TECHNOLOGY

Restorex®

Supramolecular electrospun polymer, transforming into a living tissue.

A bioresorbable supramolecular polymer, based on Nobel Prize-winning technology.

At implantation the patient’s own cells infiltrate the porous Restorex® material, allowing instantaneous blood nesting, fibrin and cells infiltrate and begin early tissue integration. Over time a controlled transformation to the patient’s own living vessels is achieved – a therapeutic process called Endogenous Tissue Restoration (ETR).

The Restorex® supramolecular polymer enables Endogenous Tissue Restoration (ETR).

Our Endogenous Tissue Restoration (ETR) process

Endogenous Tissue Restoration (ETR) is a process in which the body’s natural healing response is used to create a new, functional blood vessel.

Implantation and onset of healing – Fast hemostasis, on-set of healing, polymer resorption

Connective Tissue – Early capillaries, continued polymer absorption

Tissue maturation – Mature neointima with smooth muscle, endothelial lining

Fully Transformed Vessel – Compliant vessel designed for long-lasting, reliable vessel

Built on Nobel Prize-winning technology.

The Restorex® polymer is based on supramolecular chemistry, developed from Nobel prize-winning research by Prof. Jean-Marie Lehn. Free from intentionally introduced PFAS, the polymer is electrospun into a microporous scaffold that supports tissue integration and transformation into each patient’s own functioning vessel.

Watch world famous chemist Bert Meijer, who is also an independent adviser to Xeltis, on Optimum TV discussing the potential for supramolecular polymers in modern medicine.
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Restorex® supramolecular polymer technology is the most significant breakthrough in vascular replacement technology in over 60 years.

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Xeltis’ Restorex® supramolecular polymer technology is backed by strong research.

Key findings to date across preclinical and clinical research have been low infection rates, high patency rates and reduced intervention rates and a consistent process of natural healing.

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300

Nearly 300 patients implanted
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25

>25 patients with 5 year follow up

20,000

Nearly 20,000 successful hemodialysis cannulation sessions
Watch Xeltis’s Chief Medical Officer, Paulo Neves speaking on Optimum TV about the successful clinical data from the aXess EU pivotal trial.
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Watch Xeltis Medical Advisory Board member Frans Moll speaking on Optimum TV highlighting the rising issue of PFAS in the medical industry.
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Watch Xeltis VP of US Clinical Affaires, Shawn Gage speaking at the AAKP Global innovation summit about Xeltis’ vision for transforming vascular access in hemodialysis.
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BENEFITS

Compared to existing treatments, Xeltis’ transformative vascular implants are implanted in a clinical technique physicians are familiar with, while offering

Reduced reinterventions

Lower rates of infection & rejection

Durable & patent access

Scalability & ease of storage

Xeltis is developing medical devices to address key areas of unmet need in vascular replacement and break the cycle of complications and reinterventions.

Visit our aXess™ page to learn more about vascular access for hemodialysis.
aXess™
FREQUENTLY ASKED QUESTIONS

FAQ

Restorex® is a bioabsorbable supramolecular polymer, electrospun into a porous microstructure implant, that transforms over time into the patient’s own living vessel or valve, in a process that is called endogenous tissue restoration (ETR).
Its microporous scaffold structure allows the patient’s own cells to infiltrate and form new tissue and microvascular network, gradually replacing the scaffold with the patient’s own tissue for reliable performance.

Endogenous Tissue Restoration (ETR) is a therapeutic process that enables the body to rebuild its own blood vessels or heart valve structures using a bioresorbable implant scaffold. Over time, the implant is gradually resorbed and replaced by the patient’s own tissue, forming a living, compliant vessel or valve.

Xeltis’ implants are made from advanced bioresorbable supramolecular polymers, engineered with a porous microstructure. After implantation:
  • The implant provides immediate vessel or valve functionality
  • The patient’s cells migrate into the porous Restorex® scaffold.
  • Fibrin and cells infiltrate and begin early tissue integration with new tissue forming within the implant.
  • Over time the supramolecular polymer is gradually resorbed.
A living blood vessel or heart valve remains.

Traditional vascular graft materials do not integrate and remain permanent foreign materials in the body. Xeltis implants are designed to transform into the patient’s own tissue.
Potential advantages include:
  • Reduced risk of thrombosis (blood clots)
  • Reduced risk of stenosis (narrowing)
  • Reduced risk of calcification
  • Reduced infection risk, and antibiotic treatment becomes an option for managing infection risk.

Xeltis uses Restorex®, a proprietary supramolecular polymer, based on Nobel-Awarded science, manufactured through electrospinning technology.
This material creates a highly porous scaffold that supports early tissue integration, forming new, healthy tissue within the implant. Over time the supramolecular polymer is gradually resorbed. A living blood vessel or heart valve remains.

Yes. Xeltis implants are bioresorbable, meaning they are designed to gradually break down and be resorbed by the body while new tissue develops. Unlike permanent synthetic implants, the goal is to leave behind living, functional tissue.

Yes, by promoting a living vessel that adapts and heals. In a recent EU pivotal multi-center trial across 120 hemodialysis patients, including 66% of complex patients, Xeltis’ technology demonstrated reduced need for repeated interventions vs historical benchmarks for synthetic grafts.[6]

Xeltis’ Restorex® platform is supported by global body of clinical evidence with close to 300 patients from first‑in‑human studies, prospective multi-center trials, and peer‑reviewed publications across its vascular access and cardiac applications.
Based on this extensive clinical evidence Xeltis gained CE marking of aXess™, for hemodialysis indication. aXess™ was also granted Breakthrough Device Designation by FDA where a US pivotal clinical trial is ongoing.
Published and ongoing studies continue to evaluate safety, patency, tissue restoration, and long-term outcomes.

Post-implantation, you can see the transformation starts in front of your eyes, blood immediately enters the porous Restorex® scaffold; fibrin and cells infiltrate and begin early tissue integration.
Over time the supramolecular 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 or valve.

Yes, clinical data and results from Xeltis programmes have been published in peer-reviewed journals and presented at leading medical conferences.
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