Xeltis passes 50% enrollment in US pivotal trial for aXess graft
Xeltis has confirmed that its US pivotal trial for aXess, a bioabsorbable vascular access implant for hemodialysis, has passed the halfway mark for patient recruitment. More than half of the planned 140-patient target has now been enrolled across 20 sites in the United States, the Eindhoven-based medtech announced on 2 July 2026.
The prospective, multicentre study is evaluating patency, safety, and performance of aXess in adults with end-stage renal disease (ESRD) who require reliable vascular access for regular dialysis. The trial holds FDA Breakthrough Device Designation, which was granted in November 2024 and is intended to accelerate development and review of devices that offer more effective treatment for life-threatening conditions.
The device and the data behind it
aXess is built on Xeltis's proprietary Restorex platform, which uses an advanced synthetic polymer scaffold to promote regeneration of the patient's own tissue. The implant is gradually absorbed, leaving behind what the company describes as a living, long-lasting vessel. The approach is designed to address the two principal failure modes of conventional vascular access: thrombosis and infection.
The US trial builds on EU pivotal data presented earlier this year. Twelve-month results from the European study showed secondary patency rates that the company says exceeded historical benchmarks for conventional arteriovenous grafts and were comparable to matured arteriovenous fistulas, alongside lower reintervention rates and improved resistance to infection. Those data supported the granting of CE mark approval, enabling commercial sales in Europe.
Shawn Gage, Vice President of US Clinical Affairs at Xeltis, said the milestone "reflects the strong momentum behind the aXess programme as we advance towards FDA approval in the US." National Principal Investigator Dr John Lucas III of Lucas Surgical Group said the device represented "a unique technology" and expressed encouragement at the study's continued progress.
Market context and competitive landscape
Vascular access failure is a persistent clinical and economic burden in ESRD care. Approximately 800,000 patients in the United States currently live with ESRD, the majority of whom depend on hemodialysis three times per week. Conventional options, including synthetic polytetrafluoroethylene grafts and surgically created arteriovenous fistulas, carry well-documented complication rates that generate significant downstream costs for renal care providers.
Xeltis is not alone in targeting this space. Several companies are developing next-generation vascular access solutions, ranging from improved synthetic grafts to tissue-engineered constructs. However, a fully bioabsorbable device that transitions to native tissue would represent a genuinely differentiated proposition if the clinical profile observed in Europe holds in a broader US population. The involvement of high-volume academic centres, including Brigham and Women's Hospital, Emory University Hospital, and Duke University Hospital, adds credibility to the trial's real-world generalisability.
The company's investor base, which includes DaVita Venture Group, EQT Life Sciences, and Kurma Partners, reflects strategic alignment with renal care at the payer level as well as the venture community. Completion of enrollment and subsequent primary endpoint readout will be the next significant catalyst for the programme, with FDA submission timing likely to follow in 2027 or 2028 depending on protocol-specified follow-up duration.