Xeltis Releases aXess Study Data for Hemodialysis Treatment

Xeltis announced new 12-month clinical data from the aXess multi-center EU pivotal trial, which enrolled 120 patients in 22 clinical trial sites from nine European countries, demonstrating the transformative potential of aXess in hemodialysis treatment.

The data show strong and higher secondary patency of aXess compared to conventional arteriovenous grafts (AVG), requiring fewer interventions, lower re-intervention rate compared to current care standards, and high infection resistance compared to grafts.

“The 2 pillars of aXess are reduced Interventions and low intervention rates. The short Time to Hemostasis is very important for improving the quality of life of the patient,” said co-principal study investigator Dr. An De Vriese, head of the Department of Internal Medicine and Division of Nephrology and Infectious Disease at AZ Sint-Jan Brugge, Belgium.

The aXess pivotal study enrolled a real-world patient population, in which most patients (69%) previously used a central venous catheter (CVC) and had a failed fistula. Findings demonstrated strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient year, alongside a substantial reduction in infection burden. Compared with alternative access options using published benchmark data, patency‑related reinterventions were 60% lower than AVGs and 30% lower than arteriovenous fistulas (AVF), meaning fewer access procedures for patients. At one year, the access‑related infection rate was 3%, versus 22% for CVCs and 9% for AVGs.

“These are tremendous results and represent the first large-scale clinical dataset of its kind generated in Europe,” Xeltis CEO Eliane Schutte stated. “The data demonstrate that aXess is safe and easy to implant, and by 12 months transforms into a tissue-like, pulsating conduit. With this level of clinical evidence, we can now move forward with the commercialization of aXess and begin delivering it to patients in real-world clinical practice. Patients deserve better options, and this technology has the potential to transform outcomes and save lives.”

The findings build on earlier evidence from the six-month EU pivotal trial results, which demonstrated significantly improved clinical outcomes compared with ePTFE AVGs, benchmarked against established objective performance criteria, and reconfirm earlier findings observed across previous studies. Importantly, these outcomes are further reinforced by the durability demonstrated across Xeltis’ broader clinical experience, including excellent 24-month first-in-human outcomes from a 20-patient European study, as well as long-term clinical cases with follow-up now exceeding four years, providing evidence of longevity and sustained function over time.

Taken together with the newly available 12-month pivotal trial data, this body of evidence underscores both the clinical benefit and long-term durability of the technology. CE mark approval was obtained in record time, enabling Xeltis to commercialize aXess in Europe.

“The combination of a reduced intervention burden, strong infection resistance, early cannulation capability, and a short Time to Hemostasis represents a significant advance for patients and clinicians alike,” commented Dr. Augusto Ministro, professor of Vascular Surgery at ULS Santa Maria, Portugal. “These attributes address many of the persistent challenges associated with conventional vascular access, making aXess a compelling option for improving durability, usability, and overall patient outcomes.”

Built on Nobel Prize-winning science, aXess leverages Restorex breakthrough polymer technology, transforming into the patient’s own tissue, forming a living vessel for sustained vascular access and reducing intervention burden and catheter dependency.

Xeltis is a medtech company developing implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for people requiring hemodialysis access grafts or cardiovascular replacements. The company’s proprietary Restorex platform uses an advanced polymer implant that regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, long-lasting vessels in place. Xeltis’ most advanced product currently under commercial development is aXess, an implantable blood vessel for hemodialysis vascular access. Xeltis’ technology can potentially be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the United States. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL,as well as other public and private investors.