Xeltis Achieves Breakthrough Phase 3 Results for aXess
Xeltis has announced highly successful results from its aXess EU phase 3 clinical trial, marking a major milestone in the future of vascular access for patients undergoing hemodialysis.
The multicentre study, conducted across 18 sites in Europe, enrolled 120 patients living with end-stage renal disease, many of whom had previously experienced failed grafts or fistulas or were reliant on central venous catheters.
The trial met its primary endpoint and delivered results that significantly surpassed the current standard of care. Patients treated with aXess experienced superior sustained patency, fewer interventions, and high resistance to infection – outcomes that could represent a transformative step in hemodialysis treatment worldwide.
Transformative Patient Outcomes
Over the course of more than 15,000 dialysis sessions, aXess demonstrated a below 0.02% bleeding complication rate and just one cannulation-related infection explant. Such safety and efficacy outcomes are described by clinicians as unprecedented compared to existing vascular access options.
Coordinating Investigator and Head of Nephrology & Infectious Disease at AZ Sint-Jan, Brugge, commented that Xeltis’ technology is truly transformative, delivering superior sustained patency with fewer interventions and complications such as infections.
What’s more, these results demonstrate the potential to significantly change the lives of patients who often have limited options.
Innovation at the Core
Developed using Xeltis’ proprietary Endogenous Tissue Restoration (ETR) platform, aXess is designed to be gradually replaced by the patient’s own tissue, ultimately dissolving completely over time.
The device is PFAS free and engineered for near-immediate cannulation – features that not only set it apart from traditional vascular access solutions but also reduce the long-term risks faced by patients.
The Chief Executive Officer of Xeltis described the trial results as a resounding validation of their supreme confidence that aXess represents the future of hemodialysis vascular access treatment.
Meanwhile, the company’s Chief Medical Officer stated that these results are transformative for them as a company, and they look forward to maintaining this momentum as they refine and execute their commercial strategy.
Looking Ahead
With the EU trial completed, Xeltis is now turning its attention to the United States, where a phase 3 trial is already underway.
Patient recruitment is progressing, with interim results expected in 2026. This next step is anticipated to further bolster the company’s ambition to make aXess the global standard of care for dialysis patients.
Conclusion
The results of the aXess EU phase 3 trial stand as a landmark achievement for Xeltis and a beacon of hope for patients with end-stage renal disease. By combining sustained performance, infection resistance, and a safety profile previously unseen in vascular access, Xeltis is redefining the possibilities of dialysis care.
With commercialisation plans on the horizon and US trials advancing, aXess is positioned not only to transform clinical outcomes but also to set a new benchmark in restoring quality of life for dialysis patients worldwide.
News Credits: Xeltis prepares for commercial launch after strong aXess trial results
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