Xeltis, a Dutch clinical-stage company developing fully bioresorbable cardiovascular implants, has secured nearly €50 million in new financing from the European Investment Bank (EIB) and existing shareholders. The financing arrives as new peer-reviewed 12-month clinical data provide the most detailed look yet at the performance of aXess, Xeltis’ regenerative hemodialysis access conduit.

Together, the capital infusion and a growing body of clinical evidence place Xeltis in a good position as it enters its next phase: manufacturing scale-up, pivotal trial execution, and preparations for European commercialization.

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Funding Overview: Runway for Manufacturing, Hiring, and Pipeline Expansion

Xeltis’ new financing package includes:

• Up to €37.5M from the European Investment Bank
• €10M from existing shareholders, including EQT Life Sciences and Invest-NL

The company noted that these funds will directly support:

1. Upscaling Production Capacity

Xeltis will expand its production capabilities to support rising demand for clinical and early commercial supply. This includes:

• Scaling polymer scaffold fabrication
• Strengthening GMP-compliant quality systems
• Hiring for operations and engineering roles
• Preparing capacity for multiple product programs

2. Sustaining Multi-Year Clinical and Regulatory Runway

The nearly €50M investment is expected to provide runway through:

• EU pivotal trial execution
• Pivotal trial follow-up
• Regulatory submissions
• Pre-commercial market preparation

3. Supporting Broader Pipeline Development

Beyond aXess, Xeltis continues to advance regenerative pulmonary, aortic, and coronary programs built on the same supramolecular polymer platform.

The EIB, which previously invested €15M in 2021, described the funding as part of its priority to support strategic medical technologies manufactured within Europe.

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New Peer-Reviewed Data: First-in-Human 12-Month Outcomes

On November 21, 2025, The Journal of Vascular Access published the first 12-month clinical data from Xeltis’ first-in-human (FIH) study of aXess (NCT04898153). This provides the clearest evidence to date of the graft’s safety and the biological remodeling process underlying the company’s Endogenous Tissue Restoration (ETR) platform.

Study Summary

• 20 hemodialysis patients unsuitable for AV fistulae
• Prospective, single-arm, multi-center
• Assessed safety, patency, and graft remodeling

Key 12-Month Outcomes

Safety

• 100% freedom from device-related serious adverse events at 6 months
• 95% at 12 months
• No access-related infections reported
• Two deaths occurred but were unrelated to the device

This contrasts favorably with infection rates associated with PTFE grafts, which historically represent one of the highest infection burdens in dialysis access.

Patency

• Primary patency:
  • 80% at 6 months
  • 39% at 12 months
• Secondary patency:
  • 100% at both timepoints

These findings suggest that while interventions are still required, primarily for thrombosis, stenosis, and pseudoaneurysm vascular access could be consistently maintained.

Access-related interventions were needed in 61% of patients, aligning with known challenges in a high-risk population often suffering from chronic kidney disease, inflammation, and impaired vessel quality.

Evidence of Biological Remodeling

Histology at 6 months and up to 15 months showed:

• Progressive infiltration and remodeling by host cells
• Nearly complete polymer resorption by 15 months
• Evidence of vessel-like tissue formation

This provides rare, direct confirmation that ETR, gradual scaffold resorption combined with tissue ingrowth, is functioning as intended in human dialysis patients.

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Significance of These Findings in the Context of Existing Access Options

Dialysis access remains a major unmet need:

• Fistulas fail to mature in up to 40–60% of cases in some populations
• PTFE grafts present infection risks and chronic intervention burden
• Biologic grafts offer improved handling but remain susceptible to degeneration

The aXess graft is designed as a third category: a synthetic scaffold that becomes a living autologous conduit.

Peer-reviewed data demonstrating:

• No infections
• Consistent secondary patency
• Progressive tissue regeneration

…represent important milestones in validating a regenerative alternative to PTFE.

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About Xeltis

Xeltis is a Netherlands-based medtech company developing transformative vascular implants that are gradually replaced by the patient’s own living tissue through a process called Endogenous Tissue Restoration (ETR). Its bioresorbable supramolecular polymer scaffolds are being applied to hemodialysis access grafts, heart valves, and other cardiovascular indications, with the goal of reducing long-term complications associated with permanent synthetic implants.

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About the European Investment Bank (EIB)

The European Investment Bank is the lending arm of the European Union and one of the world’s largest multilateral financial institutions. Owned by the EU’s 27 member states and headquartered in Luxembourg, the EIB finances projects that advance EU policy objectives, supporting innovation, infrastructure, climate and environmental action, small and medium-sized enterprises, and strategic technologies, primarily through long-term loans, equity, and guarantees.

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About EQT Life Sciences

EQT Life Sciences (formerly Life Sciences Partners, LSP) is one of Europe’s largest and most experienced life sciences investors. With a track record of more than 30 years, the firm has raised roughly €3–3.5 billion across multiple funds and invested in over a hundred healthcare and life sciences companies worldwide, focusing on innovative therapeutics, medical devices, diagnostics, and healthtech. EQT Life Sciences is part of the global private capital group EQT.