aXess^™ is a medical device for hemodialysis access.

The vascular access device is implanted in a single procedure, acting as a scaffold ready for cannulation and gradually transforming into each patient’s own living vessel for reliable, long-term access.

aXess^™ is different by design. Built on Nobel Prize-winning science, the aXess^™ device leverages Restorex^® supramolecular electrospun polymer enabling the body’s natural healing. At implantation, the patient’s own cells infiltrate the porous aXess^™ design, allowing instantaneous blood nesting for fast hemostasis and early cannulation.

Overtime, a controlled transformation to the patient’s own living vessels is achieved – for reliable access. Reducing infection risk, intervention burden and catheter dependency to positively impact patients’ quality of life.

This has a positive shift on hemodialysis patient journey, toward a reliable living access and better quality of life.

aXess^™ has received CE mark enabling commercialization across Europe.

In the United States, aXess^™ FDA was granted Breakthrough Device Designation by FDA and is still an investigational device, limited by federal law to investigational use only, and not yet approved for commercial distribution.

Unlike AV grafts, aXess^™ is designed to be replaced by living tissue. aXess^™ provides reliable hemodialysis access with fewer redos, and unlike fistulas, it provides a fast implantable solution allowing cannulation after 14 days.

aXess^™ is designed for early cannulation. The IFU currently recommends 14 days after implantation.

ESRD patients requiring vascular access for hemodialysis.

aXess^™ is designed to provide long-term clinical and economic benefits for patients and care team by reducing infection risk, intervention burden and catheter dependency. aXess^™ delivers these outcomes thanks to complementary layers of value with its design, manufacturing, clinical evidence, familiar implanting technique and life-long better economics.

Benefits include:

• Reliable access as aXess^™ transform to each patient’s vessel. Infection resistance and fewer emergency interventions.

• Lower reintervention burden, infection risk and catheter dependency. Delivering meaningful life-time cost saving, with up to €13k saving per patient on intervention devices, and up to €30k per each avoided blood stream infection.

• Early cannulation (IFU recommends after 14 days)

• Familiar implanting procedure, benefits of soft and strong material for ease of suturing, and fast hemostasis for predictable and time efficient dialysis sessions (in >95% of cannulations, hemostasis achieved in 5–10 mins.^[9]

A substantial global body of evidence supports aXess^™ clinical outcomes.

Recently Xeltis presented 12-month EU aXess^™ pivotal multi-center trial with 120 patients; of which many complex patients [66% prior CVC, 34% prior AVF (17% with multiple attempts), 6% failed AVG].

Data demonstrates vs historical benchmarks:

• Low infection rates – Clinically relevant access-related infection rate of ~3% per patient-year, comparable to 4% for arteriovenous fistulas (AVFs), 9% for arteriovenous grafts (AVGs) and 22% for central venous catheters (CVCs)

• Reduced reintervention rates – Up to 60% fewer reinterventions compared with standard synthetic grafts (AVGs) and up to 30% fewer vs matured arteriovenous fistulas (AVFs).

• Sustained vascular access performance – 79% secondary patency at 12 months, in line with matured AVF patency and better than AVG.

Post-implantation, aXess^™ is a scaffold ready to cannulate and the transformation to a living vessel starts at implantation. You can see it. Blood immediately enters the porous Restorex^® scaffold; fibrin and cells infiltrate and begin early tissue integration — supporting fast cannulation. IFU currently indicates cannulation can begin after 14 days.

Over time the polymer is gradually resorbed and replaced by the patient’s own tissue (largely resorbed over ~2 years based on preclinical sheep data), forming a living, compliant vessel.

In the EU aXess^™ is now CE marked and is available in selected-sites, patients should consult their healthcare provider for access. In the US aXess^™ enrollment into its pivotal trial is ongoing. Patients can consult their healthcare provider to assess eligibility.

To learn more about the US clinical program following this link: usa.axesspivotal.com

Reliable vascular access is essential for effective hemodialysis treatment and significantly impacts patient outcomes and quality of life. Today Hemodialysis access is not a “create and forget” procedure.

It is a lifelong journey – for the patient, and for the care team behind them. Vascular access must be created, maintained and often repeatedly restored to ensure reliable blood flow for dialysis. aXess^™ was designed to address these challenges.