Xeltis Achieves Breakthrough Results in EU Phase 3 Trial for Revolutionary Hemodialysis Vascular Access Device
核心洞察
Xeltis (搜索)' aXess (搜索) EU phase 3 trial involving 120 end-stage renal disease (搜索) patients across 18 European sites successfully met its primary endpoint, demonstrating superior sustained patency compared to standard arteriovenous grafts (搜索).
The restorative vascular access (搜索) conduit showed major improvements across all clinical metrics, requiring fewer interventions and exhibiting high infection resistance with only one cannulation-infection related explant among 120 patients.
Built on Xeltis (搜索)' proprietary Endogenous Tissue Restoration platform, aXess (搜索) gradually dissolves while being replaced by patients' own living tissue, offering near-immediate cannulation capability and a below 0.02% bleeding complication rate across over 15,000 dialysis sessions.
Xeltis (搜索) has announced successful results from its aXess (搜索) EU phase 3 trial, marking a significant breakthrough in hemodialysis vascular access (搜索) treatment. The multicentre study met its primary endpoint and demonstrated major improvements compared to standard of care across all key clinical metrics.
Trial Design and Patient Population
The prospective study was conducted across 18 EU sites and involved 120 patients with end-stage renal disease (搜索) requiring vascular access (搜索) for hemodialysis therapy. Many participants presented with challenging clinical histories, having previously experienced failed arteriovenous grafts (搜索) or fistulas, or had relied on central venous catheters for dialysis access.
Superior Clinical Outcomes
The trial results showed that aXess (搜索) delivered superior sustained patency across both primary and secondary outcomes compared to other arteriovenous grafts (搜索) (AVG). The device demonstrated fewer required interventions and showed a lower re-intervention rate compared to standard options. Additionally, aXess exhibited high infection resistance when compared to fistulas.
"Xeltis (搜索)' technology is truly transformative, delivering superior sustained patency along with fewer interventions and complications, such as infections," said An De Vriese, Coordinating Investigator of the aXess (搜索) EU pivotal trial and Head of Nephrology & Infectious Disease at AZ Sint-Jan, Brugge. "This is unprecedented in our industry and heralds a new dawn in sustainable treatment options for patients."
Exceptional Safety Profile
Across more than 15,000 dialysis sessions, aXess (搜索) demonstrated remarkable safety metrics with a below 0.02% bleeding complication rate. The device showed exceptional infection resistance, with only one cannulation-infection related partial explant recorded across the entire 120-patient population.
Revolutionary Technology Platform
Developed through Xeltis (搜索)' proprietary Endogenous Tissue Restoration (ETR) platform technology, which utilizes Nobel-prize winning breakthroughs in polymer technology, aXess (搜索) represents a paradigm shift in vascular access (搜索) devices. The implant is gradually replaced over time by patients' own living tissue and dissolves completely during the regeneration process. The device is PFAS-free and designed to offer near-immediate cannulation capability.
"These results signify a resounding validation of our supreme confidence that aXess (搜索) represents the future of hemodialysis vascular access (搜索) treatment," said Eliane Schutte, Chief Executive Officer of Xeltis (搜索). "After this clear demonstration of its excellence on all clinical fronts, not to mention being PFAS free, Xeltis is now poised to enter the next stage of its journey as a commercial stage company bringing benefits for patients, providers and payers."
Commercial Strategy and Future Development
With these transformative results, Xeltis (搜索) is now preparing to move forward with commercialization, aiming to establish a new standard in vascular access (搜索) for dialysis patients. The company's Chief Medical Officer, Paulo Neves, emphasized the significance of the achievement: "These results are transformative for us as a Company, and we look forward to continuing this momentum as we develop our commercial strategy."
A parallel US phase 3 trial is currently underway, with patient recruitment progressing and interim results expected in 2026. The combination of successful EU trial results and ongoing US development positions Xeltis (搜索) to potentially transform the treatment landscape for millions of patients requiring hemodialysis access worldwide.