Xeltis Submits IPO Prospectus Highlighting aXess Regenerative Vascular Graft with 100% One-Year Secondary Patency Rate

Nov 30, 2025 22:10 CST Updated 22:10

Xeltis

Cardiovascular Treatment and Repair Device Developer

XeltisIn the journal "The Journal of Vascular Access》Published on its renewable artificial blood vesselsaXessOne-year data. Study shows: StudyBoth primary and secondary outcomes demonstrated favorable safety and performance, reinforcing the efficacy of the artificial blood vessel.aXessThe potential to improve patient vascular access outcomes.

This study isAn ongoing prospective, single-arm, multi-center first-in-human study aimed at evaluating the safety and performance of this product in hemodialysis patients unsuitable for arteriovenous fistula creation.

Specific Research Data (20 Patients)

At 6 months post-operation, the incidence of related serious adverse events was 0%, and at 12 months it was 5% (i.e., 95% did not occur), with no access-related infections observed. During this period, there were 2 cases of non-related deaths.
At 6 months post-operation, the primary patency rate andSecondary Patency Rate80% and 100%, respectively,1
At 12 months post-operation,Primary Patency Rate andSecondary Patency RateRespectively39% and 100%.
61% of patients required access-related interventions, mainly due to thrombosis/stenosis (71%) and pseudoaneurysm (29%).
Histology showed tissue remodeling at 6 months and nearly complete polymer absorption at 15 months.

Research Conclusion

aXess has demonstrated good safety and performance within 1 year, but long-term verification through pivotal trials is still required.

aXess

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

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.