Restorative Devices
The world’s first polymer-based technology platform designed to enable cardiovascular restoration – through ETR
Living Devices
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
Pulmonary Heart Valve
Blood vessels – CABG
Blood vessels – Hemodialysis
Aortic Heart Valve
Scientific Literature
- Acta Biomaterialia
Inflammatory and regenerative processes in bioresorbable synthetic pulmonary valves up to two years in sheep - Journal of Biomedical Materials Research – Part A.
Tissue response, macrophage phenotype, and intrinsic calcification induced by cardiovascular biomaterials - Frontiers in Cardiovascular Medicine
A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials - Cardiovascular Pathology
Morphology and mechanisms of a novel absorbable polymeric conduit in the pulmonary circulation of sheep
- The Journal of Thoracic and Cardiovascular Surgery
A novel restorative pulmonary valved conduit in a chronic sheep model: mid-term haemodynamic function and histological assessment - EuroIntervention
Mid-term performance of a novel restorative pulmonary valved-conduit: preclinical results - EuroIntervention
Acute performance of a novel restorative transcatheter aortic valve: preclinical results
- EuroIntervention
Restorative valve therapy by endogenous tissue restoration: tomorrow’s world? - The Journal of Thoracic and Cardiovascular Surgery (JTCVS)
Total Cavo-Pulmonary Connection with a New Bio-Absorbable Vascular Graft First Clinical Experience. - Biomaterials
In Situ Heart Valve Tissue Engineering Using a Bioresorbable Elastomeric Implant – From Material Design to 12 Months Follow-up in Sheep - Science Translational Medicine
50 Shades of Red
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
Jean-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.