Xeltis Secures $55 Million to Advance aXess™ Regenerative Vascular Access System Toward Global Commercialization

Recently, an innovative medical device companyXeltisAnnouncement Completed $55 million financing (approximately RMB 390 million), for the acceleration of its core product aXess™ Regenerative Vascular Access SystemClinical and Commercial Progress.

This funding will support Xeltis in key registration studies in Europe and the United States, production line expansion, and early market promotion, marking the official entry of regenerative vascular implant technology into the scaled application phase.

# The "Regeneration" Revolution in Vascular Access

In the field of chronic kidney disease and dialysis treatment, establishing long-term, stable vascular access has always been a clinical challenge.
Traditional methods mainly rely onArteriovenous Fistula (AVF)OrArteriovenous Graft (AVG)The former matures slowly and has a high failure rate; the latter is prone to infection and blockage, and patients often require multiple surgeries for replacement.

Globally, there are approximately 50 million patients with end-stage renal disease, and more than 3 million new dialysis catheter surgeries are performed each year, posing a significant healthcare burden.
Against this backdrop, "regenerative vascular access" that combines rapid availability with long-term patency is considered the next breakthrough direction.

This is also the core track that Xeltis focuses on — achieving a fundamental transformation from artificial materials to living tissue by guiding the patient's own tissues to "regenerate" new blood vessels within the body.

# "Tissue Regeneration Engineering" Originated from Europe

Xeltis was founded in 2006, with its headquarters located in Zurich, Switzerland, and is a global leader inEndogenous Tissue Restoration (ETR)Medical Device Development Company.
The company focuses on using degradable polymer scaffolds to induce the patient's own tissue to grow gradually within the body and replace the implant, eventually forming a permanent living blood vessel or valve.

Its core platform——ETR Technology, unlike traditional biomaterials or coating modification approaches, it utilizes highly controllable polymer structure design to trigger the body's natural repair mechanisms after implantation. Over time, the synthetic scaffold gradually degrades and disappears, replaced by functional tissue formed by the patient’s own body. This means patients do not need to replace the implant, and long-term immune rejection can also be avoided.

Currently, Xeltis' product pipeline mainly focuses on the two major fields of cardiovascular and hemodialysis, aiming to reconstruct the long-term standard for vascular implants through the concept of "living alternatives."

# Product Introduction

aXess™ Regenerative Vascular Access System

aXess™ is Xeltis' flagship product, designed to provide safer and longer-lasting vascular access for hemodialysis patients.
It is a construction utilizing ETR technology.Vascular Access Conduit, which can gradually be replaced by the patient's own tissue in vivo, thereby forming a "self-repairing" new blood vessel.

Compared with traditional artificial blood vessels (ePTFE and other materials), aXess™ has the following advantages at the same time:

• Rapid Availability: Can be used shortly after surgery, without waiting for AVF maturation;

• Long-term patency: Regenerated tissue has natural vascular properties, reducing the risk of thrombosis and blockage;

• Low infection rate: No permanent residual of heterologous materials, reducing immune and inflammatory responses.

Currently, aXess™ has been approved FDA Breakthrough Device Designation, and is advancing pivotal clinical trials concurrently in Europe and the United States. The first U.S. patient has successfully undergone implantation surgery, with early data indicating favorable safety and blood flow performance.

Xabg: Coronary Artery Bypass Grafting Conduit (CABG conduit)

In addition to the dialysis field, Xeltis also applies the ETR platform to cardiac surgery.
Xabg Project Targets Coronary Artery Bypass Grafting (CABG) Surgery, Aiming to Replace Autologous Vein Grafts by Implanting Regenerative Conduits to Induce the Formation of New Coronary Artery Vessels in Patients.

In 2025, Xeltis announced the 24-month follow-up results of the European clinical trial, showing good patency and bio-integration, providing important evidence for the feasibility of artificial vein replacement.

Through the two major products, aXess and Xabg, Xeltis is gradually building a "Regenerative Vascular Ecosystem" centered on ETR, covering multi-scenario applications from dialysis access to coronary artery bypass grafting.

Xeltis PV Absorbable Pulmonary Valve

Xeltis PV is developed based on the ETR platform.Bioabsorbable Pulmonary Valve System, mainly used for right ventricular outflow tract (RVOT) reconstruction in children and adolescent patients with congenital heart disease.

The valve is made of a special polymer material. After implantation, it can be gradually absorbed by the human body over several years, while new "living valve and vascular access" is reconstructed by the patient's own cells, offering long-term functionality and growth potential.

Compared with traditional allogeneic valves or animal tissue valves, Xeltis PV does not require long-term anti-rejection treatment and can naturally expand with the growth of children, thereby reducing the need for repeated open-chest surgeries.

Currently, the product is undergoing a global multicenter pivotal clinical trial (Xplore-2 Pivotal Study), covering 15 hospitals in Europe, the United States, and Asia, with research subjects including congenital heart disease patients aged 2–22. Early data shows that the valve performs well in structural integration and function maintenance, providing a more ideal solution for postoperative care in children with congenital heart disease.

# This Round of Financing: Accelerating Global Commercialization Process

Xeltis' total financing amount this time is$55 million, jointly invested by multiple European healthcare funds and long-term industrial capital.
The funds will be mainly used in the following directions:

• Advance the Key Registration Trial of aXess™, completing synchronized clinical validation in Europe and the United States;

• Building Production and Quality Control Systems, supporting the first batch of commercial-scale production;

• Strengthen Market Education and Doctor Training, establish a global promotion network;

• Accelerate the R&D of Xabg and subsequent product lines, expanding more vascular indications.

The company expects that aXess™ will complete its first market access around 2026, becoming the world's first approved "renewable vascular access system."

# Conclusion: The Inflection Point of Medical Device in Regenerative Medicine

In the two major chronic disease fields of cardiovascular and dialysis treatment, Xeltis represents a completely new engineering approach:It no longer "repairs blood vessels," but insteadReconstruct Blood Vessels。

From artificial materials to autologous tissue, from one-time surgery to long-term biological integration, this transformation is not only a technological innovation but also an evolution of medical philosophy.
With the clinical advancement and funding support of aXess™ in place, regenerative vascular technology may move from the laboratory to the mainstream market within the next few years.

For the global vascular intervention industry, this may be the signal that the "era of tissue engineering" has truly begun.