Xeltis Announces Breakthrough Clinical Data for aXess Regenerative Vascular Graft, Demonstrating Superior Safety and Efficacy Over Standard AVF and AVG in Hemodialysis Access

Sep 24, 2025 22:15 CST Updated 22:15

Xeltis

Cardiovascular Treatment and Repair Device Developer

Xeltis Announces ItsArtificial Vessel aXessPivotal Clinical Trial (aXess EU）The successful data from the trial demonstrated that aXess has revolutionary potential in the field of hemodialysis treatment.

aXess EU is a prospective study designed to evaluate the patency, safety, and performance of the Xeltis-developed artificial blood vessel, aXess, in end-stage renal disease patients requiring vascular access to initiate or maintain hemodialysis. This study is being conducted across 18 centers in Europe.

Specific Research Results

Compared with the standard therapy, aXess has achieved significant improvements in all key clinical indicators.

Compared with other arteriovenous grafts (AVG), aXess demonstrated superior sustained patency rates in both primary and secondary endpoints, with fewer interventions.
Compared with AVF, aXess has a lower re-intervention rate and high anti-infectivity.

The majority of patients participating in the trial had a history of arteriovenous graft or dialysis fistula failure, or had relied on central venous catheters (CVC), further underscoring the significance of the study findings—despite the severe health challenges faced by the patients.

Safety

Among all 120 patients, there was only one case of partial artificial vessel removal due to puncture-related infection, indicating that aXess has extremely high resistance to infection.

aXessEnables nearly instantaneous puncture operations, with a bleeding complication rate of less than 0.02% in over 15,000 dialysis treatments.

These data demonstrate that aXess has unprecedented safety and efficacy characteristics, outperforming the current standard of care in all aspects.

PI Evaluation

"Xeltis' technology is truly revolutionary, achieving excellent long-term patency while reducing the number of interventions and complications such as infections. This is unprecedented in our industry and heralds a new dawn for sustainable patient treatment solutions."

---An De Vriese AZ Sint-Jan

Executive Evaluation

"This result strongly confirms our firm belief --- aXess represents the future of vascular access treatment for hemodialysis. After fully demonstrating its superior clinical performance, coupled with its PFAS-free characteristics, Xeltis is now ready to enter the commercialization phase, creating value for patients, medical institutions, and payers."

---Eliane Schutte CEO of Xeltis

"We would first like to express our heartfelt gratitude to all participants in the pivotal EU trials: the team of scientists who developed this technology, the clinicians who trust in the potential of our therapy, the dialysis clinics and caregivers, and the patients who have chosen our product for treatment. These outcomes are transformative for our company, and we will maintain this momentum as we formulate our commercial strategy."

---Paulo Neves Chief Medical Officer of Xeltis

aXess

aXessIs a device used forRestorative synthetic electrospun blood vessels for arteriovenous hemodialysis access, over time, transform into autologous vessels identical to the patient's own blood vessels.

aXessPrepared by electrospinning technology, it possesses a dense porous microstructure. Due to the presence of these porous microstructures, the patient's own tissue can quickly fill into them and eventually form a "living" blood vessel (identical to the patient's own blood vessels).

aXessThe technology adopted is called: Endogenous Tissue Restoration (ETR). ETR is a new treatment method that enables the patient's own body to naturally regenerate new blood vessels or heart valves.

ETR is throughXeltisThe porous structure of the products is achieved, which are made from bioabsorbable polymers and based on technology developed from Nobel Prize-winning research.

Application of ETR Technology,XeltisNot limited toaXess, currentlyXeltisIt has been expanded to include the pulmonary valve, aortic valve, and coronary artery bypass grafting (CABG).

aXess Demonstration

Xeltis

XeltisXeltis AG is a clinical-stage medical device company developing the most advanced polymer-based cardiovascular therapeutic repair devices.XeltisThe repair devices include those used for coronary artery bypass grafting surgery and hemodialysis vascular access, heart valves, and small-diameter blood vessels.

XeltisIt was formed by the merger of two enterprises incubated by Dutch/Swiss universities and currently operates in the Netherlands and the United States.