Xeltis Secures Nearly €50m to Advance aXess Toward Commercialization and Scale-Up

The EIB financing consists of €10 million upfront, with the option to access an additional €27.5 million as Xeltis progresses toward commercialization.

Xeltis, a pioneer in regenerative cardiovascular implants, has secured nearly €50 million in new financing to propel the commercialization of aXess, its first-of-its-kind vascular access graft that enables the body to naturally create living blood vessels. The new funding package includes:

• Up to €37.5 million in venture debt from the European Investment Bank (EIB), supported by the European Commission’s InvestEU programme

• €10 million from existing investors, including EQT (via its LSP Health Economics Fund 2) and Invest-NL

The EIB financing consists of €10 million upfront, with the option to access an additional €27.5 million as Xeltis progresses toward commercialization.

Transformative Clinical Results Drive Investment Momentum

The new financing follows the release of exceptional clinical data from Xeltis’ EU pivotal trial evaluating aXess in adult patients with end-stage renal disease requiring vascular access for hemodialysis.

The trial:

• Met all primary endpoints

• Demonstrated sustained patency rates far superior to conventional grafts

• Showed lower infection rates

• Required fewer interventions

• Confirmed strong biocompatibility and patient safety

These clinical outcomes position aXess as a revolutionary, first-of-its-kind treatment in vascular access care. A US pivotal trial is also well underway, with interim data expected in 2026, moving toward FDA pre-market approval.

Financing to Power Scale-Up, Hiring, and Manufacturing Expansion

The newly secured funding will enable Xeltis to:

• Scale up manufacturing capacity for commercial launch

• Recruit critical operational, quality, and clinical teams

• Prepare regulatory submissions in both the EU and the United States

• Advance its broader pipeline of regenerative implants

Xeltis’ CEO Eliane Schutte emphasized the significance of this milestone:

“The EU pivotal trial delivered exceptional data, and with this financing, we have the validation and resources to move toward commercialization. We are expanding production facilities and hiring the teams needed to bring aXess to market and transform vascular access treatment for hemodialysis patients.”

EIB: Supporting Europe’s MedTech Leadership

EIB Vice President Robert de Groot highlighted the importance of supporting breakthrough medical technologies:

“Xeltis is on the cutting-edge of their field, directly contributing to improved outcomes for dialysis and cardiovascular patients. We are proud to back Xeltis with €37.5 million, helping it move from breakthrough science to real-world treatment across Europe.”

The investment aligns with the EIB Group’s TechEU programme, designed to support high-impact innovators. Through TechEU, the EIB Group aims to deploy €80 billion across the EU, mobilizing up to €250 billion in investments to strengthen Europe’s technological resilience and future prosperity.

Expanding a Groundbreaking Regenerative Implant Platform

Beyond aXess, Xeltis is advancing multiple breakthrough devices built using its proprietary Endogenous Tissue Restoration (ETR) platform—technology that stimulates the patient’s own body to regrow vascular structures around fully resorbable implants.

ETR leverages PFAS-free polymer technology rooted in Nobel Prize-winning scientific advances.

Pipeline highlights include:

• Xabg, a next-generation coronary artery bypass conduit

  • Demonstrated exceptionally positive 24-month clinical results

  • Shows outcomes unprecedented for artificial bypass grafts

• Additional indications in various stages of clinical and preclinical development

These innovations position Xeltis not only as a leader in vascular access but as a global frontrunner in regenerative cardiovascular solutions.

Looking Ahead

Chief Financial Officer Alexander Goemans emphasized growing momentum:

“The EIB’s commitment, together with our investors’ support, provides a strong foundation for our path to commercialization.”

With nearly €50 million in fresh capital, strong pivotal trial results, and a fast-expanding clinical pipeline, Xeltis is poised to enter a decisive phase—bringing transformative regenerative implants to markets in Europe and beyond.