary, first of its kind treatment – to market.

Eliane Schutte, Chief Executive Officer, Xeltis, commented:

“We are deeply grateful for the continued support of the EIB and our existing investors and proud of the confidence they have shown in Xeltis at this key moment for the company. 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 commercialization. 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 hemodialysis patients.”

Robert de Groot, Vice President, European Investment Bank, said:

“Xeltis is at the cutting-edge of their field, directly contributing to improved outcomes for dialysis and cardiovascular patients. As such, we are proud to back Xeltis with €37.5m of venture debt, helping it move from breakthrough science to real world treatment across Europe. This partnership shows how targeted European innovation investment accelerates medical progress and strengthens Europe’s MedTech leadership.”

Alexander Goemans, Chief Financial Officer, Xeltis, added:

“The EIB is a valued partner for Xeltis and we sincerely appreciate their ongoing support. Momentum is building rapidly, and the EIB’s commitment, along with the continued support of our existing investors, provides a strong foundation for Xeltis to move confidently towards commercialization.”

The financing will also be used to further develop Xeltis’ broader pipeline of transformative implants, developed using Xeltis’ proprietary Endogenous Tissue Restoration (ETR) platform technology, which incorporates Nobel-prize winning breakthroughs in PFAS free polymer technology. Xabg, Xeltis’ coronary artery bypass conduit and second product in clinical development, has demonstrated exceptionally positive 24-month follow-up results, outcomes unprecedented for an artificial bypass surgery conduit. Xeltis is also making significant progress across other indications in its pipeline.

Contacts

Xeltis
Eliane Schutte, CEO
Alexander Goemans, CFO
info@xeltis.com

Optimum Strategic Communications
Nick Bastin, Vici Rabbetts, Aoife Minihan
+44 (0) 208 078 4357
xeltis@optimumcomms.com

 

About Xeltis

Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXessTM, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases.

Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.

Visit the Xeltis website for more details: https://xeltis.com/