APPLICATIONS

Current vascular treatment options can leave patients facing ongoing complications, repeated procedures and poor long-term outcomes.

Xeltis is developing medical devices designed to break this cycle by enabling the body to transform the implant into living, long-lasting tissue.

Today, Xeltis is focused on addressing these areas of high unmet need

Vascular access for end-stage renal disease patients requiring hemodialysis

Coronary arterial bypass surgery for cardiovascular disease patients

Peripheral arterial bypass surgery for peripheral arterial occlusive disease patients

Pulmonary heart valve for congenital heart malformations requiring valve replacement surgery

The Challenge

Hemodialysis access in end-stage renal disease patients

End-stage renal disease (ESRD) is a life-threatening condition that often requires lifelong hemodialysis treatment.

Hemodialysis access is not a ‘create and forget’ procedure. Vascular access must be created, maintained and often repeatedly restored to ensure reliable blood flow for dialysis. The burden on patients and healthcare systems continues to grow as the prevalence of chronic kidney disease increases worldwide.

  • 850 million of  kidney disease patients globally
  • 5th leading cause of death globally by 2040
  • Less than 25% of patients survive five years following diagnosis
  • $140 billion spent on chronic kidney disease each year worldwide
  • $50 billion spent annually on dialysis treatment alone
  • 5 million patients rely on routine hemodialysis every year
  • 6% annual growth in the global dialysis patient population
To perform hemodialysis, reliable vascular access is essential. Today, patients typically receive a temporary catheter, arteriovenous fistula (AVF) or arteriovenous graft (AVG).
However, each option has significant limitations, including complications, repeat procedures and challenges in achieving long-term access durability.
aXessTM
CURRENT OPTIONS
AVF

An arteriovenous fistula (AVF) is a passage created by joining and enlarging an artery and a vein in the patient’s arm.

It is generally a longer lasting option.

Disadvantages

  • Takes time to develop or mature:
    4 weeks to 4 months
  • Many fail to mature (up to 60%)
AVG

An arteriovenous graft (AVG) is a small plastic tube implanted in the patient’s arm to connect an artery and a vein.

Most grafts can be used between a few days and within three weeks after implanting.

Disadvantages

  • Risk of occlusion and early abandonment
  • Increases risk of infection and blood clot
CVC

A central venous catheter (CVC) is a larger tube implanted in the patient’s neck to provide access to larger veins.

It provides immediate dialysis access.

Disadvantages

  • Has more than 20% risk of infection, as its tip is located near the heart

24-month FIH data

  • Excellent patency and safety profile
  • Low reintervention rates
  • 0% cannulation related infections
  • Three times lower reintervention rate compared to standard ePTFE AVG’s

Secondary Patency

81%

AVG

54%

*As presented at Veith 2024 by Prof. Moll. Halbert et al. 2020

The Solution

Vascular Access Implant 

aXess™ is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access.

It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess™ vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections.

A first-in-human trial of aXess™ demonstrated a significant improvement in performance compared to other hemodialysis vascular access solutions.
The EU pivotal trial completed its enrollment of 120 patients in more than 9 EU countries. The pivotal trial achieved its primary goal, confirming and building upon the results from the initial first-in-human study. The findings demonstrated higher patency rates and reduced infection and intervention rates compared to the current standard of care. The US pivotal trial is currently enrolling patients.
See more details in aXess™.
aXessTM

The Challenge

Coronary artery disease and bypass surgery

Coronary artery disease is a leading cause of cardiovascular death, linked to 17.9 million deaths each year, growing at a rate of 9% annually. When coronary arteries become blocked, patients may require Coronary Artery Bypass Grafting (CABG) surgery to restore blood flow to the heart.

Key Facts

  • 1 million CABG patients each year
  • 20% of vein grafts fail within a year
  • 75% of vein grafts fail within 10 years
  • 40% suffer complications
  • €111 billion spent annually on cardiovascular disease in Europe
  • $318 billion spent annually on cardiovascular disease in the US

Current CABG procedures often require the removal of multiple veins from the leg, increasing surgical burden and the risk of complications.

This highlights the need for more durable and less invasive coronary bypass solutions.

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The Solution

Coronary Artery Bypass Implant

Xabg™ is an implant based on the Nobel-Awarded science Restorex® supramolecular polymer, which transforms to the patient’s own vessel to enable continued blood flow in patients with coronary artery disease.

Xeltis’ solution has the potential to transform the bypass surgery landscape, eliminating the need for vein harvesting and its associated burden on patients and healthcare systems.

Proof-of-concept and preclinical trials have been completed in animals, demonstrating the implant to remain open 12 months, with healthy tissue regeneration in and around the vessel leading to long-term durability. First human trial data showed the implants remain patent at 1 year.
A first-in-human trial is underway. Click here to find out more.
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The Challenge

Pulmonary heart valve replacement

Peripheral Artery Disease (PAD) affects more than 200 million people worldwide and can lead to severe pain, chronic wounds, limb loss, and loss of independence.

When arteries in the legs become severely blocked, patients may require bypass surgery to restore blood flow and preserve the limb.

While endovascular treatments are widely used, bypass surgery remains the preferred option for many patients with complex disease, failed prior interventions, or a need for durable long-term outcomes. However, current bypass procedures often rely on harvesting the patient’s own vein, creating limitations and highlighting the need for more durable and readily available vascular graft solutions.

The Solution

Peripheral Artery Bypass Implant

Xpad™ is an implant based on the Nobel-Awarded science Restorex® supramolecular polymer, which transforms to the patient’s own vessel to enable continued blood flow in peripheral arteries above-the-knee and below-the-knee.

XPAD clinical trial for peripheral arterial occlusive disease (PAOD) is ongoing.

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FUTURE EXPANSIONS

The Challenge

Pulmonary heart valve replacement

Pulmonary heart valve disease affects around 30,000 patients per year. Many of them are children born with congenital heart defects.

1 in 5 pulmonary heart valves fail within a year

Current pulmonary valve replacement options have poor performance and can fail prematurely due to narrowing of the heart valve caused by stenosis, calcification and endocarditis, often leading to repeat interventions.

The Solution

Pulmonary Heart Valve

Xplore-2 is a pulmonary heart valve implant which turns into the patient’s own living valve.

Made with Restorex® supramolecular polymer technology, Xplore-2 has the potential to significantly reduce the reintervention rate associated with current valve replacement devices, and the related burden on healthcare systems.

12-month clinical trial data showed no incidence of reoperation, reintervention or device-related death. Other trials are ongoing.
Visit xplore2md.com to learn more.
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FREQUENTLY ASKED QUESTIONS

FAQ

Current options for vascular replacements have significant limitations for patients, who often face a cycle of complications and reinterventions.
Xeltis aims to break this cycle by providing new, transformational treatment options. Xeltis’ current focus is on developing medical devices for several areas of high unmet need.
  • Vascular access for end-stage renal disease patients requiring hemodialysis – aXess™ now CE marked
  • Coronary artery bypass surgery for coronary artery disease patients Peripheral bypass surgery for patients with peripheral arterial occlusive disease (PAOD)
  • Pulmonary heart valve for patients with congenital heart malformations requiring valve replacement surgery

The aXess™ Hemodialysis Conduit is indicated for patients with end-stage renal disease (ESRD) who require arteriovenous hemodialysis access in the upper extremities.

aXess™ for hemodalysis treatment is now CE marked.
Xpad™ for peripheral arterial occlusive disease (PAOD) and Xabg™ for Coronary artery disease patients are in active human clinical trials.

aXess™ US pivotal trial has completed more than half of its enrolment. See PR announcement from July 2nd.
Xpad™ early feasibility and Xabg™ FIH clinical trials are ongoing.

aXess™ US pivotal trial is ongoing and progresses as planned.
aXess4All Post-market-surveillance trial is ongoing in European sites.
Xpad™ for peripheral arterial occlusive disease (PAOD) and Xbag™ for cardiovascular disease patients clinical trials are ongoing.

aXess™ for hemodialysis treatment is CE marked, allowing its commercial availability in Europe.

aXess™ US pivotal trial is ongoing, halfway enrollment milestone was completed in June 2026. Xeltis plans to seek FDA marketing authorization after completion of its US pivotal trial.

Standard reimbursement for hemodalysis access creation applies to aXess™ in Europe.
aXess™ was granted Breakthrough Device Designation by FDA.

Xeltis’ clinical programs are seeking to address the significant challenges faced by vascular surgery patients, offering transformative implants with reduced rates of infection, rejection and need for reintervention.

Visit our Patients page for an overview of our ongoing clinical trials.

Patients