Restorative Devices

The world’s first polymer-based technology platform designed to enable cardiovascular restoration – through ETR

Living Devices

artificial heart valves
CABG
Hemodialysis-access

Xeltis restorative pulmonary heart valve
Fully synthetic restorative pulmonary heart valve for Right Ventricular Outflow Tract reconstruction, overtime turning into a living heart valve made of patient’s own tissue.
Status: Three ongoing clinical trials in pediatric patients.
Results:  Clinical results published in Frontiers in Cardiovascular Medicine.

Xeltis aortic heart valve
Xeltis restorative electrospun aortic heart valve for trans-apical and potentially transcatheter implantation, overtime turning into a living heart valve made of patient’s own tissue.
Status: Proof-of-concept from long-term preclinical trials completed.
Results: Preliminary results published in Eurointervention.

The XABG device is a restorative, synthetic, electrospun blood vessels for CABG surgery, overtime turning into a living vessel made of patient’s own tissue.

Status: Proof-of-concept and preclinical trials complete; First-in-human trial initiation.
Results: First-ever synthetic CABG device to succeed in preclinical trials, with graft consistently open for 6-12 months; proven tissue regeneration in the internal part of the vessel, protecting from thrombosis and other negative side effects; long term durability with successful endothelialization at one year.

The aXess graft is a restorative, synthetic, electrospun blood vessel for arteriovenous hemodialyisis access, overtime turning into a living vessel made of patient’s own tissue.

Status: Proof-of-concept and preclinical trials completed; First-in-human trial initiation.
Results: Successful formation of functional, living 20 cm long graft in one-year preclinical study. Improved healing compared to commercially available synthetic grafts ePTFE.

Key Technology Benefits

01 Technology safety

Xeltis’ restorative technology has been used for over 60 patient/years across cardiovascular applications to date

02 Reduced intervention

Xeltis’ cardiovascular devices may help reduce the need for repeated replacement procedures, invasive vessel harvesting or long-term medication

03 Growth potential

New, living devices developed with patient’s own tissue have the potential to grow as patients grow-up.  Long-term clinical data will further provide supporting evidence

04 Low infection

Xeltis’ restorative devices may help reduce infection rates from recurrent operations, vein harvesting surgery or devices permanently implanted in the body

05 Availability

Xeltis’ implants are off-the-shelf devices made of polymers and ready to use. The devices do not depend on animal tissue or human tissue supplies

06 Cost-effectiveness

Xeltis’ restorative devices may help reduce the overall cost of blood vessel and heart valve replacement

Product Pipeline

Pediatric conduit

Clinical – 5 years

Pulmonary Heart Valve

Clinical – 4 years

Blood vessels – CABG

Clinical initiation

Blood vessels – Hemodialysis

Clinical initiation

Aortic Heart Valve

Preclinical

Scientific Literature

Presented Data

2021

  • ISACB Atlanta 2021
    One Year Patency and Remodeling of Restorative Polymeric Coronary Artery Bypass Grafts in an Ovine Model
    Tissue Engineered Valve In Situ Pathophysiology and Translational Challenges
  • ISACB Tokyo 2021
    Alec Clowes Memorial Lecture: Cardiac Valve Replacement Technology in 2021: Challenges, Innovation, Trends and Opportunities

2020

  • CHSS & ECHSA Joint Meeting 2020
    Early Results on a Novel Bioabsorbable Pulmonary Valved Conduit
  • HVS & ICTEHV 2020
    A Novel Pulmonary Valve Homing Device – One and Two Year Results

2019

  • 2019 ISACB+ISVTE
    Preclinical results on small diameter blood vessels

2018

  • EACTS 2018 Techno College
    One-year case study on pediatric pulmonary valve
  • TCT 2018 annual meeting
    Long-term aortic valve in vivo trial results
  • ECHSA 2018 annual meeting
    Preliminary 1-year clinical results on pulmonary valve
  • ACC 2018 annual meeting 
    Heart valve preclinical and clinical trial program overview

2017

  • TCT 2017 annual meeting
    12-month preclinical data on aortic heart valve
  • EuroPCR 2017 annual meeting
    6-month preclinical data on aortic heart valve.
  • 7th World Congress of Pediatric Cardiology & Cardiac Surgery (WCPCCS)
    Xeltis 31-month feasibility clinical trial data of a novel bioabsorbable vascular graft in modified Fontan procedure

2016

  • 30th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting 
    Xeltis 2-year feasibility clinical trial data of a novel bioabsorbable vascular graft in modified Fontan procedure – mid-term results
  • 30th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting
    Xeltis 1-year in vivo data of a novel bioabsorbable pulmonary heart valved conduit
  • 96th American Association for Thoracic Surgery (AATS) annual meeting
    Xeltis 1-year feasibility clinical trial data showed significant improvement in patients’ general conditions.
  • 3rd Heart Valve Society (HVS) annual meeting
    Xeltis 1-year feasibility clinical trial data show significant improvement in patients’s general conditions.
  • 10th World Biomaterials Congress (WBC) annual meeting
    Preclinical data on ETR validated potential of Xeltis technology to “guide the restoration of a patient’s natural tissue into a functional living vascular replacement.”

Nobel Prize-Awarded Science

Professor Jean-Marie LehnJean-Marie Lehn, Nobel Laureate.
Awarded 1987 Nobel Prize in Chemistry for pioneering supramolecular chemistry, the science at the basis of Xeltis’ technology.

“Supramolecular chemistry enables Xeltis technology by providing unique biochemical and biomechanical properties, delivering solutions to issues faced by traditional materials over the course of decades.”

Professor Lehn is a Scientific Advisor to Xeltis.

The Xeltis technology platform comprises investigational heart valve and blood vessel devices that are not available for sale